COV-BARRIER: A Study of Baricitinib (LY3009104) in Participants With COVID-19
Study Details
Study Description
Brief Summary
The reason for this study is to see if the study drug baricitinib is effective in hospitalized participants with COVID-19.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Baricitinib + Standard of Care (SOC) 4 milligrams (mg) of baricitinib (given as two 2 mg tablets) administered orally every day (QD) with standard of care. |
Drug: Baricitinib
Given orally
Other Names:
|
Placebo Comparator: Placebo + SOC Placebo (given as two placebo tablets) administered orally QD with standard of care. |
Drug: Placebo
Given orally
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO]) [Day 1 to Day 28]
Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).
- Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2 [Day 1 to Day 28]
Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.
Secondary Outcome Measures
- Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital [Day 10]
The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis.
- Number of Ventilator-Free Days [Day 1 to Day 28]
Number of days free of invasive mechanical ventilation.
- Time to Recovery [Day 1 to Day 28]
Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant's maximum OS for the day. NIAID-OS 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.)
- Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4 [Day 4]
Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
- Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7 [Day 7]
Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
- Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10 [Day 10]
Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
- Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14 [Day 14]
Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
- Duration of Hospitalization [Days 1 to Day 28]
Duration of hospitalization.
- Percentage of Participants With a Change in Oxygen Saturation From < 94% to ≥ 94% From Baseline [Day 10]
Percentage of participants with a change in oxygen saturation from < 94% to ≥ 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status.
- Overall Mortality [Day 1 to Day 28]
Number of deaths by Day 28.
- Duration of Stay in the Intensive Care Unit (ICU) in Days [Day 1 to Day 28]
Duration of stay in the ICU in days.
- Time to Clinical Deterioration (One-category Increase on the NIAID-OS) [Day 1 to Day 28]
The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. A higher score is representative of worse clinical outcome with a score of 8 being the highest and representing death.
- Time to Resolution of Fever in Participants With Fever at Baseline [Day 1 to Day 28]
Time to resolution of fever in participants with fever at baseline was calculated using cox proportional hazard regression model adjusted for baseline disease severity (OS 4, OS 5, OS 6), age (<65 years, >=65 years), region (United States, Europe, rest of world), and systemic corticosteroids used at baseline for primary study condition (Yes/No).
- Mean Change From Baseline on the National Early Warning Score (NEWS) [Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14]
The NEWS score is used to detect and report changes in illness severity in participants with acute illness to identify participants at risk for poor outcomes. The score is based on six physiological parameters (Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness). A score is assigned to each parameter, and the sum of the score represents the participant's risk of poor outcomes with a minimum score of 0 representing the better outcome, a score of 7 or greater reflects high clinical risk for worsening and maximum score of 19 representing the worse outcome.
- Time to Definitive Extubation [Day 1 to Day 28]
Time to definitive extubation included participants who progressed to OS 7 at any time prior to Day 28.
- Time to Independence From Non-Invasive Mechanical Ventilation [Day 1 to Day 28]
Time to independence from non-invasive mechanical ventilation was measured in days among participants who required non-invasive ventilation.
- Time to Independence From Oxygen Therapy in Days [Day 1 to Day 28]
Time to independence from oxygen therapy in days.
- Number of Days With Supplemental Oxygen Use [Day 1 to Day 28]
Number of days with supplemental oxygen use.
- Number of Days of Resting Respiratory Rate <24 Breaths Per Minute [Day 1 to Day 28]
Number of days of resting respiratory rate <24 breaths per minute.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) test or other commercial or public health assay in any specimen, as documented by either of the following:
-
PCR positive in sample collected <72 hours prior to randomization; OR
-
PCR positive in sample collected ≥72 hours prior to randomization (but no more than 14 days prior to randomization), documented inability to obtain a repeat sample (for example, due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
-
Requires supplemental oxygen at the time of study entry and at randomization.
-
Have indicators of risk of progression: at least 1 inflammatory markers >upper limit of normal (ULN) (C reactive protein [CRP], D dimer, lactate dehydrogenase [LDH], ferritin) with at least 1 instance of elevation >ULN within 2 days before study entry.
Exclusion Criteria:
-
Are receiving cytotoxic or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening.
-
Have ever received convalescent plasma or intravenous immunoglobulin [IVIg]) for COVID-19.
-
Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for ≥14 consecutive days in the month prior to study entry.
-
Strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry.
-
Have received neutralizing antibodies, such as bamlanivimab, casirivimab and imdevimab for COVID-19.
-
Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
-
Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
-
Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: Use of nonlive (inactivated) vaccinations is allowed for all participants.
-
Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry.
-
Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.
-
Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).
-
Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry.
-
Have neutropenia (absolute neutrophil count <1000 cells/microliters).
-
Have lymphopenia (absolute lymphocyte count <200 cells/microliters).
-
Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN.
-
Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <30 milliliter/minute/1.73 meters squared.
-
Have a known hypersensitivity to baricitinib or any of its excipients.
-
Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study. Note: The participant should not be enrolled (started) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28.
-
Are pregnant, or intend to become pregnant or breastfeed during the study.
-
Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
-
Are, in the opinion of the investigator, unlikely to survive for at least 48 hours after screening.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Dignity Health Mercy Gilbert Medical Center | Gilbert | Arizona | United States | 85297 |
2 | Valleywise Health | Phoenix | Arizona | United States | 85008 |
3 | St Joseph's Hospital and Medical Center | Phoenix | Arizona | United States | 85013 |
4 | Hoag Memorial Hospital Presbyterian | Newport Beach | California | United States | 92663 |
5 | Sharp Memorial Hospital | San Diego | California | United States | 92123 |
6 | San Francisco VA Medical Center | San Francisco | California | United States | 94121 |
7 | Torrance Memorial Medical Center | Torrance | California | United States | 90505 |
8 | Holy Cross Hospital Inc. | Fort Lauderdale | Florida | United States | 33308 |
9 | Westchester General Hospital | Miami | Florida | United States | 33155 |
10 | Grady Health System | Atlanta | Georgia | United States | 30303 |
11 | Atlanta VA Medical Center | Decatur | Georgia | United States | 30033 |
12 | Great Lakes Clinical Trials | Chicago | Illinois | United States | 60640 |
13 | Parkview Regional Medical Center | Fort Wayne | Indiana | United States | 46845 |
14 | Community Hospital South | Indianapolis | Indiana | United States | 46227 |
15 | Franciscan St. Francis Health | Indianapolis | Indiana | United States | 46237 |
16 | South Shore Hospital | Weymouth | Massachusetts | United States | 02190 |
17 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
18 | Renown Regional Med. Center | Reno | Nevada | United States | 89502 |
19 | SUNY Downstate | Brooklyn | New York | United States | 11203 |
20 | East Carolina University | Greenville | North Carolina | United States | 27834 |
21 | OSU Med Intl Med Houston Ctr | Tulsa | Oklahoma | United States | 74127 |
22 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
23 | Temple Univ School of Med | Philadelphia | Pennsylvania | United States | 19140 |
24 | Swedish Medical Center | Seattle | Washington | United States | 98104 |
25 | MultiCare Good Samaritan Hospital | Tacoma | Washington | United States | 98405 |
26 | Sanatorio Sagrado Corazón | Ciudad de Buenos Aires | AR | Argentina | C1039AAC |
27 | ClÃ-nica Zabala | Ciudad de Buenos Aires | AR | Argentina | C1426AAM |
28 | Hospital Z.G.A.D "Evita Pueblo" | Berazategui | Buenos Aires | Argentina | 1884 |
29 | Sanatorio de la Trinidad Mitre | Caba | Buenos Aires | Argentina | C1039AAO |
30 | Fundacion Sanatorio Guemes | Caba | Buenos Aires | Argentina | C1180AAX |
31 | Casa Hospital San Juan de Dios | Ramos Mejía | Buenos Aires | Argentina | 1704 |
32 | Hospital Interzonal General de Agudos "Eva Peron" | San Martin | Buenos Aires | Argentina | B1650 NBN |
33 | Clinica Adventista Belgrano | Caba | Ciudad Autónoma De Buenos Aire | Argentina | C1430EGF |
34 | Clinica Central S.A. | Villa Regina | Rio Negro | Argentina | R8336 |
35 | Clinica Viedma | Viedma | Río Negro | Argentina | 8500 |
36 | Hospital San Roque | Cordoba | Argentina | 5000 | |
37 | Hospital Felício Rocho | Belo Horizonte | Minas Gerais | Brazil | 30110-934 |
38 | Centro Hospitalar de Reabilitacao Ana Carolina Moura Xavier | Curitiba | Parana | Brazil | 80035-090 |
39 | CEPETI Centro de Ensino e Pesquisa em Terapia Intensiva | Curitiba | Paraná | Brazil | 82530-200 |
40 | CPCLIN | Natal | Rio Grande Do Norte | Brazil | 59025-050 |
41 | Hospital de Clinicas de Porto Alegre | Porto Alegre | RS | Brazil | 90035-903 |
42 | Hospital Carlos Fernando Malzoni Matao | Matao | Sao Paulo | Brazil | 15990-060 |
43 | Pesquisare | Santo Andre | Sao Paulo | Brazil | 09080-110 |
44 | Praxis Pesquisa Medica | Santo André | Sao Paulo | Brazil | 09090-790 |
45 | Faculdade de Medicina do ABC | Santo Andre | SP | Brazil | 09060-870 |
46 | Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP | Botucatu | São Paulo | Brazil | 18618-687 |
47 | IPECC - Instituto de Pesquisa Clinica de Campinas | Campinas | São Paulo | Brazil | 13060-080 |
48 | Hospital PUC-CAMPINAS | Campinas | São Paulo | Brazil | 13060-904 |
49 | CECIP - Centro de Estudos do Interior Paulista | Jaú | São Paulo | Brazil | 17201-130 |
50 | CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda | São Bernardo do Campo | São Paulo | Brazil | 09715-090 |
51 | Real e Benemerita Associação Portuguesa de Beneficiencia | São Paulo | Brazil | 01323-900 | |
52 | Hospital Alemão Oswaldo Cruz | São Paulo | Brazil | 01327-001 | |
53 | Universidade Federal de São Paulo - Escola Paulista de Medicina | São Paulo | Brazil | 04037-002 | |
54 | Hospital Santa Paula | São Paulo | Brazil | 04556-100 | |
55 | Casa de Saude Santa Marcelina - Centro de Pesquisa Clinica | São Paulo | Brazil | 08270-120 | |
56 | Universitätsklinikum Erlangen | Erlangen | Bayern | Germany | 91054 |
57 | Klinikum Rechts der Isar der TU München | München | Bayern | Germany | 81675 |
58 | Universitätsklinikum Schleswig-Holstein | Kiel | Schleswig-Holstein | Germany | 24105 |
59 | Klinikum Chemnitz gGmbH | Chemnitz | Germany | 09116 | |
60 | Sir Ganga Ram Hospital | New Delhi | Delhi | India | 110060 |
61 | Unity Hospital | Surat | Gujarat | India | 395010 |
62 | Medanta-The Medicity | Gurgaon | Haryana | India | 122001 |
63 | Government Medical College (GMC) Aurangabad | Aurangabad | Maharashtra | India | 431001 |
64 | Government Medical College | Nagpur | Maharashtra | India | 440003 |
65 | Ruby Hall Clinic and Grant Medical Foundation | Pune | Maharashtra | India | 411001 |
66 | Medica Superspecialty Hospital | Kolkata | West Bengal | India | 700099 |
67 | Aakash Healthcare Super Speciality Hospital | New Delhi | India | 110075 | |
68 | INMI Lazzaro Spallanzani | Roma | Rome | Italy | 00149 |
69 | Ospedale Niguarda Ca Granda | Milano | Italy | 20162 | |
70 | Nuovo Ospedale di Prato S. Stefano | Prato | Italy | 59100 | |
71 | Yokohama Municipal Citizen's Hospital | Yokohama | Kanagawa | Japan | 2210855 |
72 | Edogawa Medicare Hospital | Edagawa | Tokyo | Japan | 133 0071 |
73 | Tokyo Medical University Hachioji Medical Center | Hachioji | Tokyo | Japan | 193-0998 |
74 | Korea University Ansan Hospital | Ansan-si | Gyeonggi-do | Korea, Republic of | 15355 |
75 | Ajou University Hospital | Suwon | Gyeonggi-do | Korea, Republic of | 16499 |
76 | Seoul National University Boramae Medical Center | Seoul | Seoul, Korea | Korea, Republic of | 07061 |
77 | Seoul Medical Center | Seoul | Korea, Republic of | 02053 | |
78 | Instituto Nacional de Cardiologia Ignacio Chavez | Mexico | DF | Mexico | 14080 |
79 | Instituto Nacional de Enfermedades Respiratorias | Mexico | DF | Mexico | 14080 |
80 | Instituto Nacional de Cancerologia | Mexico City | FD | Mexico | 14080 |
81 | Instituto Nacional de Ciencias Medicas y Nutrici Salva Zubir | Mexico City | Federal District | Mexico | 14080 |
82 | Hospital General Agustín O'Horán | Yucatan | Merida | Mexico | 97000 |
83 | ITESM Campus Monterrey | Monterrey | Nuevo Leon | Mexico | 64710 |
84 | Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | Mexico | 64460 |
85 | Advanced Clinical Research, LLC | Bayamon | Puerto Rico | 00961 | |
86 | City Clinical Hospital #15 named after O.M. Filatov | Moscow | Russian Federation | 111539 | |
87 | First Moscow State Medical University n.a. Sechenov | Moscow | Russian Federation | 119991 | |
88 | Saint-Petersburg City Pokrovskaya Hospital | Saint-Petersburg | Russian Federation | 199106 | |
89 | Hospital Txagorritxu | Vitoria | Alava | Spain | 01009 |
90 | Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcon | Madrid | Spain | 28223 |
91 | Hospital Universitario Infanta Leonor-INTERNAL MED | Madrid | Spain | 28031 | |
92 | Hospital Clinico San Carlos | Madrid | Spain | 28040 | |
93 | Hospital Clínico Universitario de Valencia | Valencia | Spain | 46010 | |
94 | The Royal Cornwall Hospital | Truro | Cornwall | United Kingdom | TR1 3LJ |
95 | Barnet Hospital | Barnet | Herts | United Kingdom | EN5 3DJ |
96 | St. George's University Hospitals NHS Foundation Trust | London | United Kingdom | SW17 0QT |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-265-4559 or 1-317-615-4559) Mon - Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 17830
- I4V-MC-KHAA
- 2020-001517-21
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Placebo + Standard of Care (SOC) | Baricitinib + SOC | Placebo + SOC Follow-Up | Baricitinib + SOC Follow-Up |
---|---|---|---|---|
Arm/Group Description | Placebo tablets administered orally every day (QD) with standard of care. | 4 milligrams (mg) baricitinib administered orally QD with standard of care. | Participants did not receive drug during the Follow-Up Period. | Participants did not receive drug during the Follow-Up Period. |
Period Title: Treatment Period | ||||
STARTED | 761 | 764 | 0 | 0 |
Received at Least One Dose of Study Drug | 752 | 750 | 0 | 0 |
COMPLETED | 604 | 644 | 0 | 0 |
NOT COMPLETED | 157 | 120 | 0 | 0 |
Period Title: Treatment Period | ||||
STARTED | 0 | 0 | 613 | 645 |
COMPLETED | 0 | 0 | 588 | 615 |
NOT COMPLETED | 0 | 0 | 25 | 30 |
Baseline Characteristics
Arm/Group Title | Placebo +SOC | Baricitinib + SOC | Total |
---|---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. | Total of all reporting groups |
Overall Participants | 761 | 764 | 1525 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
57.5
(13.8)
|
57.8
(14.3)
|
57.6
(14.1)
|
Sex: Female, Male (Count of Participants) | |||
Female |
288
37.8%
|
274
35.9%
|
562
36.9%
|
Male |
473
62.2%
|
490
64.1%
|
963
63.1%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
168
22.1%
|
148
19.4%
|
316
20.7%
|
Asian |
94
12.4%
|
80
10.5%
|
174
11.4%
|
Native Hawaiian or Other Pacific Islander |
2
0.3%
|
3
0.4%
|
5
0.3%
|
Black or African American |
36
4.7%
|
39
5.1%
|
75
4.9%
|
White |
440
57.8%
|
480
62.8%
|
920
60.3%
|
More than one race |
1
0.1%
|
2
0.3%
|
3
0.2%
|
Unknown or Not Reported |
20
2.6%
|
12
1.6%
|
32
2.1%
|
Region of Enrollment (Count of Participants) | |||
Puerto Rico |
3
0.4%
|
8
1%
|
11
0.7%
|
Argentina |
101
13.3%
|
107
14%
|
208
13.6%
|
United States |
155
20.4%
|
154
20.2%
|
309
20.3%
|
Japan |
19
2.5%
|
19
2.5%
|
38
2.5%
|
United Kingdom |
7
0.9%
|
4
0.5%
|
11
0.7%
|
India |
31
4.1%
|
19
2.5%
|
50
3.3%
|
Russia |
54
7.1%
|
58
7.6%
|
112
7.3%
|
Spain |
42
5.5%
|
45
5.9%
|
87
5.7%
|
South Korea |
20
2.6%
|
16
2.1%
|
36
2.4%
|
Brazil |
165
21.7%
|
172
22.5%
|
337
22.1%
|
Mexico |
143
18.8%
|
138
18.1%
|
281
18.4%
|
Italy |
10
1.3%
|
15
2%
|
25
1.6%
|
Germany |
11
1.4%
|
9
1.2%
|
20
1.3%
|
Outcome Measures
Title | Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO]) |
---|---|
Description | Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO). |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 756 | 762 |
Number (95% Confidence Interval) [percentage of participants] |
30.5
4%
|
27.8
3.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.1800 |
Comments | ||
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 0.85 | |
Confidence Interval |
(2-Sided) 95% 0.67 to 1.08 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2 |
---|---|
Description | Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO. |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention who at baseline required oxygen supplementation and did not receive dexamethasone, or other systemic corticosteroids for the primary study condition. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 109 | 96 |
Number (95% Confidence Interval) [percentage of participants] |
27.1
3.6%
|
28.9
3.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.7280 |
Comments | ||
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.12 | |
Confidence Interval |
(2-Sided) 95% 0.58 to 2.16 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital |
---|---|
Description | The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis. |
Time Frame | Day 10 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 756 | 762 |
Number (95% Confidence Interval) [percentage of participants] |
63.5
8.3%
|
65.0
8.5%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.5444 |
Comments | ||
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.07 | |
Confidence Interval |
(2-Sided) 95% 0.86 to 1.34 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Ventilator-Free Days |
---|---|
Description | Number of days free of invasive mechanical ventilation. |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 756 | 762 |
Least Squares Mean (Standard Error) [days] |
23.7
(0.39)
|
24.5
(0.39)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0586 |
Comments | ||
Method | ANOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean difference (net) |
Estimated Value | 0.75 | |
Confidence Interval |
(2-Sided) 95% -0.0 to 1.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.399 |
|
Estimation Comments |
Title | Time to Recovery |
---|---|
Description | Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant's maximum OS for the day. NIAID-OS 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.) |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 761 | 764 |
Median (95% Confidence Interval) [days] |
11.0
|
10.0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.1453 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.11 | |
Confidence Interval |
(2-Sided) 95% 0.99 to 1.24 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4 |
---|---|
Description | Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death. |
Time Frame | Day 4 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 756 | 762 |
Day 4 NIAID-OS 1 |
4.6
0.6%
|
5.2
0.7%
|
Day 4 NIAID-OS 2 |
1.5
0.2%
|
1.5
0.2%
|
Day 4 NIAID-OS 3 |
0.8
0.1%
|
0.3
0%
|
Day 4 NIAID-OS 4 |
19.4
2.5%
|
23.6
3.1%
|
Day 4 NIAID-OS 5 |
41.0
5.4%
|
39.0
5.1%
|
Day 4 NIAID-OS 6 |
22.4
2.9%
|
21.8
2.9%
|
Day 4 NIAID-OS 7 |
8.9
1.2%
|
8.1
1.1%
|
Day 4 NIAID-OS 8 |
1.4
0.2%
|
0.4
0.1%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | Day 4 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0464 |
Comments | ||
Method | Proportional Odds Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.21 | |
Confidence Interval |
(2-Sided) 95% 1.00 to 1.47 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7 |
---|---|
Description | Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death. |
Time Frame | Day 7 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 756 | 762 |
Day 7 NIAID-OS 1 |
20.2
2.7%
|
25.2
3.3%
|
Day 7 NIAID-OS 2 |
6.6
0.9%
|
5.8
0.8%
|
Day 7 NIAID-OS 3 |
0.5
0.1%
|
0.2
0%
|
Day 7 NIAID-OS 4 |
21.2
2.8%
|
20.6
2.7%
|
Day 7 NIAID-OS 5 |
22.5
3%
|
22.5
2.9%
|
Day 7 NIAID-OS 6 |
14.5
1.9%
|
13.8
1.8%
|
Day 7 NIAID-OS 7 |
11.2
1.5%
|
10.8
1.4%
|
Day 7 NIAID-OS 8 |
3.3
0.4%
|
1.2
0.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0172 |
Comments | ||
Method | Proportional Odds Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.25 | |
Confidence Interval |
(2-Sided) 95% 1.04 to 1.49 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10 |
---|---|
Description | Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death. |
Time Frame | Day 10 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 756 | 762 |
Day 10 NIAID-OS 1 |
37.7
5%
|
40.4
5.3%
|
Day 10 NIAID-OS 2 |
9.4
1.2%
|
10.9
1.4%
|
Day 10 NIAID-OS 3 |
0.1
0%
|
0.1
0%
|
Day 10 NIAID-OS 4 |
16.2
2.1%
|
14.1
1.8%
|
Day 10 NIAID-OS 5 |
12.8
1.7%
|
12.4
1.6%
|
Day 10 NIAID-OS 6 |
8.1
1.1%
|
8.9
1.2%
|
Day 10 NIAID-OS 7 |
10.6
1.4%
|
10.4
1.4%
|
Day 10 NIAID-OS 8 |
5.1
0.7%
|
2.6
0.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0921 |
Comments | ||
Method | Proportional Odds Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.17 | |
Confidence Interval |
(2-Sided) 95% 0.97 to 1.41 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14 |
---|---|
Description | Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death. |
Time Frame | Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 756 | 762 |
Day 14 NIAID-OS 1 |
51.6
6.8%
|
56.3
7.4%
|
Day 14 NIAID-OS 2 |
11.2
1.5%
|
11.1
1.5%
|
Day 14 NIAID-OS 3 |
0.3
0%
|
0.1
0%
|
Day 14 NIAID-OS 4 |
8.0
1.1%
|
7.6
1%
|
Day 14 NIAID-OS 5 |
8.4
1.1%
|
7.3
1%
|
Day 14 NIAID-OS 6 |
3.6
0.5%
|
3.7
0.5%
|
Day 14 NIAID-OS 7 |
9.4
1.2%
|
8.9
1.2%
|
Day 14 NIAID-OS 8 |
7.5
1%
|
4.9
0.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0168 |
Comments | ||
Method | Proportional Odds Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.28 | |
Confidence Interval |
(2-Sided) 95% 1.05 to 1.56 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Duration of Hospitalization |
---|---|
Description | Duration of hospitalization. |
Time Frame | Days 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 756 | 762 |
Least Squares Mean (Standard Error) [days] |
13.7
(0.40)
|
12.9
(0.40)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0626 |
Comments | ||
Method | ANOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference (Net) |
Estimated Value | -0.76 | |
Confidence Interval |
(2-Sided) 95% -1.6 to 0.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.408 |
|
Estimation Comments |
Title | Percentage of Participants With a Change in Oxygen Saturation From < 94% to ≥ 94% From Baseline |
---|---|
Description | Percentage of participants with a change in oxygen saturation from < 94% to ≥ 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status. |
Time Frame | Day 10 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention whose oxygen saturation (based on National Early Warning Score) is < 94% at baseline and have non-missing baseline and at least 1 postbaseline observation are in this population. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 282 | 282 |
Number (95% Confidence Interval) [percentage of participants] |
52.5
6.9%
|
56.7
7.4%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.4290 |
Comments | ||
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.15 | |
Confidence Interval |
(2-Sided) 95% 0.81 to 1.63 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Overall Mortality |
---|---|
Description | Number of deaths by Day 28. |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 761 | 764 |
Number [event of death] |
104
|
65
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0018 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.57 | |
Confidence Interval |
(2-Sided) 95% 0.41 to 0.78 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Duration of Stay in the Intensive Care Unit (ICU) in Days |
---|---|
Description | Duration of stay in the ICU in days. |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention with non-missing baseline NIAID OS and at least 1 postbaseline NIAID OS observation. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 754 | 758 |
Least Squares Mean (Standard Error) [days] |
3.17
(0.313)
|
3.19
(0.315)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.9526 |
Comments | ||
Method | ANOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference (Net) |
Estimated Value | 0.02 | |
Confidence Interval |
(2-Sided) 95% -0.62 to 0.65 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.323 |
|
Estimation Comments |
Title | Time to Clinical Deterioration (One-category Increase on the NIAID-OS) |
---|---|
Description | The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. A higher score is representative of worse clinical outcome with a score of 8 being the highest and representing death. |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded from analysis. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 761 | 764 |
Median (95% Confidence Interval) [days] |
NA
|
NA
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.1831 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.887 | |
Confidence Interval |
(2-Sided) 95% 0.741 to 1.061 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Time to Resolution of Fever in Participants With Fever at Baseline |
---|---|
Description | Time to resolution of fever in participants with fever at baseline was calculated using cox proportional hazard regression model adjusted for baseline disease severity (OS 4, OS 5, OS 6), age (<65 years, >=65 years), region (United States, Europe, rest of world), and systemic corticosteroids used at baseline for primary study condition (Yes/No). |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention who had a fever at baseline. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 354 | 357 |
Median (95% Confidence Interval) [days] |
4.00
|
3.00
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0243 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.202 | |
Confidence Interval |
(2-Sided) 95% 1.017 to 1.421 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Mean Change From Baseline on the National Early Warning Score (NEWS) |
---|---|
Description | The NEWS score is used to detect and report changes in illness severity in participants with acute illness to identify participants at risk for poor outcomes. The score is based on six physiological parameters (Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness). A score is assigned to each parameter, and the sum of the score represents the participant's risk of poor outcomes with a minimum score of 0 representing the better outcome, a score of 7 or greater reflects high clinical risk for worsening and maximum score of 19 representing the worse outcome. |
Time Frame | Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention with baseline and 1 postbaseline observation. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 636 | 647 |
Day 4 |
-0.59
(0.127)
|
-0.76
(0.125)
|
Day 7 |
-0.86
(0.145)
|
-1.04
(0.143)
|
Day 10 |
-1.33
(0.160)
|
-1.45
(0.158)
|
Day 14 |
-1.41
(0.183)
|
-1.66
(0.182)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | Day 4 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.191 |
Comments | ||
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
Estimated Value | -0.17 | |
Confidence Interval |
(2-Sided) 95% -0.42 to 0.08 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.128 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | Day 7 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.278 |
Comments | ||
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
Estimated Value | -0.17 | |
Confidence Interval |
(2-Sided) 95% -0.49 to 0.14 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.161 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | Day 10 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.496 |
Comments | ||
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
Estimated Value | -0.13 | |
Confidence Interval |
(2-Sided) 95% -0.49 to 0.24 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.187 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | Day 14 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.263 |
Comments | ||
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
Estimated Value | -0.25 | |
Confidence Interval |
(2-Sided) 95% -0.70 to 0.19 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.226 |
|
Estimation Comments |
Title | Time to Definitive Extubation |
---|---|
Description | Time to definitive extubation included participants who progressed to OS 7 at any time prior to Day 28. |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention who were intubated at some point during the study. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 136 | 125 |
Median (95% Confidence Interval) [days] |
NA
|
NA
|
Title | Time to Independence From Non-Invasive Mechanical Ventilation |
---|---|
Description | Time to independence from non-invasive mechanical ventilation was measured in days among participants who required non-invasive ventilation. |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention whose baseline OS was 6 and were on non-invasive mechanical ventilation. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 187 | 183 |
Median (95% Confidence Interval) [days] |
11.00
|
12.00
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.6436 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.090 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Time to Independence From Oxygen Therapy in Days |
---|---|
Description | Time to independence from oxygen therapy in days. |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants who had an ordinal scale score of 5 or 6 at baseline. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 659 | 673 |
Median (95% Confidence Interval) [days] |
8.00
|
8.00
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.1270 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.124 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Days With Supplemental Oxygen Use |
---|---|
Description | Number of days with supplemental oxygen use. |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention who have non-missing baseline and at least 1 postbaseline observation. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 754 | 758 |
Least Squares Mean (Standard Error) [days] |
4.60
(0.221)
|
4.37
(0.222)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.3058 |
Comments | ||
Method | ANOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference (Net) |
Estimated Value | -0.23 | |
Confidence Interval |
(2-Sided) 95% -0.68 to 0.21 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.228 |
|
Estimation Comments |
Title | Number of Days of Resting Respiratory Rate <24 Breaths Per Minute |
---|---|
Description | Number of days of resting respiratory rate <24 breaths per minute. |
Time Frame | Day 1 to Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
All participants randomly assigned to study intervention who had non-missing baseline and at least 1 postbaseline respiratory rate. |
Arm/Group Title | Placebo + SOC | Baricitinib + SOC |
---|---|---|
Arm/Group Description | Placebo administered orally QD with standard of care. | 4 mg baricitinib administered orally QD with standard of care. |
Measure Participants | 743 | 745 |
Least Squares Mean (Standard Error) [days] |
9.62
(0.300)
|
9.73
(0.304)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo + SOC, Baricitinib + SOC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.7073 |
Comments | ||
Method | ANOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference (Net) |
Estimated Value | 0.11 | |
Confidence Interval |
(2-Sided) 95% -0.49 to 0.72 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.306 |
|
Estimation Comments |
Adverse Events
Time Frame | Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly. | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods. | |||||||
Arm/Group Title | Placebo | 4 Milligrams (mg) Baricitinib | Placebo Follow-up | 4mg Baricitinib Follow-up | ||||
Arm/Group Description | Placebo tablets administered orally every day (QD) with standard of care. | 4 milligrams (mg) baricitinib administered orally QD with standard of care. | Participants did not receive drug during the Follow-Up Period. | Participants did not receive drug during the Follow-Up Period. | ||||
All Cause Mortality |
||||||||
Placebo | 4 Milligrams (mg) Baricitinib | Placebo Follow-up | 4mg Baricitinib Follow-up | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 104/752 (13.8%) | 65/750 (8.7%) | 16/613 (2.6%) | 18/645 (2.8%) | ||||
Serious Adverse Events |
||||||||
Placebo | 4 Milligrams (mg) Baricitinib | Placebo Follow-up | 4mg Baricitinib Follow-up | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 135/752 (18%) | 110/750 (14.7%) | 12/613 (2%) | 18/645 (2.8%) | ||||
Blood and lymphatic system disorders | ||||||||
Anaemia | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Disseminated intravascular coagulation | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Lymphopenia | 2/752 (0.3%) | 2 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Thrombocytopenia | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Cardiac disorders | ||||||||
Acute coronary syndrome | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Acute myocardial infarction | 1/752 (0.1%) | 1 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Atrial fibrillation | 1/752 (0.1%) | 1 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Bradycardia | 1/752 (0.1%) | 1 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Cardiac arrest | 3/752 (0.4%) | 3 | 0/750 (0%) | 0 | 1/613 (0.2%) | 1 | 0/645 (0%) | 0 |
Cardio-respiratory arrest | 6/752 (0.8%) | 6 | 3/750 (0.4%) | 3 | 1/613 (0.2%) | 1 | 1/645 (0.2%) | 1 |
Cardiogenic shock | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Cardiopulmonary failure | 1/752 (0.1%) | 1 | 2/750 (0.3%) | 2 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Coronary artery thrombosis | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Myocardial infarction | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 1/613 (0.2%) | 1 | 0/645 (0%) | 0 |
Eye disorders | ||||||||
Diplopia | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Gastrointestinal disorders | ||||||||
Acute abdomen | 0/752 (0%) | 0 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 1/645 (0.2%) | 1 |
General disorders | ||||||||
Hypothermia | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Multiple organ dysfunction syndrome | 5/752 (0.7%) | 5 | 4/750 (0.5%) | 4 | 1/613 (0.2%) | 1 | 1/645 (0.2%) | 1 |
Infections and infestations | ||||||||
Bacteraemia | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Bacterial infection | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Covid-19 | 10/752 (1.3%) | 10 | 8/750 (1.1%) | 8 | 1/613 (0.2%) | 1 | 1/645 (0.2%) | 1 |
Covid-19 pneumonia | 21/752 (2.8%) | 21 | 21/750 (2.8%) | 21 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Device related bacteraemia | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Empyema | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Endocarditis staphylococcal | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Enterobacter bacteraemia | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Klebsiella bacteraemia | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Klebsiella sepsis | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Pneumonia | 10/752 (1.3%) | 10 | 8/750 (1.1%) | 8 | 0/613 (0%) | 0 | 1/645 (0.2%) | 1 |
Pneumonia bacterial | 3/752 (0.4%) | 3 | 4/750 (0.5%) | 5 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Pneumonia staphylococcal | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Pneumonia viral | 2/752 (0.3%) | 2 | 2/750 (0.3%) | 2 | 0/613 (0%) | 0 | 1/645 (0.2%) | 1 |
Pulmonary sepsis | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Sepsis | 4/752 (0.5%) | 4 | 3/750 (0.4%) | 3 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Septic shock | 24/752 (3.2%) | 24 | 13/750 (1.7%) | 13 | 4/613 (0.7%) | 4 | 5/645 (0.8%) | 5 |
Severe acute respiratory syndrome | 3/752 (0.4%) | 3 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 1/645 (0.2%) | 1 |
Staphylococcal bacteraemia | 0/752 (0%) | 0 | 2/750 (0.3%) | 2 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Staphylococcal infection | 0/752 (0%) | 0 | 2/750 (0.3%) | 2 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Staphylococcal sepsis | 1/752 (0.1%) | 1 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Systemic candida | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Urinary tract infection | 2/752 (0.3%) | 2 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Investigations | ||||||||
Fibrin d dimer increased | 0/752 (0%) | 0 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 1/645 (0.2%) | 1 |
Hepatic enzyme increased | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Transaminases increased | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Metabolism and nutrition disorders | ||||||||
Hyperglycaemia | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Metabolic acidosis | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||
Muscular weakness | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Breast neoplasm | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Nervous system disorders | ||||||||
Cerebral infarction | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Cerebrovascular accident | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 1/645 (0.2%) | 1 |
Depressed level of consciousness | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Guillain-barre syndrome | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Haemorrhage intracranial | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Ischaemic stroke | 0/752 (0%) | 0 | 2/750 (0.3%) | 2 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Neuralgia | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Paresis | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Subarachnoid haemorrhage | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Renal and urinary disorders | ||||||||
Acute kidney injury | 10/752 (1.3%) | 10 | 7/750 (0.9%) | 7 | 1/613 (0.2%) | 1 | 0/645 (0%) | 0 |
Renal failure | 3/752 (0.4%) | 3 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Renal impairment | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Reproductive system and breast disorders | ||||||||
Acquired phimosis | 0/473 (0%) | 0 | 0/490 (0%) | 0 | 1/377 (0.3%) | 1 | 0/415 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Acute respiratory distress syndrome | 3/752 (0.4%) | 3 | 2/750 (0.3%) | 2 | 1/613 (0.2%) | 1 | 1/645 (0.2%) | 1 |
Acute respiratory failure | 29/752 (3.9%) | 29 | 17/750 (2.3%) | 17 | 1/613 (0.2%) | 1 | 2/645 (0.3%) | 2 |
Dyspnoea | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Pneumomediastinum | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Pneumothorax | 2/752 (0.3%) | 2 | 6/750 (0.8%) | 6 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Pulmonary embolism | 7/752 (0.9%) | 7 | 12/750 (1.6%) | 12 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Respiratory distress | 4/752 (0.5%) | 4 | 3/750 (0.4%) | 3 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Respiratory failure | 17/752 (2.3%) | 17 | 10/750 (1.3%) | 10 | 0/613 (0%) | 0 | 1/645 (0.2%) | 1 |
Surgical and medical procedures | ||||||||
Palliative care | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Vascular disorders | ||||||||
Deep vein thrombosis | 5/752 (0.7%) | 5 | 4/750 (0.5%) | 4 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Dry gangrene | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Embolism venous | 0/752 (0%) | 0 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 1/645 (0.2%) | 1 |
Hypotension | 1/752 (0.1%) | 1 | 2/750 (0.3%) | 2 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Peripheral artery thrombosis | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Peripheral embolism | 0/752 (0%) | 0 | 1/750 (0.1%) | 1 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Shock | 0/752 (0%) | 0 | 2/750 (0.3%) | 2 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Shock haemorrhagic | 1/752 (0.1%) | 1 | 0/750 (0%) | 0 | 0/613 (0%) | 0 | 0/645 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
Placebo | 4 Milligrams (mg) Baricitinib | Placebo Follow-up | 4mg Baricitinib Follow-up | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/752 (0%) | 0/750 (0%) | 0/613 (0%) | 0/645 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Chief Medical Officer |
---|---|
Organization | Eli Lilly and Company |
Phone | 800-595-5979 |
ClinicalTrials.gov@lilly.com |
- 17830
- I4V-MC-KHAA
- 2020-001517-21