A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT04343989
Collaborator
(none)
178
3
3
11.4
59.3
5.2
Study Details
Study Description
Brief Summary
In this study invetigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a double-blinded randomized multi-center trial designed as a phase II dose-finding three arm trial with seamless adaptive transition to a phase III efficacy trial. For phase II, patients were randomized 1:1:1 ratio to three study arms and received clazakizumab at a dose of 12.5 mg, 25 mg or placebo.
Based on interim analysis, the low dose arm was dropped and the phase III portion of the study continued to enroll patients randomized 1:1 to high dose clazakizumab or placebo.
Based on interim analysis, the remaining 10 subjects at NYU will be randomly assigned to a 1:1 ratio to two arms that will receive clazakizumab at a dose of 25 mg or placebo. The NYU site will serve as the central data management site for other centers who undertake this protocol. Other sites will enroll patients based on the two arm 1:1 randomization. 60 patients at outside sites are expected to enroll.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The limited understanding of the clinical behavior of patients infected with SARS-CoV-2 (the viral organism responsible for COVID-19 disease) is evolving on a daily basis. Reports from China indicate that a subset of patients with the worst clinical outcomes may manifest cytokine storm syndrome. Hypotheses that excess cytokines may trigger a secondary hemophagocytic lymphhistiocytosis (sHLH) have been proposed. Indeed, cytokine profiles consistent with this picture were observed in Chinese patients with severe pulmonary involvement. Specifically, elevated ferritin and interleukin-6 (IL-6) were associated with fatalities among the infected patients. A role for targeted anti-inflammatory and anti-cytokine therapies in the treatment of pulmonary hyperinflammation has been proposed.
Clazakizumab is a genetically engineered humanized IgG1 monoclonal antibody (mAb) that binds with high affinity to human IL-6. This investigational agent is currently being studied as a treatment for chronic active antibody mediated rejection of renal allografts.
In this study investigators propose to administer clazakizumab to patients with life-threatening pulmonary failure secondary to COVID-19 disease.
Study Design
Study Type:
Interventional
Actual Enrollment
:
178 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a randomized, double-blind, placebo-controlled, adaptive seamless Phase II/III design (ASD). We propose the administration of an investigational drug in patients with high predicted short-term mortality secondary to COVID-19 disease. 80 patients were randomly assigned in a 1:1:1 ratio to three study arms that will receive clazakizumab at a dose of 12.5 mg, 25 mg or placebo. Interim analyses occurred every 7 days since the enrollment of the first 30 patients. Based on week 4 interim analysis the DSMB has recommendation discontinuing the low-dose 12.5 mg of clazakizumab arm. The DSMB has advised continuing enrollment in the placebo and high-dose 25mg of clazakizumab arms in a 1:1 randomization.This is a randomized, double-blind, placebo-controlled, adaptive seamless Phase II/III design (ASD). We propose the administration of an investigational drug in patients with high predicted short-term mortality secondary to COVID-19 disease. 80 patients were randomly assigned in a 1:1:1 ratio to three study arms that will receive clazakizumab at a dose of 12.5 mg, 25 mg or placebo. Interim analyses occurred every 7 days since the enrollment of the first 30 patients. Based on week 4 interim analysis the DSMB has recommendation discontinuing the low-dose 12.5 mg of clazakizumab arm. The DSMB has advised continuing enrollment in the placebo and high-dose 25mg of clazakizumab arms in a 1:1 randomization.
Masking:
Double (Participant, Investigator)
Masking Description:
This study is double-blind and therefore neither the Investigator, the subject, the Sponsor and its representatives, nor other designated study site personnel involved in running of the study will be aware of the identification of the investigational drug administered to each subject.
Primary Purpose:
Treatment
Official Title:
A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
Actual Study Start Date
:
Mar 31, 2020
Actual Primary Completion Date
:
Feb 3, 2021
Actual Study Completion Date
:
Mar 12, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Clazakizumab 25 mg
|
Drug: Clazakizumab 25 mg
The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
| Experimental: Clazakizumab 12.5 mg
|
Drug: Clazakizumab 12.5 mg
The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
| Placebo Comparator: Placebo
|
Other: Placebo
The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
Outcome Measures
Primary Outcome Measures
- Ventilator Free Survival [28 days]
Ventilator Free Survival is defined as the total number of patients who were alive and ventilator free at 28 days.
- Number of Serious Adverse Events Associated With High and Low Dose of Clazakizumab [60 days]
Secondary Outcome Measures
- Overall Patient Survival [28 days]
Overall Patient Survival is defined as the total number of patients per group who were alive at 28 days
- Overall Patient Survival [60 days]
Overall patient survival is defined as total number of patients per group who were alive at 60 days.
- Number of Participants With Change in Clinical Status [28 days]
Change in clinical status defined by an improvement in status by at least 2 score points on WHO 11-point ordinal scale, where 0 = uninfected; no viral RNA detected, 1 = asymptomatic; viral RNA detected, 2 = symptomatic; independent, 3 = symptomatic; assistance needed, 4 = hospitalized; no oxygen therapy, 5 = hospitalized; oxygen by mask or nasal prongs, 6 = hospitalized; oxygen by NIV or high flow, 7 = intubation and mechanical ventilation, pO2/FiO2 >/= 150 or SpO2/FiO2 >/= 200, 8 = mechanical ventilation pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors, 9 = mechanical ventilation pO2/FiO2 < 150 and vasopressors, dialysis, or ECMO, and 10 = Dead
- Number of Participants With a Change in Clinical Status [60 days]
Change in clinical status defined by an improvement in status by at least 2 score points on WHO 11-point ordinal scale, where 0 = uninfected; no viral RNA detected, 1 = asymptomatic; viral RNA detected, 2 = symptomatic; independent, 3 = symptomatic; assistance needed, 4 = hospitalized; no oxygen therapy, 5 = hospitalized; oxygen by mask or nasal prongs, 6 = hospitalized; oxygen by NIV or high flow, 7 = intubation and mechanical ventilation, pO2/FiO2 >/= 150 or SpO2/FiO2 >/= 200, 8 = mechanical ventilation pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors, 9 = mechanical ventilation pO2/FiO2 < 150 and vasopressors, dialysis, or ECMO, and 10 = Dead
- Number of Clazakizumab-expected Adverse Events [60 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
In order to be eligible to participate in this study, the patients must meet all of the following criteria:
-
At least 18 years of age
-
Confirmed COVID-19 disease (by Cobas SARS-CoV-2 real time RT-PCR using nasopharyngeal swab sample, or equivalent test available to be performed by the NYU Langone clinical laboratory). Effort will be made to have the confirmatory test result <72 hours prior to enrollment however given overall clinical demand this may not be feasible in all cases.
-
Respiratory failure manifesting as: Acute Respiratory Distress Syndrome (defined by a P/F ratio of <200), OR SpO2 < 90% on 4L (actual or expected given higher O2 requirement) OR increasing O2 requirements over 24 hours, PLUS 2 or more of the following predictors for severe disease:
CRP > 35 mg/L Ferritin > 500 ng/mL D-dimer > 1000 mg/mL Neutrophil-Lymphocyte Ratio > 4 LDH > 200 U/L Increase in troponin in patient w/out known cardiac disease
-
Has a consent designee willing to provide informed consent on behalf of the patient (this assumes that a mechanically ventilated patients lacks capacity to consent on his/her own behalf. Should it be deemed that the patient has capacity to consent, consent may be obtained from the patient.)
-
Women of childbearing potential must be willing and able to use at least one highly effective contraceptive method for a period of 5 months following the study drug administration. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as:
-
combined (estrogen and progestogen containing) hormonal contraception combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, or transdermal)
-
progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
-
intrauterine device (IUD)
-
intrauterine hormone-releasing system (IUS)
-
vasectomized partner
-
bilateral tubal occlusion
-
true abstinence. when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence, such as calendar, ovulation, symptothermal, postovulation methods, and withdrawal are not acceptable methods of contraception.
-
Men must be willing to use a double-barrier contraception from enrollment until at 5 months after the last dose of study drug, if not abstinent.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
-
Evidence of irreversible injury deemed non-survivable even if the pulmonary failure recovers (for example severe anoxic brain injury)
-
Known active inflammatory bowel disease
-
Known active, untreated diverticulitis
-
Known untreated bacteremia
-
Pregnancy. (The protocol will exclude pregnant subjects given the lack of overall data on use of clazakizumab in pregnancy however the study team would consider a protocol revision should more than 3 potential pregnant study subjects be excluded on this basis).
-
Known hypersensitivity to the clazakizumab
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Phoenix | Arizona | United States | 85054 |
| 2 | The Johns Hopkins Hospital | Baltimore | Maryland | United States | 21205 |
| 3 | New York University School of Medicine | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Bonnie Lonze, MD, NYU Langone Health
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04343989
Other Study ID Numbers:
- 20-00392
- NCT04363502
- NCT04659772
First Posted:
Apr 14, 2020
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
| Period Title: Overall Study | |||
| STARTED | 78 | 26 | 74 |
| COMPLETED | 78 | 26 | 74 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. | Total of all reporting groups |
| Overall Participants | 78 | 26 | 74 | 178 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
63.7
(11.1)
|
65.7
(8.3)
|
59.8
(13.1)
|
62.3
(11.8)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
25
32.1%
|
10
38.5%
|
20
27%
|
55
30.9%
|
| Male |
53
67.9%
|
16
61.5%
|
54
73%
|
123
69.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
17
21.8%
|
8
30.8%
|
24
32.4%
|
49
27.5%
|
| Not Hispanic or Latino |
61
78.2%
|
18
69.2%
|
50
67.6%
|
129
72.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
7
9%
|
2
7.7%
|
9
12.2%
|
18
10.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
16
20.5%
|
4
15.4%
|
12
16.2%
|
32
18%
|
| White |
25
32.1%
|
14
53.8%
|
27
36.5%
|
66
37.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
30
38.5%
|
6
23.1%
|
26
35.1%
|
62
34.8%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
78
100%
|
26
100%
|
74
100%
|
178
100%
|
Outcome Measures
| Title | Ventilator Free Survival |
|---|---|
| Description | Ventilator Free Survival is defined as the total number of patients who were alive and ventilator free at 28 days. |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
| Measure Participants | 78 | 26 | 74 |
| Count of Participants [Participants] |
58
74.4%
|
19
73.1%
|
44
59.5%
|
| Title | Number of Serious Adverse Events Associated With High and Low Dose of Clazakizumab |
|---|---|
| Description | |
| Time Frame | 60 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
| Measure Participants | 78 | 26 | 74 |
| Number [Serious Adverse Events] |
46
|
6
|
51
|
| Title | Overall Patient Survival |
|---|---|
| Description | Overall Patient Survival is defined as the total number of patients per group who were alive at 28 days |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
| Measure Participants | 78 | 26 | 74 |
| Count of Participants [Participants] |
60
76.9%
|
20
76.9%
|
54
73%
|
| Title | Overall Patient Survival |
|---|---|
| Description | Overall patient survival is defined as total number of patients per group who were alive at 60 days. |
| Time Frame | 60 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
| Measure Participants | 78 | 26 | 74 |
| Count of Participants [Participants] |
56
71.8%
|
20
76.9%
|
46
62.2%
|
| Title | Number of Participants With Change in Clinical Status |
|---|---|
| Description | Change in clinical status defined by an improvement in status by at least 2 score points on WHO 11-point ordinal scale, where 0 = uninfected; no viral RNA detected, 1 = asymptomatic; viral RNA detected, 2 = symptomatic; independent, 3 = symptomatic; assistance needed, 4 = hospitalized; no oxygen therapy, 5 = hospitalized; oxygen by mask or nasal prongs, 6 = hospitalized; oxygen by NIV or high flow, 7 = intubation and mechanical ventilation, pO2/FiO2 >/= 150 or SpO2/FiO2 >/= 200, 8 = mechanical ventilation pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors, 9 = mechanical ventilation pO2/FiO2 < 150 and vasopressors, dialysis, or ECMO, and 10 = Dead |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
| Measure Participants | 78 | 26 | 74 |
| Count of Participants [Participants] |
50
64.1%
|
15
57.7%
|
37
50%
|
| Title | Number of Participants With a Change in Clinical Status |
|---|---|
| Description | Change in clinical status defined by an improvement in status by at least 2 score points on WHO 11-point ordinal scale, where 0 = uninfected; no viral RNA detected, 1 = asymptomatic; viral RNA detected, 2 = symptomatic; independent, 3 = symptomatic; assistance needed, 4 = hospitalized; no oxygen therapy, 5 = hospitalized; oxygen by mask or nasal prongs, 6 = hospitalized; oxygen by NIV or high flow, 7 = intubation and mechanical ventilation, pO2/FiO2 >/= 150 or SpO2/FiO2 >/= 200, 8 = mechanical ventilation pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors, 9 = mechanical ventilation pO2/FiO2 < 150 and vasopressors, dialysis, or ECMO, and 10 = Dead |
| Time Frame | 60 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
| Measure Participants | 78 | 26 | 74 |
| Count of Participants [Participants] |
54
69.2%
|
17
65.4%
|
40
54.1%
|
| Title | Number of Clazakizumab-expected Adverse Events |
|---|---|
| Description | |
| Time Frame | 60 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
| Measure Participants | 78 | 26 | 74 |
| Number [Adverse Events] |
7
|
3
|
12
|
Adverse Events
| Time Frame | 60 days | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo | |||
| Arm/Group Description | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. | |||
All Cause Mortality |
||||||
| Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/78 (28.2%) | 6/26 (23.1%) | 28/74 (37.8%) | |||
Serious Adverse Events |
||||||
| Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 24/78 (30.8%) | 6/26 (23.1%) | 33/74 (44.6%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| lymphocyte count increased | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| platelet count decreased | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| Cardiac disorders | ||||||
| atrial fibrillation | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| cardiac arrest | 14/78 (17.9%) | 6/26 (23.1%) | 19/74 (25.7%) | |||
| heart failure | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Gastrointestinal disorders | ||||||
| gastric hemorrhage | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| General disorders | ||||||
| hypotension | 1/78 (1.3%) | 0/26 (0%) | 3/74 (4.1%) | |||
| multi-organ failure | 2/78 (2.6%) | 0/26 (0%) | 0/74 (0%) | |||
| Hepatobiliary disorders | ||||||
| alanine aminotransferase increased | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| aspartate aminotransferase increased | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Infections and infestations | ||||||
| bacteremia | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| infections | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| sepsis | 2/78 (2.6%) | 0/26 (0%) | 1/74 (1.4%) | |||
| urinary tract infection | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| acidosis | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| hypermagnesemia | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Nervous system disorders | ||||||
| intracranial hemorrhage | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| muscle weakness | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| Renal and urinary disorders | ||||||
| acute kidney injury | 3/78 (3.8%) | 0/26 (0%) | 0/74 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| adult respiratory distress syndrome | 1/78 (1.3%) | 0/26 (0%) | 1/74 (1.4%) | |||
| aspiration | 0/78 (0%) | 0/26 (0%) | 2/74 (2.7%) | |||
| bronchopleural fistula | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| hypoxia | 1/78 (1.3%) | 0/26 (0%) | 1/74 (1.4%) | |||
| lower respiratory infection | 5/78 (6.4%) | 0/26 (0%) | 5/74 (6.8%) | |||
| pleural effusion | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| pneumothorax | 1/78 (1.3%) | 0/26 (0%) | 2/74 (2.7%) | |||
| respiratory failure | 6/78 (7.7%) | 0/26 (0%) | 7/74 (9.5%) | |||
| upper respiratory infection | 0/78 (0%) | 0/26 (0%) | 2/74 (2.7%) | |||
| Vascular disorders | ||||||
| visceral arterial ischemia | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Clazakizumab 25 mg | Clazakizumab 12.5 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 76/78 (97.4%) | 24/26 (92.3%) | 72/74 (97.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 17/78 (21.8%) | 11/26 (42.3%) | 32/74 (43.2%) | |||
| disseminated intravascular coagulation | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| eosinophilia | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| fibrinogen decreased | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| inr increased | 2/78 (2.6%) | 0/26 (0%) | 0/74 (0%) | |||
| lymphocyte count decreased | 10/78 (12.8%) | 0/26 (0%) | 8/74 (10.8%) | |||
| neutrophil count decreased | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| Platelet Count Decreased | 12/78 (15.4%) | 1/26 (3.8%) | 5/74 (6.8%) | |||
| thromboembolic event | 3/78 (3.8%) | 3/26 (11.5%) | 6/74 (8.1%) | |||
| Cardiac disorders | ||||||
| Atrial Fibrillation | 0/78 (0%) | 0/26 (0%) | 12/74 (16.2%) | |||
| Atrial Flutter | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Bradycardia | 1/78 (1.3%) | 0/26 (0%) | 2/74 (2.7%) | |||
| Cardiac Arrest | 1/78 (1.3%) | 2/26 (7.7%) | 1/74 (1.4%) | |||
| cardiac troponin increased | 2/78 (2.6%) | 0/26 (0%) | 0/74 (0%) | |||
| chest pain-cardiac | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| pericardial effusion | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| right ventricular dysfunction | 0/78 (0%) | 1/26 (3.8%) | 1/74 (1.4%) | |||
| sinus bradycardia | 2/78 (2.6%) | 1/26 (3.8%) | 2/74 (2.7%) | |||
| sinus tachycardia | 4/78 (5.1%) | 1/26 (3.8%) | 10/74 (13.5%) | |||
| supraventricular tachycardia | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| tachycardia | 2/78 (2.6%) | 0/26 (0%) | 1/74 (1.4%) | |||
| tachypnic | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| ventricular tachycardia | 3/78 (3.8%) | 0/26 (0%) | 0/74 (0%) | |||
| Ear and labyrinth disorders | ||||||
| hearing impaired | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Endocrine disorders | ||||||
| hyperglycemia | 2/78 (2.6%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Gastrointestinal disorders | ||||||
| abdominal distension | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| Diarrhea | 1/78 (1.3%) | 0/26 (0%) | 2/74 (2.7%) | |||
| gastric hemorrhage | 0/78 (0%) | 1/26 (3.8%) | 1/74 (1.4%) | |||
| ileus | 1/78 (1.3%) | 0/26 (0%) | 1/74 (1.4%) | |||
| lower gastrointestinal hemorrahge | 2/78 (2.6%) | 0/26 (0%) | 0/74 (0%) | |||
| oral hemorrhage | 0/78 (0%) | 0/26 (0%) | 8/74 (10.8%) | |||
| sore throat | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| thrush | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| upper gastrointestinal hemorrahge | 4/78 (5.1%) | 0/26 (0%) | 1/74 (1.4%) | |||
| vomiting | 1/78 (1.3%) | 0/26 (0%) | 1/74 (1.4%) | |||
| General disorders | ||||||
| alopecia | 1/78 (1.3%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Chills | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| epistaxis | 1/78 (1.3%) | 0/26 (0%) | 2/74 (2.7%) | |||
| fall | 3/78 (3.8%) | 1/26 (3.8%) | 1/74 (1.4%) | |||
| fever | 24/78 (30.8%) | 16/26 (61.5%) | 59/74 (79.7%) | |||
| hematoma | 3/78 (3.8%) | 0/26 (0%) | 2/74 (2.7%) | |||
| hypertension | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| hypotension | 24/78 (30.8%) | 16/26 (61.5%) | 42/74 (56.8%) | |||
| hypothermia | 3/78 (3.8%) | 0/26 (0%) | 0/74 (0%) | |||
| nasal congestion | 1/78 (1.3%) | 0/26 (0%) | 1/74 (1.4%) | |||
| non-cardiac chest pain | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| retroperitoneal hemhorrahge | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| multi-organ failure | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| Hepatobiliary disorders | ||||||
| alanine aminotransferase increased | 18/78 (23.1%) | 4/26 (15.4%) | 21/74 (28.4%) | |||
| alkaline phosphatase increased | 4/78 (5.1%) | 0/26 (0%) | 6/74 (8.1%) | |||
| aspartate minotransferase increased | 10/78 (12.8%) | 0/26 (0%) | 11/74 (14.9%) | |||
| blood bilirubin increased | 4/78 (5.1%) | 0/26 (0%) | 4/74 (5.4%) | |||
| hepatic necrosis | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| hepatobiliary disoders, other | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Infections and infestations | ||||||
| Bacteremia | 4/78 (5.1%) | 1/26 (3.8%) | 6/74 (8.1%) | |||
| cytomegalovirus infection | 0/78 (0%) | 0/26 (0%) | 2/74 (2.7%) | |||
| fungemia | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| herpes simplex reactivation | 0/78 (0%) | 1/26 (3.8%) | 0/74 (0%) | |||
| sepsis | 2/78 (2.6%) | 0/26 (0%) | 0/74 (0%) | |||
| skin & subcutaneous tissue disorders | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| skin infection | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| soft tissue infection | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| urinary tract infection | 2/78 (2.6%) | 0/26 (0%) | 10/74 (13.5%) | |||
| Metabolism and nutrition disorders | ||||||
| acidosis | 4/78 (5.1%) | 2/26 (7.7%) | 5/74 (6.8%) | |||
| blood bicarbonate decreased | 3/78 (3.8%) | 0/26 (0%) | 1/74 (1.4%) | |||
| dehydration | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| hyperkalemia | 8/78 (10.3%) | 2/26 (7.7%) | 12/74 (16.2%) | |||
| hyperlipidemia | 2/78 (2.6%) | 0/26 (0%) | 4/74 (5.4%) | |||
| hypermagnesemia | 5/78 (6.4%) | 0/26 (0%) | 4/74 (5.4%) | |||
| hypernatremia | 5/78 (6.4%) | 1/26 (3.8%) | 3/74 (4.1%) | |||
| hyperphosphatemia | 2/78 (2.6%) | 0/26 (0%) | 1/74 (1.4%) | |||
| hypoalbuminemia | 5/78 (6.4%) | 0/26 (0%) | 6/74 (8.1%) | |||
| hypokalemia | 2/78 (2.6%) | 0/26 (0%) | 5/74 (6.8%) | |||
| hyponatremia | 5/78 (6.4%) | 0/26 (0%) | 6/74 (8.1%) | |||
| hypophosphatemia | 4/78 (5.1%) | 0/26 (0%) | 3/74 (4.1%) | |||
| metabolism and nutrition disorders | 1/78 (1.3%) | 0/26 (0%) | 1/74 (1.4%) | |||
| triglycerides increased | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| weight loss | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Ankle fracture | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| Back Pain | 1/78 (1.3%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Nervous system disorders | ||||||
| Aphonia | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Blurred vision | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| cognitive disturbance | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Confusion | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| delirium | 2/78 (2.6%) | 1/26 (3.8%) | 3/74 (4.1%) | |||
| depressed level of consciousness | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| dysphagia | 0/78 (0%) | 0/26 (0%) | 3/74 (4.1%) | |||
| encephalopathy | 1/78 (1.3%) | 1/26 (3.8%) | 0/74 (0%) | |||
| intracranial hemorrhage | 1/78 (1.3%) | 1/26 (3.8%) | 0/74 (0%) | |||
| lethargy | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| muscle weakness | 0/78 (0%) | 0/26 (0%) | 3/74 (4.1%) | |||
| paresthesia | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| peripheral motor neuropathy | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| presyncope | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| seizure | 2/78 (2.6%) | 0/26 (0%) | 2/74 (2.7%) | |||
| somnolence | 1/78 (1.3%) | 1/26 (3.8%) | 1/74 (1.4%) | |||
| stroke | 2/78 (2.6%) | 0/26 (0%) | 5/74 (6.8%) | |||
| Psychiatric disorders | ||||||
| Anxiety | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| Renal and urinary disorders | ||||||
| creatinine increased | 14/78 (17.9%) | 9/26 (34.6%) | 25/74 (33.8%) | |||
| cystitis | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| hematuria | 1/78 (1.3%) | 0/26 (0%) | 1/74 (1.4%) | |||
| proteinuria | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| renal calculi | 0/78 (0%) | 1/26 (3.8%) | 0/74 (0%) | |||
| urinary frequency | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| urinary retention | 2/78 (2.6%) | 2/26 (7.7%) | 1/74 (1.4%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Aspiration | 0/78 (0%) | 0/26 (0%) | 3/74 (4.1%) | |||
| bronchopleural fistula | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| bronchopulmonary hemorrahge | 1/78 (1.3%) | 0/26 (0%) | 0/74 (0%) | |||
| dyspnea | 1/78 (1.3%) | 0/26 (0%) | 1/74 (1.4%) | |||
| hypoxia | 14/78 (17.9%) | 8/26 (30.8%) | 29/74 (39.2%) | |||
| lower respiratory infection | 2/78 (2.6%) | 2/26 (7.7%) | 9/74 (12.2%) | |||
| pleural effusion | 0/78 (0%) | 0/26 (0%) | 3/74 (4.1%) | |||
| pneumothorax | 5/78 (6.4%) | 0/26 (0%) | 15/74 (20.3%) | |||
| pulmonary hypertension | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| tracheal hemorrhage | 1/78 (1.3%) | 1/26 (3.8%) | 1/74 (1.4%) | |||
| upper respiratory infection | 8/78 (10.3%) | 11/26 (42.3%) | 12/74 (16.2%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| maculopapular rash | 0/78 (0%) | 0/26 (0%) | 1/74 (1.4%) | |||
| skin ulceration | 2/78 (2.6%) | 1/26 (3.8%) | 4/74 (5.4%) | |||
| soft tissue necrosis | 1/78 (1.3%) | 0/26 (0%) | 1/74 (1.4%) | |||
| subcutaneous emphysema | 1/78 (1.3%) | 3/26 (11.5%) | 4/74 (5.4%) | |||
| Vascular disorders | ||||||
| peripheral ischemia | 2/78 (2.6%) | 0/26 (0%) | 3/74 (4.1%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Bonnie Lonze, MD, PhD |
|---|---|
| Organization | NYU Langone Health |
| Phone | 212-263-3865 |
| bonnie.lonze@nyulangone.org |
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04343989
Other Study ID Numbers:
- 20-00392
- NCT04363502
- NCT04659772
First Posted:
Apr 14, 2020
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022