CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients

• Sponsor: Corvus Pharmaceuticals, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04734873
• Collaborator: (none)
• Enrollment: 46
• Locations: 91
• Arms: 3
• Actual Duration (Months): 5.7
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a phase 3, randomized, placebo controlled, double-blind, multicenter, stratified study of CPI-006 plus standard of care (SOC) versus placebo plus SOC in mild to moderately symptomatic hospitalized Covid-19 patients with the primary objective to compare the proportion of participants alive and respiratory failure free between CPI-006 plus SOC versus placebo plus SOC.

Condition or Disease	Intervention/Treatment	Phase
Covid-19	Drug: CPI-006 2 mg/kg + SOC; Drug: CPI-006 1 mg/kg + SOC; Drug: Placebo + SOC	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
• Actual Study Start Date: Feb 25, 2021
• Actual Primary Completion Date: Aug 18, 2021
• Actual Study Completion Date: Aug 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPI-006 (2 mg/kg) Plus Standard of Care Participants will receive a single dose of CPI-006 at 2 mg/kg up to a maximum dose of 200 mg intravenously on Day 1 plus standard of care.	Drug: CPI-006 2 mg/kg + SOC; IV CPI-006 2 mg/kg up to a maximum dose of 200 mg plus standard of care
Experimental: CPI-006 (1 mg/kg) Plus Standard of Care Participants will receive a single dose of CPI-006 at 1 mg/kg up to a maximum dose of 100 mg intravenously on Day 1 plus standard of care.	Drug: CPI-006 1 mg/kg + SOC; IV CPI-006 1 mg/kg up to a maximum dose of 100 mg plus standard of care
Placebo Comparator: Placebo Plus Standard of Care Participants will receive a single dose of placebo intravenously on Day 1 plus standard of care.	Drug: Placebo + SOC; IV placebo plus standard of care

Outcome Measures

Primary Outcome Measures

1. To Compare the Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC [During the 28 days after dosing]

   Proportion of participants who are alive and free from respiratory deterioration in each active arm compared to placebo arm as measured by the modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement in which: 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 requiring 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 extracorporeal membrane oxygenation; 8=Death.

Secondary Outcome Measures

1. To Compare the Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC [During the 28 days after dosing]

   Time to recovery after dosing in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 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 requiring 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 extracorporeal membrane oxygenation; 8=Death.

2. To Compare the Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC [During the 28 days after dosing]

   Time to clinical improvement in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 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 requiring 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 extracorporeal membrane oxygenation; 8=Death.

3. To Compare the Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC [During the 28 days after dosing]

   Proportion of participants who died in each active arm compared to placebo arm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Confirmed positive by polymerase chain reaction (PCR) or antigen test for SARS-CoV-2 with sample collection ≤ 10 days prior to randomization

• Covid-19 illness of any duration of symptoms

• Hospitalized for Covid-19 for ≤ 5 days with mild to moderate Covid-19 symptoms and meets criteria for either Category 4, Category 5, or Category 6 per 8-point ordinal scale

• Adequate organ function

• Participants of child-bearing age must agree to use adequate contraception for 6 weeks after study treatment administration

Exclusion Criteria:

• Signs of acute respiratory distress syndrome or respiratory failure necessitating mechanical ventilation at time of screening/randomization or anticipated need for mechanical ventilation

• History of severe chronic respiratory disease and requirement for long-term oxygen therapy

• Uncontrolled active systemic infection or hemodynamic instability requiring admission to an intensive care unit

• Malignant tumor receiving treatment, or other serious systemic diseases affecting life expectancy within 29 days of screening

• Receipt of cancer chemotherapy or immunomodulatory drugs during preceding 2 months (steroids for treatment of Covid-19 are acceptable)

• Convalescent plasma (CCP) or anti-SARS-CoV-2 monoclonal antibodies administered <24 hours prior to randomization. Must have recovered from any adverse events related to CCP treatment. Received chloroquine or hydroxychloroquine within last 7 days or during the study

• Current participation in other clinical trials including extended access programs

• Active deep vein thrombosis or pulmonary embolism within last 6 months

• Anticipated discharge from hospital or transfer to another hospital which is not a study site within 48 hours of admission

• Active uncontrolled co-morbid disease that may interfere with study conduct or interpretation of findings

• Known to be positive for HIV or positive test for chronic HBV infection or positive test for hepatitis C antibody

• Pregnancy or breast feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sharp Chula Vista Medical Center	Chula Vista	California	United States	91911
2	El Centro Regional Medical Center	El Centro	California	United States	92243
3	Sharp Grossmont Hospital	La Mesa	California	United States	91942
4	Torrance Memorial Medical Center	Torrance	California	United States	90505
5	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
6	Cambridge Medical Trials	Alexandria	Louisiana	United States	71301
7	MedPharmics	Metairie	Louisiana	United States	70006
8	Holy Cross Hospital	Silver Spring	Maryland	United States	20910
9	Mayo Clinic - Rochester	Rochester	Minnesota	United States	55905
10	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
11	Cape Fear Valley Medical Center	Fayetteville	North Carolina	United States	28304
12	Lehigh Valley Health Network	Allentown	Pennsylvania	United States	18103
13	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
14	Clinica Zabala	Ciudad Autónoma de Buenos Aires	Buenos Aires	Argentina
15	Clínica Adventista Belgrano	Estomba	Buenos Aires	Argentina
16	Instituto Medico Platense	La Plata	Buenos Aires	Argentina
17	Clinica Independencia	Munro	Buenos Aires	Argentina
18	Instituto Médico Río Cuarto	Río Cuarto	Córdoba	Argentina
19	Centro de Investigación Clínica - Clínica Viedma	Viedma	Río Negro	Argentina
20	Centro Médico IPAM	Rosario	Santa Fe	Argentina
21	Hospital Provincial Del Centenario	Rosario	Santa Fe	Argentina
22	Clinica Mayo de U.M.C.B. S.R.L	San Miguel de Tucumán	Tucumán	Argentina
23	Hospital de Clínicas Presidente Dr. Nicolás Avellaneda	San Miguel De Tucumán	Tucumán	Argentina
24	Fundación Sanatorio Güemes	Ciudad Autónoma de Buenos Aires		Argentina
25	Sanatorio Finochietto	Ciudad Autónoma de Buenos Aires		Argentina
26	Hospital Rawson	Córdoba		Argentina
27	Hospital Vera Cruz	Belo Horizonte	Minas Gerais	Brazil
28	Hospital Agamenon Magalhães	Recife	Pernambuco	Brazil
29	Santa Casa de Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil
30	Hospital Dia do Pulmão	Blumenau	Santa Catarina	Brazil
31	Clínica Supera	Chapecó	Santa Catarina	Brazil
32	Centro Hospitalar Nossa Saúde	Curitiba		Brazil
33	Universidade Municipal São Caetano do Sul	São Caetano do Sul		Brazil
34	Conjunto Hospitalar do Mandaqui	São Paulo		Brazil
35	Hospital Anchieta	São Paulo		Brazil
36	Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto	São Paulo		Brazil
37	Hospital E Maternidade Celso Pierro PUCCAMP	São Paulo		Brazil
38	Universidade Federal Do Espirito Santo - Hospital Universitário Cassiano Antônio de Moraes - HUCAM	Vitória		Brazil
39	Toronto General Hospital	Toronto	Ontario	Canada
40	Hôpital Maisonneuve-Rosemont	Montréal	Quebec	Canada	H1T 2M4
41	Hospital Base de Osorno	Concepción		Chile
42	Clinica Vespucio	La Florida		Chile
43	Research Network Consulting	Linares		Chile
44	Clínica Dávila Y Servicios Médicos SA	Santiago		Chile
45	Rodrigo Botero S.A.S	Medellín	Antioquia	Colombia
46	Fundacion Santa Fe de Bogota	Bogotá	Cundinamarca	Colombia
47	Clínica Universidad De la Sabana	Chía	Cundinamarca	Colombia
48	Fundacion Centro de Excelencia en Enfermedades Cronicas No Transmisibles	Monteria	Córdoba	Colombia
49	Clínica de la Mujer S.A.S.	Bogotá		Colombia
50	Hospital Universitario Clinica San Rafael	Bogotá		Colombia
51	Fundacion Hospitalaria San Vicente de Paul	Medellín		Colombia
52	Promotora Medica Las Américas S.A- Clínica Las Américas	Medellín		Colombia
53	Fundación Valle Del Lili	Santiago de Cali		Colombia
54	Medizinische Hochschule Hannover	Hannover	Niedersachsen	Germany
55	Azienda Ospedaliera Cotugno	Napoli	Campania	Italy
56	ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco	Milano	Lombardia	Italy
57	ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda	Milano	Lombardia	Italy
58	ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo	Milano	Lombardia	Italy
59	Ospedale San Raffaele S.r.l.	Milano	Lombardia	Italy
60	ASST di Monza - Azienda Ospedaliera San Gerardo	Monza	Lombardia	Italy
61	Fondazione IRCCS Policlinico San Matteo di Pavia	Pavia	Lombardia	Italy
62	ASST della Valle Olona - Azienda Ospedaliera Ospedale Di Circolo Di Busto Arsizio	Busto Arsizio		Italy
63	Hospital Civil Fray Antonio Alcalde	Guadalajara	Jalisco	Mexico
64	Hospital Universitario Dr. Jose Eleuterio González	Monterrey	Nuevo Leon	Mexico
65	Hospital Civil de Culiacán	Culiacán	Sinaloa	Mexico
66	Hospital General de Culiacán	Culiacán	Sinaloa	Mexico
67	Hospital Nacional Sergio E. Bernales	Comas	Lima	Peru
68	Hospital Chancay y Servicios Basicos de Salud	Huaral	Lima	Peru
69	Hospital Central Fuerza Aérea del Perú	Miraflores	Lima	Peru
70	Hospital María Auxiliadora	San Juan De Miraflores	Lima	Peru
71	Clínica Providencia	San Miguel	Lima	Peru
72	Clínica San Pablo	Santiago De Surco	Lima	Peru
73	Hospital Alberto Sabogal Sologuren	Callao		Peru
74	Hospital Nacional Adolfo Guevara Velasco Essalud	Cusco		Peru
75	Hospital Militar Central	Lima		Peru
76	Hospital Nacional Guillermo Almenara Irigoyen	Lima		Peru
77	Hospital Costa del Sol	Marbella	Málaga	Spain
78	Complejo Hospitalario de Navarra	Pamplona	Navarra	Spain
79	Hospital del Mar	Barcelona		Spain
80	Hospital General Universitario de Guadalajara	Guadalajara		Spain
81	Complejo Asistencial Universitario de Salamanca - H. Clinico	Salamanca		Spain
82	Hospital Universitario A Coruña	Santiago de Compostela		Spain
83	Municipal Institution City Clinical Hospital #6 of Dnipropetrovsk Regional Council	Dnipro	Dnipropetrovs'ka Oblast	Ukraine
84	Kharkiv Regional Clinical Infectious Diseases Hospital	Kharkiv	Kharkivs'ka Oblast	Ukraine
85	Poltava Regional Clinical Infectious Hospital	Poltava	Poltavs'ka Oblast	Ukraine
86	Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1	Vinnytsya	Vinnytsia Oblast	Ukraine
87	Municipal enterprise Volyn Regional Clinical Hospital of Volyn Regional Council	Lutsk	Volyn Oblast	Ukraine
88	MNPE City Hospital No. 6 of Zaporizhzhia City Council	Zaporizhzhia	Zaporiz'ka Oblast	Ukraine
89	Municipal Institution City Hospital #7	Zhaporizhzhya	Zaporiz'ka Oblast	Ukraine
90	CNPE City Clinical Hospital #3 of Chernivtsi City Council	Chernivtsi		Ukraine
91	Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council	Dnipro		Ukraine

Sponsors and Collaborators

• Corvus Pharmaceuticals, Inc.

Investigators

• Study Chair: S. Mahabhashyam, MD, MPH, Corvus Pharmaceuticals

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 23, 2021

More Information

Publications

None provided.

• Responsible Party: Corvus Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT04734873
• Other Study ID Numbers: CPI-006-003
• First Posted: Feb 2, 2021
• Last Update Posted: Aug 23, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Corvus Pharmaceuticals, Inc.: SARS-CoV-2; Covid; Coronavirus; Covid19; COVID-19
• Additional relevant MeSH terms: COVID-19

Study Results

Participant Flow

Recruitment Details	46 participants were screened and 42 were randomized. Of the 42 participants randomized, only 40 received the treatment assigned at randomization (2 were randomized but withdrew consent prior to receiving study treatment).

Arm/Group Title	Treatment A	Treatment B	Treatment C
Arm/Group Description	IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	IV placebo on Day 1 plus standard of care
Period Title: Overall Study
STARTED	16	14	12
COMPLETED	14	11	9
NOT COMPLETED	2	3	3

Baseline Characteristics

Arm/Group Title	Treatment A	Treatment B	Treatment C	Total
Arm/Group Description	IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	IV placebo on Day 1 plus standard of care	Total of all reporting groups
Overall Participants	16	14	12	42
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	13 81.3%	13 92.9%	12 100%	38 90.5%
>=65 years	3 18.8%	1 7.1%	0 0%	4 9.5%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	56.5	53.0	55.0	56.0
Sex: Female, Male (Count of Participants)
Female	6 37.5%	3 21.4%	9 75%	18 42.9%
Male	10 62.5%	11 78.6%	3 25%	24 57.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 37.5%	3 21.4%	3 25%	12 28.6%
Not Hispanic or Latino	8 50%	11 78.6%	8 66.7%	27 64.3%
Unknown or Not Reported	2 12.5%	0 0%	1 8.3%	3 7.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	1 7.1%	1 8.3%	2 4.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	2 12.5%	2 14.3%	2 16.7%	6 14.3%
White	13 81.3%	11 78.6%	9 75%	33 78.6%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 6.3%	0 0%	0 0%	1 2.4%
Region of Enrollment (Count of Participants)
United States	16 100%	13 92.9%	12 100%	41 97.6%
Spain	0 0%	1 7.1%	0 0%	1 2.4%
8-point Ordinal Scale Assessment (Count of Participants)
4	0 0%	3 21.4%	2 16.7%	5 11.9%
5	7 43.8%	10 71.4%	7 58.3%	24 57.1%
6	9 56.3%	1 7.1%	3 25%	13 31%

Outcome Measures

1. Primary Outcome

Title	To Compare the Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC
Description	Proportion of participants who are alive and free from respiratory deterioration in each active arm compared to placebo arm as measured by the modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement in which: 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 requiring 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 extracorporeal membrane oxygenation; 8=Death.
Time Frame	During the 28 days after dosing

Outcome Measure Data

Analysis Population Description

All participants who received any amount of study drug (CPI-006 or placebo) and have post-baseline efficacy assessment based on the 8-point ordinal scale.

Arm/Group Title	Treatment A	Treatment B	Treatment C
Arm/Group Description	IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	IV placebo on Day 1 plus standard of care
Measure Participants	15	14	11
Count of Participants [Participants]	14 87.5%	12 85.7%	9 75%

2. Secondary Outcome

Title	To Compare the Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC
Description	Time to recovery after dosing in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 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 requiring 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 extracorporeal membrane oxygenation; 8=Death.
Time Frame	During the 28 days after dosing

Outcome Measure Data

Analysis Population Description

All participants who received any amount of study drug (CPI-006 or placebo) and recovered during the 28 days after dosing.

Arm/Group Title	Treatment A	Treatment B	Treatment C
Arm/Group Description	IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	IV placebo on Day 1 plus standard of care
Measure Participants	14	14	10
Median (95% Confidence Interval) [days]	6.0	4.5	7.0

3. Secondary Outcome

Title	To Compare the Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC
Description	Time to clinical improvement in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 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 requiring 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 extracorporeal membrane oxygenation; 8=Death.
Time Frame	During the 28 days after dosing

Outcome Measure Data

Analysis Population Description

All participants who received any amount of study drug (CPI-006 or placebo) and achieved clinical improvement during the 28 days after dosing.

Arm/Group Title	Treatment A	Treatment B	Treatment C
Arm/Group Description	IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	IV placebo on Day 1 plus standard of care
Measure Participants	14	14	11
Median (95% Confidence Interval) [days]	6.0	4.5	7.0

4. Secondary Outcome

Title	To Compare the Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC
Description	Proportion of participants who died in each active arm compared to placebo arm
Time Frame	During the 28 days after dosing

Outcome Measure Data

Analysis Population Description

All participants who received any amount of study drug (CPI-006 or placebo).

Arm/Group Title	Treatment A	Treatment B	Treatment C
Arm/Group Description	IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	IV placebo on Day 1 plus standard of care
Measure Participants	15	14	11
Count of Participants [Participants]	0 0%	0 0%	0 0%

Adverse Events

Time Frame	From initiation of study treatment through study Day 28 (4 weeks)
Adverse Event Reporting Description	The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Arm/Group Title	Treatment A		Treatment B		Treatment C
Arm/Group Description	IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care		IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care		IV placebo on Day 1 plus standard of care
All Cause Mortality
	Treatment A		Treatment B		Treatment C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/14 (0%)		0/11 (0%)
Serious Adverse Events
	Treatment A		Treatment B		Treatment C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/14 (0%)		2/11 (18.2%)
Psychiatric disorders
Substance-induced psychotic disorder	0/15 (0%)		0/14 (0%)		1/11 (9.1%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	0/15 (0%)		0/14 (0%)		1/11 (9.1%)
Other (Not Including Serious) Adverse Events
	Treatment A		Treatment B		Treatment C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/15 (33.3%)		2/14 (14.3%)		3/11 (27.3%)
Eye disorders
Myopia	0/15 (0%)		1/14 (7.1%)		0/11 (0%)
Visual impairment	0/15 (0%)		0/14 (0%)		1/11 (9.1%)
Gastrointestinal disorders
Abdominal hernia	1/15 (6.7%)		0/14 (0%)		0/11 (0%)
Abdominal pain upper	0/15 (0%)		0/14 (0%)		1/11 (9.1%)
Dry mouth	0/15 (0%)		1/14 (7.1%)		0/11 (0%)
Hepatobiliary disorders
Hepatomegaly	1/15 (6.7%)		0/14 (0%)		0/11 (0%)
Infections and infestations
Diverticulitis	1/15 (6.7%)		0/14 (0%)		0/11 (0%)
Pneumonia escherichia	1/15 (6.7%)		0/14 (0%)		0/11 (0%)
Pneumonia klebsiella	1/15 (6.7%)		0/14 (0%)		0/11 (0%)
Skin candida	1/15 (6.7%)		0/14 (0%)		0/11 (0%)
Metabolism and nutrition disorders
Hypokalaemia	1/15 (6.7%)		0/14 (0%)		0/11 (0%)
Musculoskeletal and connective tissue disorders
Muscle spasms	0/15 (0%)		1/14 (7.1%)		0/11 (0%)
Nervous system disorders
Amnesia	1/15 (6.7%)		0/14 (0%)		0/11 (0%)
Dizziness	1/15 (6.7%)		0/14 (0%)		0/11 (0%)
Dyskinesia	1/15 (6.7%)		0/14 (0%)		0/11 (0%)
Headache	0/15 (0%)		0/14 (0%)		1/11 (9.1%)
Hypoaesthesia	0/15 (0%)		1/14 (7.1%)		0/11 (0%)
Presyncope	0/15 (0%)		1/14 (7.1%)		0/11 (0%)
Syncope	0/15 (0%)		0/14 (0%)		1/11 (9.1%)
Tremor	0/15 (0%)		1/14 (7.1%)		0/11 (0%)
Psychiatric disorders
Insomnia	0/15 (0%)		1/14 (7.1%)		0/11 (0%)
Substance-induced psychotic disorder	0/15 (0%)		0/14 (0%)		1/11 (9.1%)
Renal and urinary disorders
Pollakiuria	0/15 (0%)		1/14 (7.1%)		0/11 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	0/15 (0%)		0/14 (0%)		1/11 (9.1%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	0/15 (0%)		1/14 (7.1%)		0/11 (0%)
Rash	0/15 (0%)		1/14 (7.1%)		0/11 (0%)

Limitations/Caveats

The study was terminated due to enrollment difficulties and, as a result, some of the originally planned efficacy analyses could not be performed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Investigators are free to publish/present study results from their site upon occurrence of one of either: a multi-center publication, no publication is submitted within 18 months after end of study, or sponsor confirms there will be no publication. Investigators must provide the sponsor all draft publications for review at least 30 days prior to submission. Sponsor may request to defer publication and/or delete sponsor's confidential information to allow the sponsor to preserve its IP rights.