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

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ClinicalTrials.gov Identifier: NCT04734873
Recruitment Status : Terminated (Sponsor decision. Not related to safety issues.)
First Posted : February 2, 2021
Results First Posted : August 23, 2022
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
Corvus Pharmaceuticals, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : February 25, 2021
Actual Primary Completion Date : August 18, 2021
Actual Study Completion Date : August 18, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC [ Time Frame: 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. Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC [ Time Frame: 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. Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC [ Time Frame: 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. Clinical improvement is defined as ≥ 2 points improvement in the 8-point ordinal scale.

  3. Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC [ Time Frame: During the 28 days after dosing ]
    Proportion of participants who died in each active arm compared to placebo arm


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734873


Locations
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Sponsors and Collaborators
Corvus Pharmaceuticals, Inc.
Investigators
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Study Chair: S. Mahabhashyam, MD, MPH Corvus Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Corvus Pharmaceuticals, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] March 23, 2021

More Information
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Responsible Party: Corvus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04734873    
Other Study ID Numbers: CPI-006-003
First Posted: February 2, 2021    Key Record Dates
Results First Posted: August 23, 2022
Last Update Posted: September 21, 2022
Last Verified: September 2022

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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:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases