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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 : Recruiting
First Posted : February 2, 2021
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Corvus Pharmaceuticals, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 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
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : January 30, 2022

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




Primary Outcome Measures :
  1. To compare the 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 measured by the 8-point ordinal scale


Secondary Outcome Measures :
  1. To compare the 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 measured by the 8-point ordinal scale

  2. To compare the 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 measured by the 8-point ordinal scale

  3. To compare the 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



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Corvus Clinical Trials 650-900-4520 clinicaltrials@corvuspharma.com

Locations
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Sponsors and Collaborators
Corvus Pharmaceuticals, Inc.
Investigators
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Study Chair: S. Mahabhashyam, MD, MPH Corvus Pharmaceuticals
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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
Last Update Posted: May 4, 2021
Last Verified: May 2021

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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