Philadelphia, Pennsylvania 19140

  • 19

Purpose:

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.


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


NCT ID:

NCT04734873


Primary Contact:

Study Chair
S. Mahabhashyam, MD, MPH
Corvus Pharmaceuticals

Corvus Clinical Trials
Phone: 650-900-4520
Email: clinicaltrials@corvuspharma.com


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19140
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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