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

• Status: Terminated
• Trial end date: 2021-08-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corvus Pharmaceuticals, Inc.

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