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

Corvus Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Covid-19

Treatments: Drug: CPI-006 1 mg/kg + SOC; Drug: Placebo + SOC; Drug: CPI-006 2 mg/kg + SOC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04734873

CPI-006-003

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 3 patient groups, including a placebo group

CPI-006 (2 mg/kg) Plus Standard of Care

Experimental group

Description:

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.

Treatment:

Drug: CPI-006 2 mg/kg + SOC

CPI-006 (1 mg/kg) Plus Standard of Care

Experimental group

Description:

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.

Treatment:

Drug: CPI-006 1 mg/kg + SOC

Placebo Plus Standard of Care

Placebo Comparator group

Description:

Participants will receive a single dose of placebo intravenously on Day 1 plus standard of care.

Treatment:

Drug: Placebo + SOC