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

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.

Condition

  • Covid-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04734873
Status
Terminated
Sponsor
Corvus Pharmaceuticals, Inc.