Print

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.