Status:
TERMINATED
CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
Lead Sponsor:
Corvus Pharmaceuticals, Inc.
Conditions:
Covid-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hospital...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04734873
Start Date
February 25 2021
End Date
August 18 2021
Last Update
September 21 2022
Active Locations (91)
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1
Sharp Chula Vista Medical Center
Chula Vista, California, United States, 91911
2
El Centro Regional Medical Center
El Centro, California, United States, 92243
3
Sharp Grossmont Hospital
La Mesa, California, United States, 91942
4
Torrance Memorial Medical Center
Torrance, California, United States, 90505