COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04734873

Corvus Clinical Trials

clinicaltrials@corvuspharma.com

2021-02-02

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

- 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) - 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 - 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 - pregnancy or breast feeding

3

Corvus Pharmaceuticals, Inc.

18

100

Argentina;Brazil;Canada;Chile;Colombia;Germany;Italy;Mexico;Peru;Spain;Ukraine;United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

46

Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC

None

Phase 3

[{"arm_notes": "1 mg/kg ", "treatment_id": 353, "treatment_name": "Mopadulimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "2 mg/kg ", "treatment_id": 353, "treatment_name": "Mopadulimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]