CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
NCT04734873 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2022-09-21
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 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.
Conditions
Interventions
- 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
- 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
- DRUG
-
Placebo + SOC
IV placebo plus standard of care
Sponsors & Collaborators
-
Corvus Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
S. Mahabhashyam, MD, MPH · Corvus Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-25
- Primary Completion
- 2021-08-18
- Completion
- 2021-08-18
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Brazil
- Canada
- Chile
- Colombia
- Germany
- Italy
- Mexico
- Peru
- Spain
- Ukraine
Study Locations
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