NCT04734873

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

Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Corvus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Covid-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-25
• Primary completion: 2021-08-18
• Completion: 2021-08-18
• First posted: 2021-02-02
• Last updated: 2022-09-21
• Results posted: 2022-08-23

Locations

91 sites across 12 countries: United States, Argentina, Brazil, Canada, Chile, Colombia, Germany, Italy, Mexico, Peru, Spain, Ukraine

Regulatory

• FDA-regulated drug study