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

Study results available
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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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04734873 on ClinicalTrials.gov