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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Covid-19

In brief

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.

Key facts

Study ID

NCT04734873

Run by

Corvus Pharmaceuticals, Inc.

People needed

46

Starts

2021-02-25

Expected to finish

2021-08-18

Last updated by the study team

2022-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• El Centro Regional Medical Center — El Centro, California, United States
• Sharp Grossmont Hospital — La Mesa, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Cambridge Medical Trials — Alexandria, Louisiana, United States
• MedPharmics — Metairie, Louisiana, United States
• Holy Cross Hospital — Silver Spring, Maryland, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Cape Fear Valley Medical Center — Fayetteville, North Carolina, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Clinica Zabala — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Clínica Adventista Belgrano — Estomba, Buenos Aires, Argentina
• Instituto Medico Platense — La Plata, Buenos Aires, Argentina
• Clinica Independencia — Munro, Buenos Aires, Argentina
• Instituto Médico Río Cuarto — Río Cuarto, Córdoba Province, Argentina
• Centro de Investigación Clínica - Clínica Viedma — Viedma, Río Negro Province, Argentina
• Centro Médico IPAM — Rosario, Santa Fe Province, Argentina
• Hospital Provincial Del Centenario — Rosario, Santa Fe Province, Argentina
• Clinica Mayo de U.M.C.B. S.R.L — San Miguel de Tucumán, Tucumán Province, Argentina
• Hospital de Clínicas Presidente Dr. Nicolás Avellaneda — San Miguel de Tucumán, Tucumán Province, Argentina
• Fundación Sanatorio Güemes — Buenos Aires, Argentina
• Sanatorio Finochietto — Buenos Aires, Argentina
• Sharp Chula Vista Medical Center — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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