CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
- Conditions
- Covid-19
- Interventions
- Drug: CPI-006 2 mg/kg + SOCDrug: CPI-006 1 mg/kg + SOCDrug: Placebo + SOC
- Registration Number
- NCT04734873
- Lead Sponsor
- Corvus Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CPI-006 (2 mg/kg) Plus Standard of Care CPI-006 2 mg/kg + SOC Participants will receive a single dose of CPI-006 at 2 mg/kg up to a maximum dose of 200 mg intravenously on Day 1 plus standard of care. CPI-006 (1 mg/kg) Plus Standard of Care CPI-006 1 mg/kg + SOC Participants will receive a single dose of CPI-006 at 1 mg/kg up to a maximum dose of 100 mg intravenously on Day 1 plus standard of care. Placebo Plus Standard of Care Placebo + SOC Participants will receive a single dose of placebo intravenously on Day 1 plus standard of care.
- Primary Outcome Measures
Name Time Method Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC During the 28 days after dosing Proportion of participants who are alive and free from respiratory deterioration in each active arm compared to placebo arm as measured by the modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death.
- Secondary Outcome Measures
Name Time Method Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC During the 28 days after dosing Time to recovery after dosing in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death.
Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC During the 28 days after dosing Time to clinical improvement in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death. Clinical improvement is defined as ≥ 2 points improvement in the 8-point ordinal scale.
Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC During the 28 days after dosing Proportion of participants who died in each active arm compared to placebo arm
Trial Locations
- Locations (91)
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Hospital Central Fuerza Aérea del Perú
🇵🇪Miraflores, Lima, Peru
Hospital María Auxiliadora
🇵🇪San Juan De Miraflores, Lima, Peru
Sharp Chula Vista Medical Center
🇺🇸Chula Vista, California, United States
Centro Hospitalar Nossa Saúde
🇧🇷Curitiba, Brazil
Poltava Regional Clinical Infectious Hospital
🇺🇦Poltava, Poltavs'ka Oblast, Ukraine
CNPE City Clinical Hospital #3 of Chernivtsi City Council
🇺🇦Chernivtsi, Ukraine
Complejo Asistencial Universitario de Salamanca - H. Clinico
🇪🇸Salamanca, Spain
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Hospital Anchieta
🇧🇷São Paulo, Brazil
Hôpital Maisonneuve-Rosemont
🇨🇦Montréal, Quebec, Canada
Conjunto Hospitalar do Mandaqui
🇧🇷São Paulo, Brazil
Research Network Consulting
🇨🇱Linares, Chile
Hospital Nacional Sergio E. Bernales
🇵🇪Comas, Lima, Peru
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
🇧🇷São Paulo, Brazil
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
🇮🇹Milano, Lombardia, Italy
Ospedale San Raffaele S.r.l.
🇮🇹Milano, Lombardia, Italy
Universidade Federal Do Espirito Santo - Hospital Universitário Cassiano Antônio de Moraes - HUCAM
🇧🇷Vitória, Brazil
Universidade Municipal São Caetano do Sul
🇧🇷São Caetano do Sul, Brazil
Rodrigo Botero S.A.S
🇨🇴Medellín, Antioquia, Colombia
ASST di Monza - Azienda Ospedaliera San Gerardo
🇮🇹Monza, Lombardia, Italy
ASST della Valle Olona - Azienda Ospedaliera Ospedale Di Circolo Di Busto Arsizio
🇮🇹Busto Arsizio, Italy
Clínica de la Mujer S.A.S.
🇨🇴Bogotá, Colombia
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
🇮🇹Pavia, Lombardia, Italy
Hospital E Maternidade Celso Pierro PUCCAMP
🇧🇷São Paulo, Brazil
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Hospital General Universitario de Guadalajara
🇪🇸Guadalajara, Spain
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
🇮🇹Milano, Lombardia, Italy
MNPE City Hospital No. 6 of Zaporizhzhia City Council
🇺🇦Zaporizhzhia, Zaporiz'ka Oblast, Ukraine
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council
🇺🇦Dnipro, Ukraine
Municipal Institution City Clinical Hospital #6 of Dnipropetrovsk Regional Council
🇺🇦Dnipro, Dnipropetrovs'ka Oblast, Ukraine
Municipal Institution City Hospital #7
🇺🇦Zhaporizhzhya, Zaporiz'ka Oblast, Ukraine
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Civil de Culiacán
🇲🇽Culiacán, Sinaloa, Mexico
Hospital General de Culiacán
🇲🇽Culiacán, Sinaloa, Mexico
Hospital Vera Cruz
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Clinica Zabala
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Clínica Dávila Y Servicios Médicos SA
🇨🇱Santiago, Chile
Fundacion Hospitalaria San Vicente de Paul
🇨🇴Medellín, Colombia
Centro Médico IPAM
🇦🇷Rosario, Santa Fe, Argentina
Hospital Civil Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
Clínica Universidad De la Sabana
🇨🇴Chía, Cundinamarca, Colombia
Clinica Vespucio
🇨🇱La Florida, Chile
Fundacion Santa Fe de Bogota
🇨🇴Bogotá, Cundinamarca, Colombia
Clinica Mayo de U.M.C.B. S.R.L
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Hospital Universitario Clinica San Rafael
🇨🇴Bogotá, Colombia
Promotora Medica Las Américas S.A- Clínica Las Américas
🇨🇴Medellín, Colombia
Fundación Valle Del Lili
🇨🇴Santiago de Cali, Colombia
Clínica San Pablo
🇵🇪Santiago De Surco, Lima, Peru
Hospital Alberto Sabogal Sologuren
🇵🇪Callao, Peru
Fundacion Centro de Excelencia en Enfermedades Cronicas No Transmisibles
🇨🇴Monteria, Córdoba, Colombia
Hospital Chancay y Servicios Basicos de Salud
🇵🇪Huaral, Lima, Peru
Hospital Universitario Dr. Jose Eleuterio González
🇲🇽Monterrey, Nuevo Leon, Mexico
Hospital Nacional Adolfo Guevara Velasco Essalud
🇵🇪Cusco, Peru
Hospital Nacional Guillermo Almenara Irigoyen
🇵🇪Lima, Peru
Hospital Costa del Sol
🇪🇸Marbella, Málaga, Spain
MedPharmics
🇺🇸Metairie, Louisiana, United States
El Centro Regional Medical Center
🇺🇸El Centro, California, United States
Sharp Grossmont Hospital
🇺🇸La Mesa, California, United States
Cambridge Medical Trials
🇺🇸Alexandria, Louisiana, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, 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 Independencia
🇦🇷Munro, Buenos Aires, Argentina
Instituto Medico Platense
🇦🇷La Plata, Buenos Aires, Argentina
Clínica Adventista Belgrano
🇦🇷Estomba, Buenos Aires, Argentina
Instituto Médico Río Cuarto
🇦🇷Río Cuarto, Córdoba, Argentina
Hospital Provincial Del Centenario
🇦🇷Rosario, Santa Fe, Argentina
Centro de Investigación Clínica - Clínica Viedma
🇦🇷Viedma, Río Negro, Argentina
Hospital de Clínicas Presidente Dr. Nicolás Avellaneda
🇦🇷San Miguel De Tucumán, Tucumán, Argentina
Hospital Rawson
🇦🇷Córdoba, Argentina
Fundación Sanatorio Güemes
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Sanatorio Finochietto
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Hospital Agamenon Magalhães
🇧🇷Recife, Pernambuco, Brazil
Santa Casa de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Dia do Pulmão
🇧🇷Blumenau, Santa Catarina, Brazil
Clínica Supera
🇧🇷Chapecó, Santa Catarina, Brazil
Hospital Base de Osorno
🇨🇱Concepción, Chile
Azienda Ospedaliera Cotugno
🇮🇹Napoli, Campania, Italy
Clínica Providencia
🇵🇪San Miguel, Lima, Peru
Hospital Universitario A Coruña
🇪🇸Santiago de Compostela, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Kharkiv Regional Clinical Infectious Diseases Hospital
🇺🇦Kharkiv, Kharkivs'ka Oblast, Ukraine
Municipal enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
🇺🇦Lutsk, Volyn Oblast, Ukraine
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
🇺🇦Vinnytsya, Vinnytsia Oblast, Ukraine
Hospital Militar Central
🇵🇪Lima, Peru