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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04734873
• Other study ID #: CPI-006-003
• Status: Terminated
• Phase: Phase 3
• Start date: February 25, 2021
• Est. completion date: August 18, 2021

Study information

• Verified date: September 2022
• Source: Corvus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: August 18, 2021
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Covid-19

Intervention

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
• CPI-006 1 mg/kg + SOC
IV CPI-006 1 mg/kg up to a maximum dose of 100 mg plus standard of care
• Placebo + SOC
IV placebo plus standard of care

Locations

Country	Name	City	State
Argentina	Clinica Zabala	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Fundación Sanatorio Güemes	Ciudad Autónoma de Buenos Aires
Argentina	Sanatorio Finochietto	Ciudad Autónoma de Buenos Aires
Argentina	Hospital Rawson	Córdoba
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
Argentina	Centro Médico IPAM	Rosario	Santa Fe
Argentina	Hospital Provincial Del Centenario	Rosario	Santa Fe
Argentina	Clinica Mayo de U.M.C.B. S.R.L	San Miguel de Tucumán	Tucumán
Argentina	Hospital de Clínicas Presidente Dr. Nicolás Avellaneda	San Miguel De Tucumán	Tucumán
Argentina	Centro de Investigación Clínica - Clínica Viedma	Viedma	Río Negro
Brazil	Hospital Vera Cruz	Belo Horizonte	Minas Gerais
Brazil	Hospital Dia do Pulmão	Blumenau	Santa Catarina
Brazil	Clínica Supera	Chapecó	Santa Catarina
Brazil	Centro Hospitalar Nossa Saúde	Curitiba
Brazil	Santa Casa de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Agamenon Magalhães	Recife	Pernambuco
Brazil	Universidade Municipal São Caetano do Sul	São Caetano do Sul
Brazil	Conjunto Hospitalar do Mandaqui	São Paulo
Brazil	Hospital Anchieta	São Paulo
Brazil	Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto	São Paulo
Brazil	Hospital E Maternidade Celso Pierro PUCCAMP	São Paulo
Brazil	Universidade Federal Do Espirito Santo - Hospital Universitário Cassiano Antônio de Moraes - HUCAM	Vitória
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Chile	Hospital Base de Osorno	Concepción
Chile	Clinica Vespucio	La Florida
Chile	Research Network Consulting	Linares
Chile	Clínica Dávila Y Servicios Médicos SA	Santiago
Colombia	Clínica de la Mujer S.A.S.	Bogotá
Colombia	Fundacion Santa Fe de Bogota	Bogotá	Cundinamarca
Colombia	Hospital Universitario Clinica San Rafael	Bogotá
Colombia	Clínica Universidad De la Sabana	Chía	Cundinamarca
Colombia	Fundacion Hospitalaria San Vicente de Paul	Medellín
Colombia	Promotora Medica Las Américas S.A- Clínica Las Américas	Medellín
Colombia	Rodrigo Botero S.A.S	Medellín	Antioquia
Colombia	Fundacion Centro de Excelencia en Enfermedades Cronicas No Transmisibles	Monteria	Córdoba
Colombia	Fundación Valle Del Lili	Santiago de Cali
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Italy	ASST della Valle Olona - Azienda Ospedaliera Ospedale Di Circolo Di Busto Arsizio	Busto Arsizio
Italy	ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco	Milano	Lombardia
Italy	ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda	Milano	Lombardia
Italy	ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo	Milano	Lombardia
Italy	Ospedale San Raffaele S.r.l.	Milano	Lombardia
Italy	ASST di Monza - Azienda Ospedaliera San Gerardo	Monza	Lombardia
Italy	Azienda Ospedaliera Cotugno	Napoli	Campania
Italy	Fondazione IRCCS Policlinico San Matteo di Pavia	Pavia	Lombardia
Mexico	Hospital Civil de Culiacán	Culiacán	Sinaloa
Mexico	Hospital General de Culiacán	Culiacán	Sinaloa
Mexico	Hospital Civil Fray Antonio Alcalde	Guadalajara	Jalisco
Mexico	Hospital Universitario Dr. Jose Eleuterio González	Monterrey	Nuevo Leon
Peru	Hospital Alberto Sabogal Sologuren	Callao
Peru	Hospital Nacional Sergio E. Bernales	Comas	Lima
Peru	Hospital Nacional Adolfo Guevara Velasco Essalud	Cusco
Peru	Hospital Chancay y Servicios Basicos de Salud	Huaral	Lima
Peru	Hospital Militar Central	Lima
Peru	Hospital Nacional Guillermo Almenara Irigoyen	Lima
Peru	Hospital Central Fuerza Aérea del Perú	Miraflores	Lima
Peru	Hospital María Auxiliadora	San Juan De Miraflores	Lima
Peru	Clínica Providencia	San Miguel	Lima
Peru	Clínica San Pablo	Santiago De Surco	Lima
Spain	Hospital del Mar	Barcelona
Spain	Hospital General Universitario de Guadalajara	Guadalajara
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Complejo Asistencial Universitario de Salamanca - H. Clinico	Salamanca
Spain	Hospital Universitario A Coruña	Santiago de Compostela
Ukraine	CNPE City Clinical Hospital #3 of Chernivtsi City Council	Chernivtsi
Ukraine	Municipal Institution City Clinical Hospital #6 of Dnipropetrovsk Regional Council	Dnipro	Dnipropetrovs'ka Oblast
Ukraine	Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council	Dnipro
Ukraine	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	Poltava Regional Clinical Infectious Hospital	Poltava	Poltavs'ka Oblast
Ukraine	Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1	Vinnytsya	Vinnytsia Oblast
Ukraine	MNPE City Hospital No. 6 of Zaporizhzhia City Council	Zaporizhzhia	Zaporiz'ka Oblast
Ukraine	Municipal Institution City Hospital #7	Zhaporizhzhya	Zaporiz'ka Oblast
United States	Cambridge Medical Trials	Alexandria	Louisiana
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Sharp Chula Vista Medical Center	Chula Vista	California
United States	El Centro Regional Medical Center	El Centro	California
United States	Cape Fear Valley Medical Center	Fayetteville	North Carolina
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Sharp Grossmont Hospital	La Mesa	California
United States	MedPharmics	Metairie	Louisiana
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Torrance Memorial Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Corvus Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Chile,  Colombia,  Germany,  Italy,  Mexico,  Peru,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC	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.	During the 28 days after dosing
Secondary	Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC	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.	During the 28 days after dosing
Secondary	Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC	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.	During the 28 days after dosing
Secondary	Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC	Proportion of participants who died in each active arm compared to placebo arm	During the 28 days after dosing