Clinical trial NCT04734873: CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Covid-19
Keywords: SARS-CoV-2
Covid
Coronavirus
Covid19
COVID-19
Lead sponsor: Corvus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC
timeFrame: During the 28 days after dosing
Secondary outcomes:
measure: Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC
timeFrame: During the 28 days after dosing
measure: Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC
timeFrame: During the 28 days after dosing
measure: Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC
timeFrame: During the 28 days after dosing
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Sharp Chula Vista Medical Center
state: California
city: El Centro
country: United States
facility: El Centro Regional Medical Center
state: California
city: La Mesa
country: United States
facility: Sharp Grossmont Hospital
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Alexandria
country: United States
facility: Cambridge Medical Trials
state: Louisiana
city: Metairie
country: United States
facility: MedPharmics
state: Louisiana
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Fayetteville
country: United States
facility: Cape Fear Valley Medical Center
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Clinica Zabala
state: Buenos Aires
city: Estomba
country: Argentina
facility: Clínica Adventista Belgrano
state: Buenos Aires
city: La Plata
country: Argentina
facility: Instituto Medico Platense
state: Buenos Aires
city: Munro
country: Argentina
facility: Clinica Independencia
state: Buenos Aires
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Córdoba
city: Viedma
country: Argentina
facility: Centro de Investigación Clínica - Clínica Viedma
state: Río Negro
city: Rosario
country: Argentina
facility: Centro Médico IPAM
state: Santa Fe
city: Rosario
country: Argentina
facility: Hospital Provincial Del Centenario
state: Santa Fe
city: San Miguel de Tucumán
country: Argentina
facility: Clinica Mayo de U.M.C.B. S.R.L
state: Tucumán
city: San Miguel De Tucumán
country: Argentina
facility: Hospital de Clínicas Presidente Dr. Nicolás Avellaneda
state: Tucumán
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Fundación Sanatorio Güemes
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Sanatorio Finochietto
city: Córdoba
country: Argentina
facility: Hospital Rawson
city: Belo Horizonte
country: Brazil
facility: Hospital Vera Cruz
state: Minas Gerais
city: Recife
country: Brazil
facility: Hospital Agamenon Magalhães
state: Pernambuco
city: Porto Alegre
country: Brazil
facility: Santa Casa de Porto Alegre
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Hospital Dia do Pulmão
state: Santa Catarina
city: Chapecó
country: Brazil
facility: Clínica Supera
state: Santa Catarina
city: Curitiba
country: Brazil
facility: Centro Hospitalar Nossa Saúde
city: São Caetano do Sul
country: Brazil
facility: Universidade Municipal São Caetano do Sul
city: São Paulo
country: Brazil
facility: Conjunto Hospitalar do Mandaqui
city: São Paulo
country: Brazil
facility: Hospital Anchieta
city: São Paulo
country: Brazil
facility: Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
city: São Paulo
country: Brazil
facility: Hospital E Maternidade Celso Pierro PUCCAMP
city: Vitória
country: Brazil
facility: Universidade Federal Do Espirito Santo - Hospital Universitário Cassiano Antônio de Moraes - HUCAM
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Concepción
country: Chile
facility: Hospital Base de Osorno
city: La Florida
country: Chile
facility: Clinica Vespucio
city: Linares
country: Chile
facility: Research Network Consulting
city: Santiago
country: Chile
facility: Clínica Dávila Y Servicios Médicos SA
city: Medellín
country: Colombia
facility: Rodrigo Botero S.A.S
state: Antioquia
city: Bogotá
country: Colombia
facility: Fundacion Santa Fe de Bogota
state: Cundinamarca
city: Chía
country: Colombia
facility: Clínica Universidad De la Sabana
state: Cundinamarca
city: Monteria
country: Colombia
facility: Fundacion Centro de Excelencia en Enfermedades Cronicas No Transmisibles
state: Córdoba
city: Bogotá
country: Colombia
facility: Clínica de la Mujer S.A.S.
city: Bogotá
country: Colombia
facility: Hospital Universitario Clinica San Rafael
city: Medellín
country: Colombia
facility: Fundacion Hospitalaria San Vicente de Paul
city: Medellín
country: Colombia
facility: Promotora Medica Las Américas S.A- Clínica Las Américas
city: Santiago de Cali
country: Colombia
facility: Fundación Valle Del Lili
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Napoli
country: Italy
facility: Azienda Ospedaliera Cotugno
state: Campania
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
state: Lombardia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
state: Lombardia
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l.
state: Lombardia
city: Monza
country: Italy
facility: ASST di Monza - Azienda Ospedaliera San Gerardo
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
state: Lombardia
city: Busto Arsizio
country: Italy
facility: ASST della Valle Olona - Azienda Ospedaliera Ospedale Di Circolo Di Busto Arsizio
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio González
state: Nuevo Leon
city: Culiacán
country: Mexico
facility: Hospital Civil de Culiacán
state: Sinaloa
city: Culiacán
country: Mexico
facility: Hospital General de Culiacán
state: Sinaloa
city: Comas
country: Peru
facility: Hospital Nacional Sergio E. Bernales
state: Lima
city: Huaral
country: Peru
facility: Hospital Chancay y Servicios Basicos de Salud
state: Lima
city: Miraflores
country: Peru
facility: Hospital Central Fuerza Aérea del Perú
state: Lima
city: San Juan De Miraflores
country: Peru
facility: Hospital María Auxiliadora
state: Lima
city: San Miguel
country: Peru
facility: Clínica Providencia
state: Lima
city: Santiago De Surco
country: Peru
facility: Clínica San Pablo
state: Lima
city: Callao
country: Peru
facility: Hospital Alberto Sabogal Sologuren
city: Cusco
country: Peru
facility: Hospital Nacional Adolfo Guevara Velasco Essalud
city: Lima
country: Peru
facility: Hospital Militar Central
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Guadalajara
country: Spain
facility: Hospital General Universitario de Guadalajara
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca - H. Clinico
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario A Coruña
city: Dnipro
country: Ukraine
facility: Municipal Institution City Clinical Hospital #6 of Dnipropetrovsk Regional Council
state: Dnipropetrovs'ka Oblast
city: Kharkiv
country: Ukraine
facility: Kharkiv Regional Clinical Infectious Diseases Hospital
state: Kharkivs'ka Oblast
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Infectious Hospital
state: Poltavs'ka Oblast
city: Vinnytsya
country: Ukraine
facility: Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
state: Vinnytsia Oblast
city: Lutsk
country: Ukraine
facility: Municipal enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
state: Volyn Oblast
city: Zaporizhzhia
country: Ukraine
facility: MNPE City Hospital No. 6 of Zaporizhzhia City Council
state: Zaporiz'ka Oblast
city: Zhaporizhzhya
country: Ukraine
facility: Municipal Institution City Hospital #7
state: Zaporiz'ka Oblast
city: Chernivtsi
country: Ukraine
facility: CNPE City Clinical Hospital #3 of Chernivtsi City Council
city: Dnipro
country: Ukraine
facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council
Study officials:
affiliation: Corvus Pharmaceuticals
name: S. Mahabhashyam, MD, MPH
role: STUDY_CHAIR
References: