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.
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
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
Sharp Chula Vista Medical Center
Chula Vista, California, United States
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, Argentina
Centro de Investigación Clínica - Clínica Viedma
Viedma, Río Negro, 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
Fundación Sanatorio Güemes
Ciudad Autónoma de Buenos Aires, Argentina
Sanatorio Finochietto
Ciudad Autónoma de Buenos Aires, Argentina
Hospital Rawson
Córdoba, Argentina
Hospital Vera Cruz
Belo Horizonte, Minas Gerais, Brazil
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
Centro Hospitalar Nossa Saúde
Curitiba, 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, Brazil
Toronto General Hospital
Toronto, Ontario, Canada
Hôpital Maisonneuve-Rosemont
Montréal, Quebec, Canada
Hospital Base de Osorno
Concepción, Chile
Clinica Vespucio
La Florida, Chile
Research Network Consulting
Linares, Chile
Clínica Dávila Y Servicios Médicos SA
Santiago, Chile
Rodrigo Botero S.A.S
Medellín, Antioquia, Colombia
Fundacion Santa Fe de Bogota
Bogotá, Cundinamarca, Colombia
Clínica Universidad De la Sabana
Chía, Cundinamarca, Colombia
Fundacion Centro de Excelencia en Enfermedades Cronicas No Transmisibles
Monteria, Córdoba, Colombia
Clínica de la Mujer S.A.S.
Bogotá, Colombia
Hospital Universitario Clinica San Rafael
Bogotá, Colombia
Fundacion Hospitalaria San Vicente de Paul
Medellín, Colombia
Promotora Medica Las Américas S.A- Clínica Las Américas
Medellín, Colombia
Fundación Valle Del Lili
Santiago de Cali, Colombia
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany
Azienda Ospedaliera Cotugno
Napoli, Campania, 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
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardia, Italy
ASST della Valle Olona - Azienda Ospedaliera Ospedale Di Circolo Di Busto Arsizio
Busto Arsizio, Italy
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Hospital Universitario Dr. Jose Eleuterio González
Monterrey, Nuevo Leon, Mexico
Hospital Civil de Culiacán
Culiacán, Sinaloa, Mexico
Hospital General de Culiacán
Culiacán, Sinaloa, Mexico
Hospital Nacional Sergio E. Bernales
Comas, Lima, Peru
Hospital Chancay y Servicios Basicos de Salud
Huaral, 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, Peru
Hospital Alberto Sabogal Sologuren
Callao, Peru
Hospital Nacional Adolfo Guevara Velasco Essalud
Cusco, Peru
Hospital Militar Central
Lima, Peru
Hospital Nacional Guillermo Almenara Irigoyen
Lima, Peru
Hospital Costa del Sol
Marbella, Málaga, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarra, Spain
Hospital del Mar
Barcelona, Spain
Hospital General Universitario de Guadalajara
Guadalajara, Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, Spain
Hospital Universitario A Coruña
Santiago de Compostela, Spain
Municipal Institution City Clinical Hospital #6 of Dnipropetrovsk Regional Council
Dnipro, Dnipropetrovs'ka Oblast, Ukraine
Kharkiv Regional Clinical Infectious Diseases Hospital
Kharkiv, Kharkivs'ka 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
Municipal enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
Lutsk, Volyn 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, Ukraine
CNPE City Clinical Hospital #3 of Chernivtsi City Council
Chernivtsi, Ukraine
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council
Dnipro, Ukraine
S. Mahabhashyam, MD, MPH, Study Chair
Corvus Pharmaceuticals