Study Stopped
Sponsor decision. Not related to safety issues.
CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
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
1 other identifier
interventional
46
12 countries
91
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 covid19
Started Feb 2021
Shorter than P25 for phase_3 covid19
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2021
CompletedFirst Posted
Study publicly available on registry
February 2, 2021
CompletedStudy Start
First participant enrolled
February 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2021
CompletedResults Posted
Study results publicly available
August 23, 2022
CompletedSeptember 21, 2022
September 1, 2022
6 months
January 29, 2021
July 29, 2022
September 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC
During the 28 days after dosing
Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC
During the 28 days after dosing
Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC
During the 28 days after dosing
Study Arms (3)
CPI-006 (2 mg/kg) Plus Standard of Care
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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 COMPARATORParticipants will receive a single dose of placebo intravenously on Day 1 plus standard of care.
Interventions
IV CPI-006 2 mg/kg up to a maximum dose of 200 mg plus standard of care
IV CPI-006 1 mg/kg up to a maximum dose of 100 mg plus standard of care
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
Sharp Chula Vista Medical Center
Chula Vista, California, 91911, United States
El Centro Regional Medical Center
El Centro, California, 92243, United States
Sharp Grossmont Hospital
La Mesa, California, 91942, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Cambridge Medical Trials
Alexandria, Louisiana, 71301, United States
MedPharmics
Metairie, Louisiana, 70006, United States
Holy Cross Hospital
Silver Spring, Maryland, 20910, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Cape Fear Valley Medical Center
Fayetteville, North Carolina, 28304, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, 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
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
Montreal, Quebec, H1T 2M4, 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
Montería, Departamento de 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
Hanover, Lower Saxony, Germany
Azienda Ospedaliera Cotugno
Napoli, Campania, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milan, Lombardy, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, Lombardy, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milan, Lombardy, Italy
Ospedale San Raffaele S.r.l.
Milan, Lombardy, Italy
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 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 León, Mexico
Hospital Civil de Culiacán
Culiacán, Sinaloa, Mexico
Hospital General de Culiacán
Culiacán, Sinaloa, Mexico
Hospital Nacional Sergio E. Bernales
Comas, Lima region, Peru
Hospital Chancay y Servicios Basicos de Salud
Huaral, Lima region, Peru
Hospital Central Fuerza Aérea del Perú
Miraflores, Lima region, Peru
Hospital María Auxiliadora
San Juan de Miraflores, Lima region, Peru
Clínica Providencia
San Miguel, Lima region, Peru
Clínica San Pablo
Santiago de Surco, Lima region, 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, Navarre, 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, Dnipropetrovsk Oblast, Ukraine
Kharkiv Regional Clinical Infectious Diseases Hospital
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Poltava Regional Clinical Infectious Hospital
Poltava, Poltava Oblast, Ukraine
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
Vinnytsia, 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, Zaporizhzhia Oblast, Ukraine
Municipal Institution City Hospital #7
Zhaporizhzhya, Zaporizhzhia 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated due to enrollment difficulties and, as a result, some of the originally planned efficacy analyses could not be performed.
Results Point of Contact
- Title
- Study Director
- Organization
- Corvus Pharmaceuticals
Study Officials
- STUDY CHAIR
S. Mahabhashyam, MD, MPH
Corvus Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2021
First Posted
February 2, 2021
Study Start
February 25, 2021
Primary Completion
August 18, 2021
Study Completion
August 18, 2021
Last Updated
September 21, 2022
Results First Posted
August 23, 2022
Record last verified: 2022-09