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

September 7, 2022 updated by: Corvus Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autónoma de Buenos Aires, Argentina
        • Fundacion Sanatorio Güemes
      • Ciudad Autónoma de Buenos Aires, Argentina
        • Sanatorio Finochietto
      • Córdoba, Argentina
        • Hospital Rawson
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
        • Clínica Zabala
      • Estomba, Buenos Aires, Argentina
        • Clinica Adventista Belgrano
      • La Plata, Buenos Aires, Argentina
        • Instituto Medico Platense
      • Munro, Buenos Aires, Argentina
        • Clinica Independencia
    • Córdoba
      • Río Cuarto, Córdoba, Argentina
        • Instituto Médico Río Cuarto
    • Río Negro
      • Viedma, Río Negro, Argentina
        • Centro de Investigación Clínica - Clínica Viedma
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Hospital Provincial del Centenario
      • Rosario, Santa Fe, Argentina
        • Centro Medico IPAM
    • Tucumán
      • San Miguel De Tucumán, Tucumán, Argentina
        • Hospital de Clínicas Presidente Dr. Nicolás Avellaneda
      • San Miguel de Tucumán, Tucumán, Argentina
        • Clinica Mayo de U.M.C.B. S.R.L
  • Brazil
      • Curitiba, Brazil
        • Centro Hospitalar Nossa Saúde
      • São Caetano do Sul, Brazil
        • Universidade Municipal São Caetano do Sul
      • São Paulo, 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
      • Vitória, Brazil
        • Universidade Federal Do Espirito Santo - Hospital Universitário Cassiano Antônio de Moraes - HUCAM
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Hospital Vera Cruz
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Hospital Agamenon Magalhaes
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Santa Casa de Porto Alegre
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil
        • Hospital Dia do Pulmao
      • Chapecó, Santa Catarina, Brazil
        • Clinica Supera
  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Toronto General Hospital
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve-Rosemont
  • Chile
      • Concepción, Chile
        • Hospital Base de Osorno
      • La Florida, Chile
        • Clinica Vespucio
      • Linares, Chile
        • Research Network Consulting
      • Santiago, Chile
        • Clínica Dávila Y Servicios Médicos SA
  • Colombia
      • Bogotá, Colombia
        • Clínica de la Mujer S.A.S.
      • Bogotá, Colombia
        • Hospital Universitario Clínica San Rafael
      • Medellín, Colombia
        • Fundacion Hospitalaria San Vicente de Paul
      • Medellín, Colombia
        • Promotora Medica Las Américas S.A- Clínica Las Américas
      • Santiago de Cali, Colombia
        • Fundacion Valle del Lili
    • Antioquia
      • Medellín, Antioquia, Colombia
        • Rodrigo Botero S.A.S
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia
        • Fundacion Santa Fe De Bogota
      • Chía, Cundinamarca, Colombia
        • Clinica Universidad de La Sabana
    • Córdoba
      • Monteria, Córdoba, Colombia
        • Fundacion Centro de Excelencia en Enfermedades Cronicas No Transmisibles
  • Germany
    • Niedersachsen
      • Hannover, Niedersachsen, Germany
        • Medizinische Hochschule Hannover
  • Italy
      • Busto Arsizio, Italy
        • ASST della Valle Olona - Azienda Ospedaliera Ospedale Di Circolo Di Busto Arsizio
    • Campania
      • Napoli, Campania, Italy
        • Azienda Ospedaliera Cotugno
    • Lombardia
      • Milano, Lombardia, Italy
        • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
      • Milano, Lombardia, Italy
        • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
      • Milano, Lombardia, Italy
        • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
      • Milano, Lombardia, Italy
        • Ospedale San Raffaele s.r.l.
      • Monza, Lombardia, Italy
        • ASST di Monza - Azienda Ospedaliera San Gerardo
      • Pavia, Lombardia, Italy
        • Fondazione IRCCS Policlinico San Matteo di Pavia
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Hospital Civil Fray Antonio Alcalde
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez
    • Sinaloa
      • Culiacán, Sinaloa, Mexico
        • Hospital Civil de Culiacan
      • Culiacán, Sinaloa, Mexico
        • Hospital General de Culiacan
  • Peru
      • Callao, Peru
        • Hospital Alberto Sabogal Sologuren
      • Cusco, Peru
        • Hospital Nacional Adolfo Guevara Velasco Essalud
      • Lima, Peru
        • Hospital Nacional Guillermo Almenara Irigoyen
      • Lima, Peru
        • Hospital Militar Central
    • Lima
      • Comas, Lima, Peru
        • Hospital Nacional Sergio E. Bernales
      • Huaral, Lima, Peru
        • Hospital Chancay y Servicios Basicos de Salud
      • Miraflores, Lima, Peru
        • Hospital Central Fuerza Aerea Del Peru
      • San Juan De Miraflores, Lima, Peru
        • Hospital Maria Auxiliadora
      • San Miguel, Lima, Peru
        • Clinica Providencia
      • Santiago De Surco, Lima, Peru
        • Clinica San Pablo
  • Spain
      • Barcelona, Spain
        • Hospital Del Mar
      • Guadalajara, Spain
        • Hospital General Universitario de Guadalajara
      • Salamanca, Spain
        • Complejo Asistencial Universitario de Salamanca - H. Clinico
      • Santiago de Compostela, Spain
        • Hospital Universitario A Coruña
    • Málaga
      • Marbella, Málaga, Spain
        • Hospital Costa del Sol
    • Navarra
      • Pamplona, Navarra, Spain
        • Complejo Hospitalario de Navarra
  • Ukraine
      • Chernivtsi, Ukraine
        • CNPE City Clinical Hospital #3 of Chernivtsi City Council
      • Dnipro, Ukraine
        • Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council
    • Dnipropetrovs'ka Oblast
      • Dnipro, Dnipropetrovs'ka Oblast, Ukraine
        • Municipal Institution City Clinical Hospital #6 of Dnipropetrovsk Regional Council
    • Kharkivs'ka Oblast
      • Kharkiv, Kharkivs'ka Oblast, Ukraine
        • Kharkiv Regional Clinical Infectious Diseases Hospital
    • Poltavs'ka Oblast
      • Poltava, Poltavs'ka Oblast, Ukraine
        • Poltava Regional Clinical Infectious Hospital
    • Vinnytsia Oblast
      • Vinnytsya, Vinnytsia Oblast, Ukraine
        • Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
    • Volyn Oblast
      • Lutsk, Volyn Oblast, Ukraine
        • Municipal enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
    • Zaporiz'ka Oblast
      • Zaporizhzhia, Zaporiz'ka Oblast, Ukraine
        • MNPE City Hospital No. 6 of Zaporizhzhia City Council
      • Zhaporizhzhya, Zaporiz'ka Oblast, Ukraine
        • Municipal Institution City Hospital #7
  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Sharp Chula Vista Medical Center
      • El Centro, California, United States, 92243
        • El Centro Regional Medical Center
      • La Mesa, California, United States, 91942
        • Sharp Grossmont Hospital
      • Torrance, California, United States, 90505
        • Torrance Memorial Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Cambridge Medical Trials
      • Metairie, Louisiana, United States, 70006
        • MedPharmics
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Holy Cross Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Cape Fear Valley Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CPI-006 (2 mg/kg) Plus Standard of Care
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.
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
EXPERIMENTAL: CPI-006 (1 mg/kg) Plus Standard of Care
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.
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
PLACEBO_COMPARATOR: Placebo Plus Standard of Care
Participants will receive a single dose of placebo intravenously on Day 1 plus standard of care.
Drug: Placebo + SOC
IV placebo plus standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC
Time Frame: 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.
During the 28 days after dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC
Time Frame: 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.
During the 28 days after dosing
Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC
Time Frame: 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.
During the 28 days after dosing
Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC
Time Frame: During the 28 days after dosing
Proportion of participants who died in each active arm compared to placebo arm
During the 28 days after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corvus Pharmaceuticals, Inc.

Investigators

  • Study Chair: S. Mahabhashyam, MD, MPH, Corvus Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 25, 2021

Primary Completion (ACTUAL)

August 18, 2021

Study Completion (ACTUAL)

August 18, 2021

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (ACTUAL)

February 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPI-006-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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