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Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04464395
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Corvus Pharmaceuticals, Inc.

Brief Summary:
This Phase 1 single-dose, dose-escalation study is an open label trial evaluating the safety of CPI-006, a humanized monoclonal antibody targeting the CD73 cell-surface ectonucleotidase, as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients with a parallel non-randomized Control Arm for treatment with standard of care only.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: CPI-006 Other: Standard of Care Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy of COVID-19 With B-Cell Activating CPI-006 Monoclonal Antibody
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Experimental: CPI-006 Dose Escalation
CPI-006 + Standard of Care
Drug: CPI-006
Participants will receive a single dose of CPI-006 at one of four dose levels (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 5.0 mg/kg) along with standard of care.

Control Arm
Standard of Care Only
Other: Standard of Care
Participants will receive standard of care treatment only.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19 [ Time Frame: Up to 30 days after dose of CPI-006. ]
    Incidence of adverse events (including serious adverse events and dose limiting toxicities).

  2. Immunoglobulin Anti-SARS CoV-2 Levels [ Time Frame: Baseline and Day 28. ]
    Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.


Secondary Outcome Measures :
  1. Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests [ Time Frame: Baseline to two consecutive negative nasal swab PCR SARS CoV-2 viral tests (separated by at least 48 hours). ]
    Time to two consecutive negative nasal swab PCR SARS CoV-2 viral tests.

  2. Duration of symptoms [ Time Frame: Up to 24 weeks after dose of CPI-006. ]
    Duration of COVID-19 related symptoms.

  3. Time to discharge [ Time Frame: Up to 24 weeks after dose of CPI-006. ]
    Time to discharge from hospital.

  4. Rate of medical procedures [ Time Frame: Up to 24 weeks after dose of CPI-006. ]
    Rate of medical procedures during hospitalization.

  5. Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels [ Time Frame: Baseline and visits through Day 28. ]
    Difference between Active Arm and Control Arm patients in terms of changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nasal swab test positive by reverse transcriptase PCR for SARS CoV-2 within past 7 days, and onset of COVID-19 symptoms no more than 10 days prior to the positive test
  • Hospitalized and have stable mild to moderate symptoms of COVID-19
  • Blood oxygen saturation of a minimum of 92% on either no oxygen or up to 5L/min supplemental oxygen
  • Patients with cancer must be in remission or have stable, controlled disease and may be actively receiving drugs or biologics not deemed by the investigator to likely affect immune response.
  • Women must not be of child bearing potential or agree to use contraceptive guidance for 6 weeks

Exclusion Criteria:

  • Patients receiving previous invasive mechanical ventilation or non-invasive ventilation (CPAP, BiPAP) for COVID-19 illness
  • Patients hospitalized >7 days prior to receiving study intervention
  • Other diseases or conditions that are not controlled
  • On drugs or biologics that are immunosuppressive, cytotoxic or immunomodulatory
  • Patients with autoimmune disease must be controlled on non immunosuppressive or immune modifying agents
  • Have received cytotoxic, immunosuppressive or immunomodulatory agents within past 3 months (other than for treatment of COVID-19).
  • Patients receiving experimental therapies that are immunosuppressive
  • Patients receiving non-immuno-suppressive experimental therapies within 7 days prior to receiving CPI-006
  • Patients receiving convalescent plasma within past 30 days
  • Patients receiving experimental anti-SARS CoV-2 monoclonal antibodies within past 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464395


Contacts
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Contact: D Strahs 650-900-4518 DStrahs@corvuspharma.com

Locations
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United States, California
El Centro Regional Medical Center Recruiting
El Centro, California, United States, 92243
Contact: D Strahs    650-900-4518    DStrahs@corvuspharma.com   
Principal Investigator: Christian Tomaszewski, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Dana Ostrowski    212-824-7375    Dana.ostrowski@mssm.edu   
Principal Investigator: Joshua Brody, MD         
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Temple Lung Center    215-707-1359    breathe@tuhs.temple.edu   
Principal Investigator: Gerard J Criner, MD         
Sponsors and Collaborators
Corvus Pharmaceuticals, Inc.
Investigators
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Study Chair: S. Mahabhashyam, MD Corvus Pharmaceuticals
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Responsible Party: Corvus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04464395    
Other Study ID Numbers: CPI-006-002
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corvus Pharmaceuticals, Inc.:
SARS CoV-2
Coronavirus
Covid