Status:
COMPLETED
Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients
Lead Sponsor:
Corvus Pharmaceuticals, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 immunother...
Eligibility Criteria
Inclusion
- 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
- 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 24 hours prior to receiving CPI-006
- Patients receiving experimental anti-SARS CoV-2 monoclonal antibodies within past 30 days
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04464395
Start Date
July 1 2020
End Date
July 9 2021
Last Update
July 21 2021
Active Locations (3)
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1
El Centro Regional Medical Center
El Centro, California, United States, 92243
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
3
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140