Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients
- Registration Number
- NCT04464395
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CPI-006 Dose Escalation CPI-006 CPI-006 + Standard of Care Control Arm Standard of Care Standard of Care Only
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19 Up to 30 days after dose of CPI-006. Incidence of adverse events (including serious adverse events and dose limiting toxicities).
Immunoglobulin Anti-SARS CoV-2 Levels Baseline and Day 28. Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
- Secondary Outcome Measures
Name Time Method Rate of medical procedures Up to 24 weeks after dose of CPI-006. Rate of medical procedures during hospitalization.
Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests 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.
Duration of symptoms Up to 24 weeks after dose of CPI-006. Duration of COVID-19 related symptoms.
Time to discharge Up to 24 weeks after dose of CPI-006. Time to discharge from hospital.
Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels 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.
Trial Locations
- Locations (3)
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
El Centro Regional Medical Center
🇺🇸El Centro, California, United States