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.
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.
Other: Standard of Care
Participants will receive standard of care treatment only.
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 24 hours prior to receiving CPI-006
- Patients receiving experimental anti-SARS CoV-2 monoclonal antibodies within past 30
days
El Centro Regional Medical Center
El Centro, California, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
S. Mahabhashyam, MD. MPH, Study Chair
Corvus Pharmaceuticals