Overview
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.
Eligibility
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 at least 92% on 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.
- 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