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

Immunotherapy of COVID-19 With B-Cell Activating CPI-006 Monoclonal Antibody

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.

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