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

• CPI-006 (Drug): 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.
• Standard of Care (Other): Participants will receive standard of care treatment only.

Primary outcomes

• 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 outcomes

• 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.
• Rate of medical procedures [Up to 24 weeks after dose of CPI-006.]: Rate of medical procedures during hospitalization.
• 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.

Sex: All, ages: 18 Years to any

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

• S. Mahabhashyam, MD. MPH, Study chair, Corvus Pharmaceuticals