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

ID#: NCT04464395

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: July 01, 2020

End Date: August 31, 2021

Contact Information:
D Strahs
650-900-4518
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.

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