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

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CPI-006 Dose Escalation 		CPI-006 + Standard of Care
  • 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
Control Arm 		Standard of Care Only
  • Other: Standard of Care
    Participants will receive standard of care treatment only.

Recruiting Locations

More Details

NCT ID
NCT04464395
Status
Completed
Sponsor
Corvus Pharmaceuticals, Inc.