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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.