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

NCT ID: NCT04464395

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-07-09

Brief 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 with a parallel non-randomized Control Arm for treatment with standard of care only.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPI-006 Dose Escalation

CPI-006 + Standard of Care

Group Type: EXPERIMENTAL

CPI-006

Intervention Type: 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.

Control Arm

Standard of Care Only

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

Participants will receive standard of care treatment only.

Interventions

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.

Intervention Type: DRUG

Standard of Care

Participants will receive standard of care treatment only.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corvus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

S. Mahabhashyam, MD. MPH

Role: STUDY_CHAIR

Corvus Pharmaceuticals

Locations

El Centro Regional Medical Center

El Centro, California, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CPI-006-002

Identifier Type: -

Identifier Source: org_study_id