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

COVID-19 Clinical Trial

Official title:

Immunotherapy of COVID-19 With B-Cell Activating CPI-006 Monoclonal Antibody

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464395
• Other study ID #: CPI-006-002
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2020
• Est. completion date: July 9, 2021

Study information

• Verified date: July 2021
• Source: Corvus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 9, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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 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

Related Conditions & MeSH terms

• COVID-19

Intervention

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:
• Standard of Care
Participants will receive standard of care treatment only.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Corvus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19	Incidence of adverse events (including serious adverse events and dose limiting toxicities).	Up to 30 days after dose of CPI-006.
Primary	Immunoglobulin Anti-SARS CoV-2 Levels	Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.	Baseline and Day 28.
Secondary	Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests	Time to two consecutive negative nasal swab 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).
Secondary	Duration of symptoms	Duration of COVID-19 related symptoms.	Up to 24 weeks after dose of CPI-006.
Secondary	Time to discharge	Time to discharge from hospital.	Up to 24 weeks after dose of CPI-006.
Secondary	Rate of medical procedures	Rate of medical procedures during hospitalization.	Up to 24 weeks after dose of CPI-006.
Secondary	Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels	Difference between Active Arm and Control Arm patients in terms of changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.	Baseline and visits through Day 28.