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

Sponsor

Corvus Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04464395

Collaborator

(none)

Enrollment

Locations

Arms

12.3

Actual Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: CPI-006 Other: Standard of Care	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Jul 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19 [Up to 30 days after dose of CPI-006.]
Incidence of adverse events (including serious adverse events and dose limiting toxicities).
Immunoglobulin Anti-SARS CoV-2 Levels [Baseline and Day 28.]
Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.

Secondary Outcome Measures

Negative Nasal Swab Polymerase Chain Reaction (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).]
Time to two consecutive negative nasal swab PCR SARS CoV-2 viral tests.
Duration of symptoms [Up to 24 weeks after dose of CPI-006.]
Duration of COVID-19 related symptoms.
Time to discharge [Up to 24 weeks after dose of CPI-006.]
Time to discharge from hospital.
Rate of medical procedures [Up to 24 weeks after dose of CPI-006.]
Rate of medical procedures during hospitalization.
Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels [Baseline and visits through Day 28.]
Difference between Active Arm and Control Arm patients in terms of changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	El Centro Regional Medical Center	El Centro	California	United States	92243
2	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
3	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

Corvus Pharmaceuticals, Inc.

Investigators

Study Chair: S. Mahabhashyam, MD. MPH, Corvus Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Corvus Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT04464395

Other Study ID Numbers:

CPI-006-002

First Posted:

Jul 9, 2020

Last Update Posted:

Jul 21, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Corvus Pharmaceuticals, Inc.

SARS CoV-2

Coronavirus

Covid

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jul 21, 2021