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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CPI-006
Standard of Care
Sponsored by
Corvus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS CoV-2, Coronavirus, Covid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • El Centro Regional Medical Center
  • Icahn School of Medicine at Mount Sinai
  • Temple University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CPI-006 Dose Escalation

Control Arm

Arm Description

CPI-006 + Standard of Care

Standard of Care Only

Outcomes

Primary Outcome Measures

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).
Immunoglobulin Anti-SARS CoV-2 Levels
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
Time to two consecutive negative nasal swab PCR SARS CoV-2 viral tests.
Duration of symptoms
Duration of COVID-19 related symptoms.
Time to discharge
Time to discharge from hospital.
Rate of medical procedures
Rate of medical procedures during hospitalization.
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.

Full Information

First Posted
July 7, 2020
Last Updated
July 20, 2021
Sponsor
Corvus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04464395
Brief Title
Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients
Official Title
Immunotherapy of COVID-19 With B-Cell Activating CPI-006 Monoclonal Antibody
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
July 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corvus Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS CoV-2, Coronavirus, Covid

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CPI-006 Dose Escalation
Arm Type
Experimental
Arm Description
CPI-006 + Standard of Care
Arm Title
Control Arm
Arm Type
Other
Arm Description
Standard of Care Only
Intervention Type
Drug
Intervention Name(s)
CPI-006
Intervention Description
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
Other
Intervention Name(s)
Standard of Care
Intervention Description
Participants will receive standard of care treatment only.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19
Description
Incidence of adverse events (including serious adverse events and dose limiting toxicities).
Time Frame
Up to 30 days after dose of CPI-006.
Title
Immunoglobulin Anti-SARS CoV-2 Levels
Description
Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
Time Frame
Baseline and Day 28.
Secondary Outcome Measure Information:
Title
Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests
Description
Time to two consecutive negative nasal swab PCR SARS CoV-2 viral tests.
Time Frame
Baseline to two consecutive negative nasal swab PCR SARS CoV-2 viral tests (separated by at least 48 hours).
Title
Duration of symptoms
Description
Duration of COVID-19 related symptoms.
Time Frame
Up to 24 weeks after dose of CPI-006.
Title
Time to discharge
Description
Time to discharge from hospital.
Time Frame
Up to 24 weeks after dose of CPI-006.
Title
Rate of medical procedures
Description
Rate of medical procedures during hospitalization.
Time Frame
Up to 24 weeks after dose of CPI-006.
Title
Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels
Description
Difference between Active Arm and Control Arm patients in terms of changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
Time Frame
Baseline and visits through Day 28.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Mahabhashyam, MD. MPH
Organizational Affiliation
Corvus Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
El Centro Regional Medical Center
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

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

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