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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: CPI-006; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • El Centro, California, United States, 92243
      • El Centro Regional Medical Center
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Immunoglobulin Anti-SARS CoV-2 Levels	Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.	Baseline and Day 28.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
Duration of symptoms	Duration of COVID-19 related symptoms.	Up to 24 weeks after dose of CPI-006.
Time to discharge	Time to discharge from hospital.	Up to 24 weeks after dose of CPI-006.
Rate of medical procedures	Rate of medical procedures during hospitalization.	Up to 24 weeks after dose of CPI-006.
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.

Collaborators and Investigators

• Sponsor: Corvus Pharmaceuticals, Inc.
• Investigators: Study Chair: S. Mahabhashyam, MD. MPH, Corvus Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): March 1, 2021
• Study Completion (ACTUAL): July 9, 2021

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (ACTUAL): July 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Coronavirus; SARS CoV-2; Covid
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CPI-006-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No