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

NCT04464395 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CPI-006-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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

Keywords

SARS CoV-2; Coronavirus; Covid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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).

• Duration of symptoms

  Up to 24 weeks after dose of CPI-006.

• Time to discharge

  Up to 24 weeks after dose of CPI-006.

• Rate of medical procedures

  Up to 24 weeks after dose of CPI-006.

• Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels

  Baseline and visits through Day 28.

Study Arms (2)

CPI-006 Dose Escalation

EXPERIMENTAL

CPI-006 + Standard of Care

Drug: CPI-006

Control Arm

OTHER

Standard of Care Only

Other: Standard of Care

Interventions

CPI-006 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.

CPI-006 Dose Escalation

Standard of Care OTHER

Participants will receive standard of care treatment only.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corvus Pharmaceuticals, Inc.: lead

Study Sites (3)

El Centro Regional Medical Center

El Centro, California, 92243, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

CPI-006; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• S. Mahabhashyam, MD. MPH

  Corvus Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 9, 2020
• Study Start: July 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: July 9, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

US (3)