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OpenTrials
Completed

NCT Number: NCT04464395

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

El Centro Regional Medical Center, El Centro, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard of care

Other

Participants will receive standard of care treatment only.

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19

    Time frame: Up to 30 days after dose of CPI-006.

    Incidence of adverse events (including serious adverse events and dose limiting toxicities).

  2. Immunoglobulin Anti-SARS CoV-2 Levels

    Time frame: Baseline and Day 28.

    Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.

Secondary outcomes

  1. Negative Nasal Swab Polymerase Chain Reaction (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).

    Time to two consecutive negative nasal swab PCR SARS CoV-2 viral tests.

  2. Duration of symptoms

    Time frame: Up to 24 weeks after dose of CPI-006.

    Duration of COVID-19 related symptoms.

  3. Time to discharge

    Time frame: Up to 24 weeks after dose of CPI-006.

    Time to discharge from hospital.

  4. Rate of medical procedures

    Time frame: Up to 24 weeks after dose of CPI-006.

    Rate of medical procedures during hospitalization.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Corvus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2020
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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