Clinical trial NCT04464395: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: SARS CoV-2
Coronavirus
Covid
Lead sponsor: Corvus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19
timeFrame: Up to 30 days after dose of CPI-006.
measure: Immunoglobulin Anti-SARS CoV-2 Levels
timeFrame: Baseline and Day 28.
Secondary outcomes:
measure: Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests
timeFrame: Baseline to two consecutive negative nasal swab PCR SARS CoV-2 viral tests (separated by at least 48 hours).
measure: Duration of symptoms
timeFrame: Up to 24 weeks after dose of CPI-006.
measure: Time to discharge
timeFrame: Up to 24 weeks after dose of CPI-006.
measure: Rate of medical procedures
timeFrame: Up to 24 weeks after dose of CPI-006.
measure: Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels
timeFrame: Baseline and visits through Day 28.
Other outcomes:
Locations:
city: El Centro
country: United States
facility: El Centro Regional Medical Center
state: California
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Corvus Pharmaceuticals
name: S. Mahabhashyam, MD. MPH
role: STUDY_CHAIR
References: