COVID-19
Conditions
Keywords
SARS CoV-2, Coronavirus, Covid
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.
Interventions
DRUGCPI-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.
OTHERStandard of Care
Participants will receive standard of care treatment only.
Sponsors
Corvus Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19 | Up to 30 days after dose of CPI-006. | Incidence of adverse events (including serious adverse events and dose limiting toxicities). |
| Immunoglobulin Anti-SARS CoV-2 Levels | Baseline and Day 28. | Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge | Up to 24 weeks after dose of CPI-006. | Time to discharge from hospital. |
| 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). | Time to two consecutive negative nasal swab PCR SARS CoV-2 viral tests. |
| Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels | 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. |
| Rate of medical procedures | Up to 24 weeks after dose of CPI-006. | Rate of medical procedures during hospitalization. |
| Duration of symptoms | Up to 24 weeks after dose of CPI-006. | Duration of COVID-19 related symptoms. |
Countries
United States
Outcome results
None listed