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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Participants will receive standard of care treatment only.
El Centro Regional Medical Center
El Centro, California, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
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).
Time frame: 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.
Time frame: Baseline and Day 28.
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.
Time frame: 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.
Time frame: Up to 24 weeks after dose of CPI-006.
Time to discharge
Time to discharge from hospital.
Time frame: Up to 24 weeks after dose of CPI-006.
Rate of medical procedures
Rate of medical procedures during hospitalization.
Time frame: 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.
Time frame: Baseline and visits through Day 28.
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