Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPI-006 Dose Escalation | Experimental | CPI-006 + Standard of Care |
|
| Control Arm | Other | Standard of Care Only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to two consecutive negative nasal swab PCR SARS CoV-2 viral tests (separated by at least 48 hours). |
| Duration of symptoms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| S. Mahabhashyam, MD. MPH | Corvus Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Centro Regional Medical Center | El Centro | California | 92243 | United States | ||
| Icahn School of Medicine at Mount Sinai |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000714109 | CPI-006 |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of Care | Other | Participants will receive standard of care treatment only. |
|
Duration of COVID-19 related symptoms. |
| Up to 24 weeks after dose of CPI-006. |
| Time to discharge | Time to discharge from hospital. | Up to 24 weeks after dose of CPI-006. |
| Rate of medical procedures | Rate of medical procedures during hospitalization. | 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. | Baseline and visits through Day 28. |
| New York |
| New York |
| 10029 |
| United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |