Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04464395 | Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients | PHASE1 | COMPLETED | 30 | — | — | Jul 1, 2020 | Jul 9, 2021 | Jul 21, 2021 | 3 | United States |
Incidence of adverse events (including serious adverse events and dose limiting toxicities).
Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
| Arm | Type | Description |
|---|---|---|
| CPI-006 Dose Escalation | EXPERIMENTAL | CPI-006 + Standard of Care |
| Control Arm | OTHER | Standard of Care Only |
| Name | Type | Description |
|---|---|---|
| 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. |
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 o...