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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04487886 | Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19) | PHASE2 | COMPLETED | 47 | — | — | Nov 18, 2020 | Jun 10, 2021 | Apr 7, 2023 | 3 | United States |
| NCT04372602 | Duvelisib to Combat COVID-19 | PHASE2 | COMPLETED | 28 | — | — | Oct 12, 2020 | Mar 2, 2022 | Mar 6, 2023 | 1 | United States |
This is a composite endpoint of the number of participants who require mechanical ventilation or who die within four weeks of randomization.
| Arm | Type | Description |
|---|---|---|
| Duvelisib | EXPERIMENTAL | Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive duvelisib for 14 days. |
| Placebo | PLACEBO_COMPARATOR | Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive a placebo to match duvelisib for 14 days. |
| Name | Type | Description |
|---|---|---|
| Duvelisib | DRUG | Duvelisib will be taken orally at an initial dose of 25 milligrams (mg) twice per day for 14 days. The dose will be de-escalated to 15 mg, twice per day, under certain clinical circumstances. |
| Placebo | DRUG | A placebo to match duvelisib will be taken orally twice per day for 14 days. |
| Peripheral blood draw | PROCEDURE | * First 10 patients enrolled * Screening, Day 2, Day 4, Day 8, Day 10, Day 15, and Day 29 |
Inclusion Criteria: * Hospitalized in participating facility. * Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan). * Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other authorized or approve...