Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Duvelisib · 2 trials · 1 indication
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...
Duvelisib is an investigational small molecule being studied for the treatment of COVID-19. It has been evaluated in two Phase 2 clinical trials in the United States, both of which are completed. The trials enrolled a total of 75 adult patients with COVID-19.
Duvelisib is being developed by Verastem, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VSTM. The company has conducted clinical trials of Duvelisib for COVID-19 in the United States.
Duvelisib is in Phase 2 clinical development for COVID-19. Two Phase 2 trials have been completed, and there are no active trials currently listed. The drug remains investigational and is not approved for this indication.
Duvelisib has been studied in two completed Phase 2 trials for COVID-19: NCT04372602, titled "Duvelisib to Combat COVID-19," with 28 participants, and NCT04487886, titled "Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19)," with 47 participants. Both trials were conducted in the United States.
Yes, the clinical development program for Duvelisib in COVID-19 included randomized, double-blind, sham-controlled trials. The trials enrolled adult patients aged 18 years and older, and both male and female participants were included. The studies were biomarker-selected.