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Also known as Copiktra
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...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
Duvelisib was studied in Phase 2 clinical trials as a treatment for COVID-19, the disease caused by the novel coronavirus. The trials evaluated whether the drug could ameliorate manifestations of pneumonia in patients with established coronavirus infection. It was investigated in hospitalized adults aged 18 years and older in the United States.
Duvelisib targets PIK3CG and PIK3CD, which are the gamma and delta isoforms of phosphoinositide 3-kinase (PI3K). It acts as an inhibitor of these enzymes. In the COVID-19 setting, this mechanism was explored for its potential to modulate inflammatory signaling associated with coronavirus infection.
Duvelisib is developed by Verastem, Inc., which trades under the ticker symbol VSTM. Verastem sponsored the clinical research evaluating duvelisib in patients with COVID-19.
Duvelisib was evaluated in Phase 2 clinical trials for COVID-19. Both trials have been completed, and there are no active trials ongoing in this indication. Duvelisib is an investigational agent in the COVID-19 setting and is not approved for that use.
Duvelisib was studied in two completed Phase 2 trials: NCT04487886, titled Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19), which enrolled 47 participants, and NCT04372602, titled Duvelisib to Combat COVID-19, which enrolled 28 participants. Both were conducted in the United States.
The two Phase 2 trials of duvelisib in COVID-19 were randomized, double-blind, and sham-controlled, with a combined enrollment of 75 adults aged 18 years and older. Both studies were conducted in the United States and have been completed.