CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Duvelisib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04372602
NCT04372602Phase 2Completed
CompareCT.gov

A Pilot Study of Duvelisib to Combat COVID-19

Washington University School of Medicine·interventional·Posted May 4, 2020·Updated Mar 6, 2023

In Brief

A Phase 2 clinical trial evaluating Duvelisib, Peripheral blood draw, and 1 other intervention for COVID-19. Completed, enrolled 28 participants across 1 site.

Detailed Summary

The exceedingly high mortality rates of severe and critical COVID-19 warrant the identification and evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. Based on preclinical data from this institution and others, the investigators hypothesize that PI3K inhibition with duvelisib could potentially quell aberrant hyperactivtation of the innate immune system, preferentially polarize macrophages, reduce pulmonary inflammation, and limit viral persistence, thereby improving patient outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States
CollaboratorsVerastem, Inc.

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 4, 2020
Enrollment StartOct 12, 2020
Primary CompletionFeb 6, 2022
Study CompletionMar 2, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.2 years ago

Interventions

Duvelisibdrug

-For patients unable to administer orally, a duvelisib suspension will be administered through a nasogastric/orogastric tube.

Peripheral blood drawprocedure

* First 10 patients enrolled * Screening, Day 2, Day 4, Day 8, Day 10, Day 15, and Day 29

Placebodrug

-Provided by Verastem