Duvelisib to Combat COVID-19

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.

Timeline

Start

2020-10-12

Primary completion

2022-02-06

Completion

2022-03-02

Outcome

Missed primary endpoint

paper OS at 28 days was 67% (95% confidence interval [CI], 38%-88%) compared to 62% (95% CI, 32%-86%) for placebo (P = .544). PMID 37953814 ↗

paper Duvelisib did not significantly improve 28-day OS compared to placebo for severe COVID-19. PMID 37953814 ↗

Publications

• Goldsmith SR, Covut F, Fiala M, Xiang Z, Iqbal Z, Moore N, Bradtke E, Christen B, Rettig MP, Christ S, Gehrs L, Street E, Wallace N, Ritchey J, Gao F, Pachter J, Parikh B, Dubberke ER, DiPersio JF. Duvelisib for Critically Ill Patients With Coronavirus Disease 2019: An Investigator-Initiated, Randomized, Placebo-Controlled, Double-Blind Pilot Trial. Open Forum Infect Dis. 2023 Oct 27;10(11):ofad518. doi: 10.1093/ofid/ofad518. eCollection 2023 Nov.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duvelisib	Small molecule	25 mg	Oral

Indications