Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19

NCT04252274 ↗

Phase 3 Unknown 30 enrolled Shanghai Public Health Clinical Center

RandomizedParallel-groupOpen-labelTreatment

Summary

The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia

Timeline

Start: 2020-01-30
Primary completion: 2020-08-31
Completion: 2020-12-31

Outcome

Missed primary endpoint

paper The proportion of negative PCR results at day 7 was 46.7% (7/15) and 60.0% (9/15) in the DRV/c and control groups (P = .72), respectively. PMID 32671131 ↗

paper Five days of DRV/c did not increase the proportion of negative conversion vs standard of care alone, although it was well tolerated. PMID 32671131 ↗

release “darunavir and cobicistat (DRV/c) in treating laboratory-confirmed 30 COVID-19 patients showed that DRV/c was not effective.” jnj.com ↗

Publications

Chen J, Xia L, Liu L, Xu Q, Ling Y, Huang D, Huang W, Song S, Xu S, Shen Y, Lu H. Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19. Open Forum Infect Dis. 2020 Jun 21;7(7):ofaa241. doi: 10.1093/ofid/ofaa241. eCollection 2020 Jul.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cobicistat	Small molecule	—	—
Subject	Darunavir	Small molecule	—	—