(17 July 2020) Darunavir- proportion of negative PCR results at day 7 was 46.7% in the DRV/c compared to 60% in control groups

Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19

https://doi.org/10.1093/ofid/ofaa241

In this single-center, randomized, and open-label trial, mild patients with  COVID-19 were enrolled in Shanghai, China. Participants were randomized to receive DRV/c for 5 days on the top of interferon alpha 2b inhaling or interferon alpha 2b inhaling alone. The primary end point was the virological clearance rate of oropharyngeal swabs at day 7 after randomization in the intention-to-treat population (clinicaltrials.gov: NCT04252274). 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. The viral clearance rate at day 3 was 20% (3/15) in both study groups, while the number increased to 26.7% (4/15) in the DRV/c group and remained 20% (3/15) in the control group at day 5. Fourteen days after randomization, 1 participant in the DRV/c group progressed to critical illness and discontinued DRV/c, while all the patients in the control group were stable (P = 1.0). The frequencies of adverse events in the 2 groups were comparable. Five days of DRV/c did not increase the proportion of negative conversion vs standard of care alone, although it was well tolerated.