Journal
OPEN FORUM INFECTIOUS DISEASES
Volume 7, Issue 7, Pages -Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/ofid/ofaa241
Keywords
antiviral activity; COVID-19; darunavir; protease inhibitors; SARS-CoV-2
Categories
Funding
- Ministry of Science and Technology of China [2017ZX09304027]
- Shanghai Science and Technology Committee [20411950200]
- Shanghai Major Projects on Infectious Diseases [shslczdzk01102]
- Shanghai 'Rising Stars of Medical TalentYouth Development Program, Specialist Program [2019-72]
Ask authors/readers for more resources
Background. We aimed to evaluate the antiviral activity and safety of darunavir/cobicistat (DRV/c) in treating COVID-19 patients. Methods. In this single-center, randomized, and open-label trial, mild patients with polymerase chain reaction (PCR)-confirmed 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). Results. From January 30, 2020, to February 6, 2020, a total of 30 patients were enrolled, of whom 18 (60%) were male, aged 47.2 +/- 2.8 years; 63.3% (19/30) of the participants had fever, and 46.7% (14/30) had cough at enrollment. The participants were randomized (range) at 4 (2-5) days after onset of symptoms. 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. Conclusions. Five days of DRV/c did not increase the proportion of negative conversion vs standard of care alone, although it was well tolerated.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available