[Source: Open Forum Infectious Diseases, full page: (LINK). Abstract, edited.]
Antiviral Activity and Safety of Darunavir/Cobicistat for Treatment of COVID-19
Jun Chen, Lu Xia, Li Liu, Qingnian Xu, Yun Ling, Dan Huang, Wei Huang, Shuli Song, Shuibao Xu, Yingzhong Shen, Hongzhou Lu
Open Forum Infectious Diseases, ofaa241, https://doi.org/10.1093/ofid/ofaa241
Published: 21 June 2020
Abstract
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 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 endpoint was the virological clearance rate of oropharyngeal swabs at day 7 after randomization in the intention-to-treat population. (clinicaltrials.gov: NCT04252274)
Results
From Jan 30, 2020 to Feb 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 at 4(2-5) days after onset of symptoms. The proportions of negative PCR results at day 7 was 46·7%(7/15) and 60·0%(9/15) in the DRV/c and the control group (P=0·72), respectively. The viral clearance rate at day 3 was both 20%(3/15) in the two study groups while the number increased to 26·7%(4/15) in the DRV/c group and maintained 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 frequency of adverse events in the two groups were comparable.
Conclusion
Five days of DRV/c did not increase the proportion of negative conversion than standard of care alone, although it was well tolerated.
COVID-19, SARS-CoV-2, Antiviral Activity, Darunavir, Protease inhibitors
Issue Section: Major Article
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© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
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Keywords: SARS-CoV-2; COVID-19; Antivirals; Darunavir; Cobicistat.
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