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

Chen, Jun; Xia, Lu; Liu, Li; Xu, Qingnian; Ling, Yun; Huang, Dan; Huang, Wei; Song, Shuli; Xu, Shuibao; Shen, Yingzhong; Lu, Hongzhou

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.