Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19.
Open Forum Infect Dis
; 7(7): ofaa241, 2020 Jul.
Article
em En
| MEDLINE
| ID: mdl-32671131
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 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 47.2â ±â 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 (Pâ =â .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 (Pâ =â 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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
Idioma:
En
Revista:
Open Forum Infect Dis
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
China