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

DOI record: { "DOI": "10.1093/ofid/ofaa241", "ISSN": [ "2328-8957" ], "URL": "http://dx.doi.org/10.1093/ofid/ofaa241", "abstract": "<jats:title>Abstract</jats:title>\n <jats:sec>\n <jats:title>Background</jats:title>\n <jats:p>We aimed to evaluate the antiviral activity and safety of darunavir/cobicistat (DRV/c) in treating COVID-19 patients.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>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).</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>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.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Conclusions</jats:title>\n <jats:p>Five days of DRV/c did not increase the proportion of negative conversion vs standard of care alone, although it was well tolerated.</jats:p>\n </jats:sec>", "author": [ { "ORCID": "https://orcid.org/0000-0002-3850-4875", "affiliation": [ { "name": "Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China" } ], "authenticated-orcid": false, "family": "Chen", "given": "Jun", "sequence": "first" }, { "affiliation": [ { "name": "Department of Tuberculosis, Shanghai Public Health Clinical Center, Shanghai, China" } ], "family": "Xia", "given": "Lu", "sequence": "first" }, { "affiliation": [ { "name": "Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China" } ], "family": "Liu", "given": "Li", "sequence": "first" }, { "affiliation": [ { "name": "Department of Traditional Chinese Medicine, Shanghai Public Health Clinical Center, Shanghai, China" } ], "family": "Xu", "given": "Qingnian", "sequence": "first" }, { "affiliation": [ { "name": "Department of Infectious Diseases, Shanghai Public Health Clinical Center, Shanghai, China" } ], "family": "Ling", "given": "Yun", "sequence": "first" }, { "affiliation": [ { "name": "Department of Hepatology, Shanghai Public Health Clinical Center, Shanghai, China" } ], "family": "Huang", "given": "Dan", "sequence": "first" }, { "affiliation": [ { "name": "Department of Tuberculosis, Shanghai Public Health Clinical Center, Shanghai, China" } ], "family": "Huang", "given": "Wei", "sequence": "first" }, { "affiliation": [ { "name": "Department of Cardiovascular Diseases, Shanghai Public Health Clinical Center, Shanghai, China" } ], "family": "Song", "given": "Shuli", "sequence": "first" }, { "affiliation": [ { "name": "Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China" } ], "family": "Xu", "given": "Shuibao", "sequence": "first" }, { "affiliation": [ { "name": "Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China" } ], "family": "Shen", "given": "Yingzhong", "sequence": "first" }, { "affiliation": [ { "name": "Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China" } ], "family": "Lu", "given": "Hongzhou", "sequence": "first" } ], "container-title": "Open Forum Infectious Diseases", "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2020, 6, 21 ] ], "date-time": "2020-06-21T01:23:35Z", "timestamp": 1592702615000 }, "deposited": { "date-parts": [ [ 2020, 7, 10 ] ], "date-time": "2020-07-10T18:14:33Z", "timestamp": 1594404873000 }, "funder": [ { "award": [ "2017ZX09304027" ], "name": "Ministry of Science and Technology of China" }, { "DOI": "10.13039/501100003399", "award": [ "20411950200" ], "doi-asserted-by": "publisher", "id": [ { "asserted-by": "publisher", "id": "10.13039/501100003399", "id-type": "DOI" } ], "name": "Science and Technology Commission of Shanghai Municipality" }, { "award": [ "shslczdzk01102" ], "name": "Shanghai Major Projects on Infectious Diseases" }, { "award": [ "2019–72" ], "name": "Shanghai “Rising Stars of Medical Talent” Youth Development Program" } ], "indexed": { "date-parts": [ [ 2025, 4, 8 ] ], "date-time": "2025-04-08T05:03:47Z", "timestamp": 1744088627896, "version": "3.37.3" }, "is-referenced-by-count": 91, "issue": "7", "issued": { "date-parts": [ [ 2020, 6, 21 ] ] }, "journal-issue": { "issue": "7", "published-print": { "date-parts": [ [ 2020, 7, 1 ] ] } }, "language": "en", "license": [ { "URL": "http://creativecommons.org/licenses/by-nc-nd/4.0/", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2020, 6, 21 ] ], "date-time": "2020-06-21T00:00:00Z", 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the Treatment of COVID-19", "type": "journal-article", "volume": "7" }