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Effectiveness and safety of Sanhan Huashi granules versus nirmatrelvir-ritonavir in adult patients with COVID-19: A randomized, open-label, multicenter trial.
- Source :
-
Science bulletin [Sci Bull (Beijing)] 2024 Jun 30; Vol. 69 (12), pp. 1954-1963. Date of Electronic Publication: 2024 Apr 23. - Publication Year :
- 2024
-
Abstract
- Sanhan Huashi granules (SHG) demonstrated therapeutic effects against coronavirus disease 2019 (COVID-19) in observational studies. In order to compare the effectiveness and safety of SHG and nirmatrelvir-ritonavir in treating adults with mild-to-moderate COVID-19, we conducted a randomized, active-controlled, open-label, multi-center trial conducted between February and July in 2023. The patients were randomized in a 1:1 ratio to the SHG group and the nirmatrelvir-ritonavir group. A total of 400 participants were randomized, among which 200 participants ultimately received SHG and 198 received nirmatrelvir-ritonavir. The primary outcome was time to sustained clinical recovery through day 28. SHG significantly shortened the median time to sustained clinical recovery compared to nirmatrelvir-ritonavir (6.0 (95% CI, 5.0 to 6.0) vs. 8.0 (95% CI, 6.0 to 9.0) d; P = 0.001), particularly for individual symptoms including fever, sore throat, cough and fatigue. No participants in either group died and incidence of severe COVID-19 showed no difference between two groups. Participants who received nirmatrelvir-ritonavir demonstrated a higher rate of virus clearance on day 5 compared to those received SHG (46.4% (95% CI, 39.1 to 53.7) vs. 65.6% (95% CI, 58.3 to 72.4); P < 0.001). Most adverse events were mild in both groups. In summary, SHG was superior to nirmatrelvir-ritonavir in shortening the time to sustained clinical recovery in participants with mild-to-moderate COVID-19, despite a lower virus clearance rate observed after 5 d of treatment (Chinese Clinical Trial Registry Identifier: ChiCTR2300067872).<br /> (Copyright © 2024 Science China Press. Published by Elsevier B.V. All rights reserved.)
- Subjects :
- Humans
Male
Female
Middle Aged
Adult
Treatment Outcome
Antiviral Agents therapeutic use
Antiviral Agents adverse effects
Antiviral Agents administration & dosage
SARS-CoV-2
COVID-19
Drug Therapy, Combination
Aged
Ritonavir therapeutic use
Ritonavir adverse effects
COVID-19 Drug Treatment
Drugs, Chinese Herbal therapeutic use
Drugs, Chinese Herbal adverse effects
Drugs, Chinese Herbal administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 2095-9281
- Volume :
- 69
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Science bulletin
- Publication Type :
- Academic Journal
- Accession number :
- 38749859
- Full Text :
- https://doi.org/10.1016/j.scib.2024.04.040