Traditional Vietnamese medicine Kovir capsule for non-severe COVID-19 patients: A phase III double-blind randomized controlled trial.
| Title: | Traditional Vietnamese medicine Kovir capsule for non-severe COVID-19 patients: A phase III double-blind randomized controlled trial. |
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| Authors: | Loc HN; Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Hoan VM; Hanoi General Hospital for Traditional Medicine, Hanoi, Vietnam.; Vuong NL; Department of Medical Statistics and Informatics, Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Lan TTN; Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Huong DTL; Department of Training, Scientific Researching, Health Activities Direction, Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Hung TQ; Hanoi General Hospital for Traditional Medicine, Hanoi, Vietnam.; Tuyen NT; Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Quang TM; General Medicine Department, Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Dao LM; Department of Training, Scientific Researching, Health Activities Direction, Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam. |
| Source: | Phytotherapy research : PTR [Phytother Res] 2023 Jun; Vol. 37 (6), pp. 2395-2404. Date of Electronic Publication: 2023 Feb 07. |
| Publication Type: | Randomized Controlled Trial; Clinical Trial, Phase III; Journal Article |
| Language: | English |
| Journal Info: | Publisher: Wiley Country of Publication: England NLM ID: 8904486 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1099-1573 (Electronic) Linking ISSN: 0951418X NLM ISO Abbreviation: Phytother Res Subsets: MEDLINE |
| Imprint Name(s): | Publication: : Chichester : Wiley; Original Publication: London : Heyden & Son, c1987- |
| MeSH Terms: | COVID-19*/therapy; Adult ; Humans ; Disease Progression ; Double-Blind Method ; Quality of Life ; SARS-CoV-2 ; Southeast Asian People ; Treatment Outcome ; COVID-19 Drug Treatment ; Phytotherapy ; Vietnam ; Medicine, Traditional |
| Abstract: | The number of COVID-19 infections is still increasing with the omicron variant. Although vaccination has shown its effectiveness, efficacious treatments are still required. Kovir, a Vietnamese herbal medicine, has shown potential effects for non-severe COVID-19 patients in terms of symptom resolution and prevention of disease progression in previous studies. This phase-3 trial evaluated the safety and efficacy of Kovir for non-severe COVID-19 adults. Participants were randomized to the Kovir (381 patients) or placebo (192 patients) groups. Outcomes were progression to severe/critical COVID-19, a daily symptom score based on 11 pre-defined symptoms, time to symptom resolution, a negative reverse transcription polymerase chain reaction, an EQ-5D-5L quality of life (QOL) score, and serious adverse events. Only one patient (in the placebo group) progressed to severe COVID-19, thus we could not conclude the effect of Kovir on the prevention of disease progression. Kovir significantly reduced time to symptom resolution (median: 7 vs. 11 days, hazard ratio [95% confidence interval]: 2.03 [1.66-2.48]) compared to placebo. Kovir also increased the QOL score on days 7 and 14. No safety concerns were observed. To conclude, Kovir is safe and facilitates symptom relief for non-severe COVID-19 patients. We advocate using Kovir in the early phase of COVID-19 for non-severe adult patients.; (© 2023 John Wiley & Sons Ltd.) |
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| Grant Information: | Sunstar Joint Stock Company (Sao Thai Duong JSC) |
| Contributed Indexing: | Keywords: COVID-19; Kovir; SARS-CoV-2; herbal; traditional medicine |
| SCR Organism: | SARS-CoV-2 variants |
| Entry Date(s): | Date Created: 20230208 Date Completed: 20230613 Latest Revision: 20230613 |
| Update Code: | 20260130 |
| DOI: | 10.1002/ptr.7761 |
| PMID: | 36751127 |
| Database: | MEDLINE |
Randomized Controlled Trial; Clinical Trial, Phase III; Journal Article