Traditional Vietnamese medicine Kovir capsule in patients with mild COVID‐19: A double‐blind randomized controlled trial

Abstract

Kovir capsule, a polyherbal medicine developed from Ren Shen Bai Du San formulation, has been used in various diseases including respiratory infections. A randomized, placebo‐controlled, double‐blind study was conducted to evaluate the safety and efficacy of Kovir capsule (TD0069) in the treatment of mild COVID‐19 patients. Patients aged from 18 to 65 years who were PCR‐confirmed with SARS‐CoV‐2 and had the mild disease were recruited and randomized to either Kovir capsule (34 patients) or placebo (32 patients) for up to 14 days or until discharge. Efficacy outcomes were time to viral clearance, daily viral load, time to symptom resolution, daily symptom score based on 16 pre‐defined symptoms, and progression to severe/critical COVID‐19. Safety outcomes were adverse events. Viral load decreased over time similarly in the two groups. Viral clearance time was also similar in both groups (median: 8 days). Kovir group had a more rapid decrease of symptom score and significantly lower time to symptom resolution than placebo (median: 4 vs. 7 days). Two patients in the placebo group developed severe COVID‐19. No patient experienced adverse events. Kovir capsule is safe and can improve symptom resolution in mild COVID‐19 patients. A large‐scale trial is required to confirm these findings.

Effectiveness of traditional Vietnamese medicine Kovir capsule in adults with mild COVID‐19: A propensity score‐matched study

“…Following the phase‐2 trial on Kovir (Loc et al, 2022 ), this study confirms the clinical effectiveness of Kovir for mild COVID‐19 patients. Kovir facilitates relieving symptoms, shortens time to symptom resolution, and prevents disease progression to severe COVID‐19.…”

“…This study was conducted within the same outbreak with the previous phase‐2 trial on Kovir (Loc et al, 2022 ), in which the Delta variant dominated in our country. Currently, the Omicron variant is the most prevalent in the world.…”

“…Based on the formula of Ren Shen Bai Du San , a famous traditional remedy, a hard‐capsule Vietnamese herbal medicine named “Kovir” has been developed to support the treatment for patients with COVID‐19 in Vietnam. Previously, a phase‐2 trial showed that Kovir capsule (TD0069) was safe and had potential effects on symptom resolution and prevention of progression to severe diseases for patients with mild COVID‐19 (Loc et al, 2022 ).…”

“…In the Kovir group, oral Kovir hard capsule (three capsules three times a day [nine capsules daily in total]) was added. As described elsewhere (Loc et al, 2022 ), there are 12 herbal ingredients in a Kovir capsule; all harmonize to facilitate the reconcilement and recovery of the body.…”

Traditional Vietnamese medicine Kovir capsule for non‐severe COVID‐19 patients: A phase III double‐blind randomized controlled trial

“…A hard‐capsule Vietnamese herbal medicine named “Kovir” has been developed based on a famous remedy formula, Ren Shen Bai Du San , to support treating COVID‐19 patients in Vietnam. There are 12 herbal ingredients in this polyherbal medicine, which are grouped into four categories (Loc, Lan, Huong, Tuyen, Quang, Dao, Van, et al, 2022a): (a) Jun (Chief) targeting the major symptom of the disease, (b) Chen (Deputy) supporting Jun therapeutic effects, (c) Zuo (Assistant) reducing or eliminating possible adverse or toxic effects, and (d) Shi (Envoy) facilitating the delivery of the principal components to the target organs; all harmonize to have antipyretic and analgesic effects, and facilitate the body's reconcilement and recovery. The formula of Kovir follows the principles of traditional medicine in developing a multi‐herbal formula (Yi & Chang, 2004).…”