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Randomized Controlled Trial
. 2022 Jul;36(7):2878-2888.
doi: 10.1002/ptr.7455. Epub 2022 Jun 13.

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

Huynh Nguyen Loc  1 , Truong Thi Ngoc Lan  1 , Dinh Thi Lan Huong  2 , Nguyen Thanh Tuyen  1 , Tran Minh Quang  3 , Ly Minh Dao  2 , Pham Hung Van  4 , Nguyen Lam Vuong  5
Affiliations
Randomized Controlled Trial

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

Huynh Nguyen Loc et al. Phytother Res. 2022 Jul.

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.

Keywords: COVID-19; SARS-CoV-2; herbal; traditional medicine.

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Conflict of interest statement

All authors confirm that they have no conflict of interest to declare.

Figures

FIGURE 1
FIGURE 1
Study flow chart
FIGURE 2
FIGURE 2
Daily viral load and time to viral clearance. In (a), the line inside each box is the median, the upper and lower margins of each box represent the interquartile range (25th; 75th percentiles), and the diamond inside each box is the mean of viral load (in log10 transformation). In (b), viral clearance time was censored in 14 patients, including one patient with progression to severe disease at day 3 who was then transferred to another hospital for intensive care, and 13 patients with full recovery whom the viral load was still detectable at discharge. Lines are the Kaplan–Meier estimates and colored regions are 95% confidence intervals
FIGURE 3
FIGURE 3
Daily symptom score and time to resolution of symptoms. In (a), the line inside each box is the median, the upper and lower margins of each box represent the interquartile range (25th; 75th percentiles), and the diamond inside each box is the mean of symptom score. In (b), time to resolution of symptoms was censored in one patient, this patient was with progression to severe disease at day 3 and was then transferred to another hospital for intensive care. Lines are the Kaplan–Meier estimates and colored regions are 95% confidence intervals
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