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.
Background: Effective anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) drugs are not only the next defense after vaccines but also the key part of establishing a multi-tiered coronavirus disease 2019 (COVID-19) prevention and control system. Previous studies had indicated that Lianhua Qingwen (LHQW) capsules could be an efficacious Chinese patent drug for treating mild to moderate COVID-19.However, pharmacoeconomic evaluations are lacking, and few trials have been conducted in other countries or regions to evaluate the efficacy and safety of LHQW treatment. So, this study aims to explore the clinical efficacy, safety, and economy of LHQW for treating adult patients with mild to moderate COVID-19.Methods: This is a randomized, double-blind, placebo-controlled, international multicenter clinical trial protocol. A total of 860 eligible subjects are randomized at a 1:1 ratio into the LHQW or placebo group to receive two-week treatment and follow-up visits on days 0, 3, 7, 10, and 14. Clinical symptoms, patient compliance, adverse effects, cost scale, and other indicators are recorded. The primary outcomes will be the measured median time to sustained improvement or resolution of the nine major symptoms during the 14-day observation period. Secondary outcomes regarding clinical efficacy will be evaluated in detail on the basis of clinical symptoms (especially body temperature, gastrointestinal symptoms, smell loss, and taste loss), viral nucleic acid, imaging (CT/chest X-ray), the incidence of severe/critical illness, mortality, and inflammatory factors. Moreover, we will assess health care cost, health utility, and incremental costeffectiveness ratio (ICER) for economic evaluation.Discussion: This is the first international multicenter randomized controlled trial (RCT) of Chinese patent medicine for the treatment of early COVID-19 in accordance with WHO guidelines on COVID-19 management. This study will help clarify the potential efficacy and cost-effectiveness of LHQW in the Registration: This study is registered at the Chinese Clinical Trial Registry, with registration number: ChiCTR2200056727 (date of first registration: 11/02/2022).
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.
Imbalance between exogenous damaging agents and protective factors in the gastro-duodenum tract can lead to peptic ulcer disease. Herbal medicines could be an effective treatment to human gastric ulcers. This study aimed to investigate the protective effect of AGAR-HP hard capsules on cysteamine-induced gastric-duodenal ulcers in experimental rats. The animals were divided into five treatment groups: Group 1 (control) and group 2 (model) were treated with distilled water, group 3 received esomeprazole at 10 mg/kg, group 4 received AGAR-HP at 0.074 g/kg, and group 5 received AGAR-HP at 0.221 g/kg. All the rats were treated for seven consecutive days. On day 7, peptic-duodenal ulcer were induced by oral cysteamine 400 mg/kg. The number of rats with the ulcer, the number of ulcers per rat, and the ulcer index of each group were recorded. Compared to group 2, AGAR-HP at high dose reduced the mean number of ulcers and the ulcer index under macroscopic and microscopic examinations. These parameters also decreased in the group of AGAR-HP low doses compared to the cysteamine control group. AGAR-HP hard capsules showed some protective effect on cysteamine-induced gastric ulcers in experimental rats.
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