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

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.