Preprint / Version 1

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

Authors

  • Huynh Loc Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam
  • Truong Lan Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam
  • Dinh Huong Department of Training, Scientific Researching, Health Activities Direction, Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam
  • Nguyen Tuyen Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam
  • Tran Quang General Medicine Department, Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam
  • Ly Dao Department of Training, Scientific Researching, Health Activities Direction, Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam
  • Pham Van International Institute of Gene and Immunology (IGI), Ho Chi Minh City, Vietnam
  • Nguyen Vuong 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

Keywords:

COVID‐19, herbal, SARS‐CoV‐2, traditional medicine

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, herbal, SARS‐CoV‐2, traditional medicine