Efficacy and safety of Lianhua Qingwen capsule combined with standard care in the treatment of adult patients with mild to moderate COVID-19: randomized, double-blind, international multi-center clinical trial protocol
Effective anti-Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) drugs are not only the next line of defense after vaccines, but also a key part of establishing a multi-tiered coronavirus disease (COVID-19) prevention and control system in 2019. Previous studies have shown that Lianhua Qingwen capsule may be an effective proprietary Chinese medicine for treating mild to moderate COVID-19. However, pharmacoeconomic evaluations are lacking, and few trials have been conducted in other countries to evaluate the efficacy and safety of Lianhua Qingwen jiaonang therapy. Therefore, this study aims to investigate the clinical efficacy, safety and economy of Lianhua Qingwen jiaonang in the treatment of adult patients with mild to moderate COVID-19.
This is a randomized, double-blind, placebo-controlled international multicenter clinical trial protocol. A total of 860 eligible subjects were randomly assigned 1:1 to either Lianhua Qingwen jiaonang or placebo to receive two-week treatment and follow-up on days 0, 3, 7, 10, and 14. Clinical symptoms, patient compliance, adverse reactions, cost scale, and other metrics were recorded. The primary outcome will be the median time for sustained improvement or remission of the nine major symptoms over the 14-day observation period. Secondary outcomes of clinical efficacy will be evaluated in detail based on clinical symptoms (especially temperature, gastrointestinal symptoms, loss of smell and taste), viral nucleic acids, imaging (CT/ chest X-rays), incidence of severe/critical illness, mortality, and inflammatory factors. In addition, we will evaluate healthcare costs, medical utility, and incremental cost-benefit ratio (ICER) for economic assessment.
This is the first international multi-centre randomised controlled trial (RCT) conducted in accordance with the WHO guidelines for the management of COVID-19. This study will help clarify the potential efficacy and cost-effectiveness of Lianhua Qingwen jiaonang in treating mild-to-moderate COVID-19 and facilitate decision making by healthcare professionals.
