High-quality trials and pharmacological studies needed as translational evidence for the application of traditional Chinese medicine Lianhua Qingwen against COVID-19.

Traditional Chinese medicine (TCM) has been employed as complementary medication against COVID-19 in China since 2020. Two years since then, TCM, with Lianhua Qingwen (LHQW) as an example, has been included in every version of official clinical protocol guidelines. Recently, LHQW is even distributed to general public at risk but not yet infected. Such common application and widely claimed positive outcome among mild to moderate patients were accompanied by a number of published studies on antiviral, antiinflammatory, and immune modulatory potential using either in vitro or animal models. However, aside from retrospective understanding and open-labeled clinical trials with relatively small subject size, major gap in conclusive proof for efficacy and safety remains due to the lack of double-blind placebo-controlled studies and comprehensive pharmacodynamic and kinetic investigations. This is also supported by a recent WHO expert meeting on this subject, which acknowledged the potential benefits of TCM in mild-moderate cases, while recommended more rigorous studies to further understand effect size, application implications, and outcome determinants. Therefore, there is an urgent need to address the exact role TCM like LHQW could play in COVID-19 management from translational evidence-based perspective. High-quality clinical trials, pharmacological studies, and real-world data from recent outbreak are recommended.