NCT07123701

Clinical Study of Tanshinone Capsules Against COVID-19

A Randomized Placebo-controlled Clinical Trial of Tanshinone Capsules in the Treatment of Patients With COVID-19

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Liu Shuwen · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The variation of SARS-CoV-2 has caused many countries to face the problem of multiple outbreaks. Gene mutations can change the transmicity, pathogenicity, and immunogenicity of the virus. For example, the Omicron variant circulating around the world spreads faster, increases infectivity, and infects a younger population, which in turn affects the efficacy of antiviral drugs or weakens the protective efficiency of vaccines. Therefore, in order to fully respond to the variation of SARS-CoV-2 and possible new coronaviruses in the future, the development of broad-spectrum anti-coronavirus drugs is an urgent clinical need. Tanshinone capsule is a marketed drug, which is made of the lipid-soluble components of the root of Danshen, a traditional Chinese medicine. It is used for anti-bacterial and anti-inflammatory functions, and is used for acne, tonsillitis and furunils. Its clinical use relives the situation of antibiotic resistance and toxicity. Our previous basic research has shown that tanshinone capsules have anti-SARS-CoV-2 activity in vitro and in humanized ACE2 transgenic mice. The use of tanshinone capsules in the treatment of SARS-CoV-2 infection can further broaden the antiviral pharmacological activity of tanshinone capsules and may increase its clinical function as an antiviral drug for the treatment of viral infection. On the one hand, tanshinone capsules are oral traditional Chinese medicine capsules, which have the advantages of low production/transportation cost, high safety and high patient compliance. On the other hand, tanshinone capsules are expected to reduce the level of inflammation in patients and improve the symptoms of COVID-19 while preventing and treating COVID-19 infection. It can meet the major needs of novel coronavirus pneumonia drug research and development to a high degree.

Conditions

• COVID-19 (Coronavirus Disease 2019)

Interventions

Type	Name	Description
DRUG	Tanshinone capsules	Tanshinone capsules were used in this intervention for COVID-19 patients

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: China