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This study evaluates the effect of Tanshinone capsules in patients with mild or moderate COVID-19 infection. Patients aged 18 to 65 with a confirmed SARS-CoV-2 infection and recently started symptoms could take part. The study was conducted in Phase 2/Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Meet the diagnosis of SARS-CoV-2 infection issued by the National Health Commission of the People's Republic of China (Trial Version 10). Based on the etiology or serological test, within 2 days of diagnosis, and meet the following conditions: 1) The Ct values of N gene and ORF gene of 2019-ncov infection were both less than 30 (fluorescence quantitative PCR method, the cut-off value was 40); 2) Mild and/or moderate clinical classification: subjects had at least one or more of the following clinical symptoms of COVID-19 with a symptom score ≥1 at the time of screening, including but not limited to: fever, cough, sore throat, nasal congestion or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or dyspnea, chills or chills. 2. Age of 18-65 years old, both sexes; 3. Participants were required to meet one or more of the following criteria: 1) ≤3 days from the first administration of the investigational drug to the positive SARS-CoV-2 virus infection test specimen during the screening period, 2) ≤3 days from the first onset of COVID-19 symptoms to the first administration of the investigational drug; 4. Patients voluntarily participated in this study, and they or their legal representatives signed written informed consent and were willing to cooperate with follow-up. Exclusion Criteria: 1. Patients at high risk of severe or critical illness and diagnosed as severe or critical illness before entering the study according to the "Diagnosis and Treatment Protocol for novel coronavirus Infection (Trial version 10)"; 2. Received antiviral treatment before study entry, such as Chinese patent medicine or Chinese medicine formula treatment, Paxlovid, ritonavir tablets, SARS-CoV-2 monoclonal antibody treatment, convalescent plasma of convalescent patients, other clinical trial drugs indicated for COVID-19, etc. (except previous treatment for COVID-19 infection); 3. Subjects with known allergy to therapeutic drug tanshinone capsules or allergic constitution (including susceptible to allergic reactions to other drugs); 4. Suffering from diseases that seriously affect the immune system, such as human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc. 5. Pregnant and lactating women; 6. Suspected bacterial, fungal, viral or other infections other than SARS-CoV-2 during the screening period; 7. Patients with bronchopneumonia, chronic lung abscess, chronic cough for more than 8 weeks, chronic pharyngitis with cough and other diseases before entering the study; 8. One of the following conditions during the screening period: 1) ALT or AST\>1.5 times ULN; 2) eGFR\<60mL/min; 3) hemoglobin \<8.0g/L, platelet \<5000/μL; 9. Patients who participated in other clinical trials within the past 3 months; 10. Persons not eligible for enrollment at the investigator's discretion.