The variation of SARS-CoV-2 has caused many countries to face the problem of multipleoutbreaks. Gene mutations can change the transmicity, pathogenicity, and immunogenicityof the virus. For example, the Omicron variant circulating around the world spreadsfaster, increases infectivity, and infects a younger population, which in turn affectsthe 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 newcoronaviruses in the future, the development of broad-spectrum anti-coronavirus drugs isan urgent clinical need. Tanshinone capsule is a marketed drug, which is made of thelipid-soluble components of the root of Danshen, a traditional Chinese medicine. It isused for anti-bacterial and anti-inflammatory functions, and is used for acne,tonsillitis and furunils. Its clinical use relives the situation of antibiotic resistanceand toxicity. Our previous basic research has shown that tanshinone capsules haveanti-SARS-CoV-2 activity in vitro and in humanized ACE2 transgenic mice. The use oftanshinone capsules in the treatment of SARS-CoV-2 infection can further broaden theantiviral pharmacological activity of tanshinone capsules and may increase its clinicalfunction as an antiviral drug for the treatment of viral infection. On the one hand,tanshinone capsules are oral traditional Chinese medicine capsules, which have theadvantages of low production/transportation cost, high safety and high patientcompliance. On the other hand, tanshinone capsules are expected to reduce the level ofinflammation in patients and improve the symptoms of COVID-19 while preventing andtreating COVID-19 infection. It can meet the major needs of novel coronavirus pneumoniadrug research and development to a high degree.
Not Provided
Drug: Tanshinone capsules
Tanshinone capsules were used in this intervention for COVID-19 patients
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.
Dongguan People's Hospital
Dongguan 1812545, Guangdong 1809935, China
guodong G HU, DOCTOR, Principal Investigator
Dongguan People's Hospital