Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:Symptomatic treatment + Tanshinone capsules (oral, 4 capsules/time, 3 times/day), 5 days of treatment (compliance)
Control group:Symptomatic treatment + Tanshinone capsule placebo (oral, 4 / time, 3 times/day), the course of five days (compliance)
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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. Aged 18 to 65 years old, gender not limited; 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. Voluntary to participate in this study, patients with himself or his legal representative signed written informed consent, is willing to cooperate with follow-up.
Exclusion criteria
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. Subjects had received antiviral treatment before study entry, such as Chinese patent medicine or Chinese medicine prescription treatment, Paxlovid, ritonavir tablets, SARS-CoV-2 monoclonal antibody treatment, convalescent plasma of recovered patients, and other clinical trial drugs indicated for COVID-19 (except previous treatment for COVID-19 infection); 3. Known tanshinone capsule in treating drug allergy and allergic constitution (including to other drugs, easy to produce allergic reaction) subjects; 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. Subjects had 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) Hb < 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of SARS-CoV-2 nucleic acid negative;Incidence of long-COVID; | — |
Secondary
| Measure | Time frame |
|---|---|
| The disappearance rate and median time of key symptoms (fever, cough, expectoration, sore throat, nasal congestion or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, etc.) of COVID-19 infection disappeared after the first medication;negative conversion rate of SARS-CoV-2 nucleic acid;After the change of the incidence of cardiovascular disease than the control group subjects;The key symptom scores of COVID-19 on the 3rd, 5th and 7th day after treatment were compared with baseline;Change from baseline in CT value for SARS-CoV-2; | — |
Countries
China
Contacts
Public ContactGuodong Hu
The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital)
Outcome results
None listed