COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Experimental group: Shufeng Jiedu Capsule, taken orally for 5 days.
Control group: Shufeng Jiedu placebo, taken orally for 5 days.
After 5 days of treatment, all participants are no longer taking any
Sponsors
Department of Science and Technology of Anhui Province
Anhui Jiren Pharmaceutical Co. LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meet the mild and common diagnostic criteria for COVID-19; 2. The time interval between symptom onset and random enrollment was less than 3 days; 3. Adults (=18 and =75 years); 4. Agree to participate in this study and accept random grouping; 5. Those who have signed informed consent and are not currently participating in other clinical trials of traditional Chinese medicine for COVID-19
Exclusion criteria
Exclusion criteria: 1 Female patients in pregnancy and lactation; 2 Patients with a history of allergy to the test drug ingredients; 3. As judged by the investigator, or patients with acute episodes, cognitive insufficiency, or severe diarrhea (resulting in electrolyte disturbances and dehydration); 4. Continuous use of traditional Chinese medicine (tripartite and three-drug treatment) for COVID-19 within 3 days before enrollment; 5. Patients who are also participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to alleviation of symptoms (TTAS). Clinical symptoms are based on flu-like associated symptoms, including cough, stuffy nose, sore throat, fever or chills, muscle/joint pain, headache, and fatigue measured using self-report on a 0-3 scale (0 as no symptoms, 1 as mild symptoms, 2 as moderate symptoms and 3 as severe symptoms) at baseline, every day during the intervention (from 1st-6th day), and every day during follow-up (since discharged from hospital until 14th day). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Relief time and relief rate of other symptoms (other symptoms are determined according to the epidemic symptoms of COVID-19, including fever, respiratory symptoms (shortness of breath, dry throat, runny nose, etc.), and systemic symptoms (diarrhea, loss of appetite, body pain, smell, taste, nausea) measured scores from 0-3 (0 as no symptoms, 1 as mild symptoms, 2 as moderate symptoms and 3 as severe symptoms) at baseline, every day during the intervention (from 1st-6th day), and every day during follow-up (since discharged from hospital until 14th day). 2. The relief time of a single symptom contained in TTAS and the number of patients with symptom relief at each measurement point measured using patients' self-reported score at baseline, 6th day, the discharged day, 7th day and 14th day after discharge. 3. The number of negative nucleic acid transfers by RT-PCR (Ct values of N gene and ORF gene in two consecutive Novel Coronavirus nucleic acid tests =35), and the samples were nasal swabs at baseline, 3rd day, 6th day, the discharged day, 7th day and 14th day after discharge. 4. Laboratory tests required for leukocyte, lymphocyte, CRP, serum procalcitonin (PCT), inflammatory factor detection (interleukin-6), CD4/CD8, blood oxygen saturation and other signs monitoring at baseline, 3rd day, and 6th day. 5. Chest CT used to observe the changes in lung inflammation at baseline and on the discharge day. 6. Turn heavy rate measured using the number of patients at the 6th day. 7. Safety index (blood routine, coagulation function, electrolytes, urine routine, biochemical indicators) measured using laboratory tests at baseline, and 6th day. Adverse events were measured using patients' self-report during the intervention (from 1st-6th day), and every day during follow-up (since discharged from hospital until the 14th day). | — |
Countries
China
Outcome results
None listed