This study was conducted in a randomized, double-blind, placebo-controlled, multicenter clinical trial design. Two groups were designed, the experimental group and the placebo control group. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.
The purpose of this study was to evaluate the efficacy and safety of Tanreqing capsule in the treatment of mild and common COVID-19. The trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial design. A total of 480 patients were divided into 2 groups: experimental group and control group 3:1. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
480
3 capsules per time, 3 times a day
3 capsules per time, 3 times a day
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
The time from the first dose to sustained clinical recovery
Symptom domains and minors disappear completely within 7 days treatment period after randomization, and maintain it for 2 days without recurrence and the disease don't aggravate
Time frame: 8 days
Novel coronavirus N and ORF gene changes
Nucleic acid detection was performed on the 0, 1, 2, 3, 4, 5, 6 and 7 days respectively. The fluorescent quantitative PCR method was used to determine the Ct value of N gene and ORF gene in novel coronavirus nucleic acid detection. Negative: no Ct value or Ct value\>40. Positive: Ct value\<35. Ct value (cycle threshold) refers to the Ct value of nucleic acid detection, that is, the number of cycles required when the pcr fluorescence signal reaches the threshold.
Time frame: 8 days
The time from the first dose/first testing positive of virus to testing sustained negative of virus within 7 days treatment period after randomization
Testing sustained negative of virus was defined two consecutive (at least 24 hours apart) nasal swabs with new coronavirus nucleic acid detection CT values 35 ,and the negative event date was defined by first negative occurrence.
Time frame: 8 days
Effective rate of wind heat attacking lung syndrome
The time from the first dose to sustained clinical improvement defined total scores for symptom domains and minors was \<3 within 7 days treatment period after randomization.
Time frame: 8 days
Duration of disappearance of main symptoms of wind heat attacking lung syndrome
The time from the first dose to sustained complete disappearance within 7 days treatment period after randomization for every symptom domain, and these two outcomes definition were similar to the primary outcome.
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Time frame: 8 days
Weight conversion rate (ratio of light type to ordinary type and ordinary type to heavy type)
Proportion of patient experiencing progression to severe illness diagnosed by Trial draft version 9 of Diagnosis and Treatment Protocol for novel Coronavirus pneumonia within 7 days treatment period after randomization, during period from the end of 7 days treatment period to discharged from hospital and 3-month follow-up period after discharge.
Time frame: 90 days