Clinical trial NCT04306497: TCM Differentiation and Treatment Protocol of COVID-19
Official title: Clinical Trial of TCM Differentiation and Treatment Protocol of COVID-19 in Jiangsu Province
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Syndrome investigation
differentiation treatment
multicenter cohort study
Lead sponsor: Jiangsu Famous Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-13
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: It conforms to the diagnostic criteria of confirmed cases of COVID-19.

Brief summary: Evaluation of the efficacy and safety of TCM differential treatment of COVID-19 in Jiangsu Province based on the historical prospective multicenter cohort study.

Detailed description: This is a multi-center cross-sectional syndrome investigation study, taking confirmed cases as the main observation object, A prospective multicenter cohort study was designed, focusing on the common type with the largest number of confirmed cases, to evaluate the intervention effect of this project in relieving the disEvaluation of the efficacy and safety of TCM differential treatment of COVID-19 inease and preventing disease progressio.

According to the actual situation of receiving treatment, if the subjects received the combination of western medicine and traditional Chinese medicine, it was the exposure group (integrated traditional Chinese and western medicine cohort), and if the subjects only received western medicine treatment, it was the control group (western medicine cohort). The choice of treatment for patients is entirely determined by clinicians according to the patient's condition, and patients are free to choose after fully understanding different schemes).The choice of control group: COVID-19 (common type) who received routine treatment + antiviral therapy；The choice of exposure group: COVID-19 (common type) who received routine treatment + TCM.The sample size is tentatively set at 340.

Eligibility criteria: Inclusion Criteria:

* It conforms to the diagnostic criteria of confirmed cases of COVID-19 that belongs to the common type;
* The age ranges from 18 to 80 years old, regardless gender；
* In the prospective study, the patient informed consent and sign the informed consent form (if the subject has no capacity, limited capacity and limited expression of personal will, he or she should obtain the consent of his guardian and sign the informed consent at the same time), the retrospective study is visa-free informed consent.

Exclusion Criteria:

* Women during pregnancy or lactation;
* Allergic constitution, such as those who have a history of allergy to two or more drugs or food, or who are known to be allergic to drug ingredients observed in this study.
* Severe complications such as multiple organ failure and shock occurred.
* Complicated with severe primary diseases such as heart, brain, liver, kidney and so on.
* Patients have mental illness.
* Patients who participated in or is currently participating in other clinical trials within the first month of this study.

Primary outcomes:
measure: The relief of main symptoms/ disappearance rate of time
timeFrame: 9day
measure: Chest CT absorption
timeFrame: 9day
Secondary outcomes:
measure: Evaluation standard of comprehensive curative effect
timeFrame: 9day
measure: Virus antigen negative conversion rate
timeFrame: 9day
measure: The number of severe and critical conversion cases
timeFrame: 9day
measure: Incidence of complications
timeFrame: 9day
measure: Traditional Chinese Medicine Syndrome Score
timeFrame: 9day
Other outcomes:
measure: CRP changes
timeFrame: 9day
measure: ESR changes
timeFrame: 9day
measure: PCTchanges
timeFrame: 9day
measure: The index of T cell subsets changed
timeFrame: 9day
Locations:
city: Huaian
country: China
facility: Huai'an fourth people's Hospital
state: Jiangsu
Study officials:
References: