COVID-19
Conditions
Keywords
COVID-19, Syndrome investigation, differentiation treatment, multicenter cohort study
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.
Interventions
DRUGTCM prescriptions
TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.
Sponsors
Jiangsu Famous Medical Technology Co., Ltd.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The relief of main symptoms/ disappearance rate of time | 9day | comparison of the time of relief / disappearance of three main symptoms of fever, cough and shortness of breath |
| Chest CT absorption | 9day | with reference to the pneumonia chest X-ray absorption Evaluation scale developed by Renyi Yin et al, the final absorption judgment will be used to evaluate the chest CT absorption of patients with pneumonia, which is divided into four levels according to the degree of absorption: complete absorption, majority absorption, partial absorption and no absorption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Virus antigen negative conversion rate | 9day | the detection negative rate of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid. |
| Evaluation standard of comprehensive curative effect | 9day | With reference to the Therapeutic effect Standard for diagnosis and Syndrome of Traditional Chinese Medicine and guiding principles for Clinical Research of New drugs of traditional Chinese Medicine, the final evaluation was based on clinical remission. |
| The number of severe and critical conversion cases | 9day | the number of severe and critical cases occurred after the start of intervention. |
| Incidence of complications | 9day | defined as complications during isolation and hospitalization due to pneumonia infected by novel coronavirus, including bacterial infection, aggravation of underlying diseases, etc |
| Traditional Chinese Medicine Syndrome Score | 9day | According to the Traditional Chinese Medicine symptom score scale, the change of symptom score before and after treatment was observed.The highest score was 92 points, and the lowest was 23 points. The higher the score, the more severe the symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The index of T cell subsets changed | 9day | Changes of CD4+ and CD8+ |
| PCTchanges | 9day | Changes in procalcitonin. |
| CRP changes | 9day | Changes in c-reactive protein. |
| ESR changes | 9day | Changes in erythrocyte sedimentation rate. |
Countries
China
Outcome results
None listed