TCM Differentiation and Treatment Protocol of COVID-19 (TDATPOC)

Clinical Trial of TCM Differentiation and Treatment Protocol of COVID-19 in Jiangsu Province

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: TCM prescriptions

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.

• Study Type: Observational
• Enrollment (Actual): 340

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Huaian, Jiangsu, China, 210029
      • Huai'an fourth people's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

It conforms to the diagnostic criteria of confirmed cases of COVID-19.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort of western medicine; Routine treatment：① support treatment:maintain water and electrolyte balance .②oxygen therapy: give nasal catheters to inhale oxygen.③ basic treatment of traditional Chinese and western medicine: antiviral drugs and proprietary Chinese medicines with similar composition or function to the observed scheme of differentiation and treatment of traditional Chinese medicine are not included in the scope of such drugs.; Antiviral drugs ：Clinicians can judge according to the patient's condition according to the latest version of the diagnosis and treatment plan for COvID-19 issued by the General Office of the National Health Commission / the Office of the State Administration of traditional Chinese Medicine (currently the latest version is the sixth trial edition). Select any of the recommended antiviral drugs(for example:IFN-α、lopinavir-ritonavir、Ribavirin、Chloroquine Phosphate、Arbidol)or a combination of two antiviral drugs.	Drug: TCM prescriptions; TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.
Cohort of integrated TCM and western medicine; routine treatment + Antiviral drugs + the following TCM regimens. 1.TCM regimens:① Early stage: Dampness trapped in exterior and interior. Recommended prescription: Huoxiang 15g, Suye15g, Cangzhu15g, Houpo10g, Qianhu15g, Chaihu15g, Huangqin10g, Qinghao20g, Xingren10g, JInyinhua15g, Lianqiao15g. Take decocted or granule, one dose a day. ② Middle stage: Dampness-toxicity blocking lung Recommended prescription: Zhimahuang9g, Xingren10g, Sangbaipi30g, Tinglizi20g, Dongguazi20g, Fabanxia10g, Houpo10g, Suzi15g, Baijiezi10g, Gualoupi15g, Xuanfuhua9g, Xiangfu10g, Yujin10g, Taoren10g, Huangqi20g. Take decocted or granule, one dose a day.	Drug: TCM prescriptions; TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relief of main symptoms/ disappearance rate of time	comparison of the time of relief / disappearance of three main symptoms of fever, cough and shortness of breath	9day
Chest CT absorption	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.	9day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation standard of comprehensive curative effect	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.	9day
Virus antigen negative conversion rate	the detection negative rate of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid.	9day
The number of severe and critical conversion cases	the number of severe and critical cases occurred after the start of intervention.	9day
Incidence of complications	defined as complications during isolation and hospitalization due to pneumonia infected by novel coronavirus, including bacterial infection, aggravation of underlying diseases, etc	9day
Traditional Chinese Medicine Syndrome Score	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.	9day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRP changes	Changes in c-reactive protein.	9day
ESR changes	Changes in erythrocyte sedimentation rate.	9day
PCTchanges	Changes in procalcitonin.	9day
The index of T cell subsets changed	Changes of CD4+ and CD8+	9day

Collaborators and Investigators

• Sponsor: Jiangsu Famous Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2020
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): May 30, 2020

Study Registration Dates

• First Submitted: March 1, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (ACTUAL): March 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Syndrome investigation; differentiation treatment; multicenter cohort study
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: JSZYJ202001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All researchers in this study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No