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NCT Number: NCT04306497

TCM Differentiation and Treatment Protocol of COVID-19

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Huai'an fourth people's Hospital

Huaian, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TCM prescriptions

Drug

TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.

Primary outcomes

  1. The relief of main symptoms/ disappearance rate of time

    Time frame: 9day

    comparison of the time of relief / disappearance of three main symptoms of fever, cough and shortness of breath

  2. Chest CT absorption

    Time frame: 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 outcomes

  1. Evaluation standard of comprehensive curative effect

    Time frame: 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.

  2. Virus antigen negative conversion rate

    Time frame: 9day

    the detection negative rate of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid.

  3. The number of severe and critical conversion cases

    Time frame: 9day

    the number of severe and critical cases occurred after the start of intervention.

  4. Incidence of complications

    Time frame: 9day

    defined as complications during isolation and hospitalization due to pneumonia infected by novel coronavirus, including bacterial infection, aggravation of underlying diseases, etc

  5. Traditional Chinese Medicine Syndrome Score

    Time frame: 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 outcomes

  1. CRP changes

    Time frame: 9day

    Changes in c-reactive protein.

  2. ESR changes

    Time frame: 9day

    Changes in erythrocyte sedimentation rate.

  3. PCTchanges

    Time frame: 9day

    Changes in procalcitonin.

  4. The index of T cell subsets changed

    Time frame: 9day

    Changes of CD4+ and CD8+

Sponsors and collaborators

Lead sponsor

Jiangsu Famous Medical Technology Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: TDATPOC

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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