Effect of Traditional Chinese Medicine of Severe COVID-19 (COVID-19)

Integrated Traditional Chinese and Conventional Medicine in Treatment for Patients with Severe COVID-19: Study Protocol for a Randomized Controlled Trial

This study evaluated the effect of integrated traditional Chinese and Western medicine in the treatment of Severe COVID-19. The patients were randomly divided into experimental group and control group.

Study Overview

• Status: Completed
• Conditions: Severe COVID-19
• Intervention / Treatment: Drug: TCM plus conventional drug; Drug: TCM placebo plus conventional drug

Detailed Description

In this study, a multi center randomized controlled trial design was adopted, and the subjects were randomly divided into the experimental group and the control group. The control group was treated with western medicine conventional treatment plus traditional Chinese medicine decoction simulant, while the experimental group was treated with traditional Chinese medicine syndrome differentiation treatment decoction. The course of treatment was 14 days and the patients were followed up for 3 months. The clinical effect of integrated traditional Chinese and Western medicine treatment was evaluated from the aspects of 28 day mortality, 28 days without invasive mechanical ventilation, invasive mechanical ventilation rate, 28 days without ICU stay, clinical stability time, length of hospital stay, quality of life, SOFA score, etc., to clarify the clinical efficacy of integrated traditional Chinese and Western medicine treatment for Severe COVID-19 infection.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• accord with the diagnosis of severe/critical novel coronavirus infection;
• Age > 18 years old;
• TCM syndrome differentiation diagnosis by the attending physician or above or two attending physicians for diagnosis and consensus;
• Sign the informed consent form.

Exclusion Criteria:

• Pregnant and lactating women;
• Trauma, hematological malignancies, various solid tumors and obstetric complications;
• Dementia, various mental patients and those who are unwilling to cooperate;
• The patient is expected to die within the next 24 hours;
• Combined with neuromuscular diseases affecting respiratory and motor functions;
• people who have been bedridden for a long time for various reasons;
• Clinical trial participants who are taking part in other intervention measures;
• Those who are known to be allergic to the therapeutic drugs in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TCM plus conventional drug; The experimental group will receive three type of TCM inaddition conventional drug	Drug: TCM plus conventional drug; All patients were treated according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome.
Placebo Comparator: TCM placebo plus conventional drug; The control group will receive three type of placebo TCM inaddition conventional drug	Drug: TCM placebo plus conventional drug; All patients were treated according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	Proportion of patients who died of disease on day 28	Mortality on the 28th day of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to clinical stability	temperature of 37.2°C orlower, heart rate of 100 beats/min or lower, systolic blood pressure of 90 mm Hg or higher, and arterial oxygen tension of 60 mm Hg or higher when the patient was not receiving supplemental oxygen.	every day in the treatment.
hospitalization time	length of hospital stays will be recorded.	the 28 days of the treatment phase
Days without invasive mechanical ventilation	Days without invasive mechanical ventilation in 28 days	the 28 days of the treatment phase
invasive mechanical ventilation rate	Rate of patients receiving invasive mechanical ventilation	28 days in the treatment phase
days of non-ICU	Calculate the number of days of patients not staying in ICU within 28 days	28 days in the treatment phase
Clinical status of patients 15 days after randomization	According to the 6-point clinical improvement scale of the World Health Organization, the lowest score was 1 and the highest was 6. The higher the score, the worse the result.	The clinical status of patients was observed 15 days after randomization.
Quality of life	Score according to the quality of life table,the minimum score is 12 points, and the maximum score is 60 points. The higher the score, the worse the result.	The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.
TCM syndrome score	Traditional Chinese Medicine Syndrome Points.Including cough, expectoration, dyspnea, chest pain, anorexia and fatigue, each item is rated as 1-5 points from mild to severe.The minimum score is 6 points and the maximum score is 30 points. The higher the score, the worse the result.	The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.
SOFA score	Sequential Organ Failure Assessment.It is a scoring system for evaluating and monitoring the organ function of critically ill patients.The minimum score is 0 and the maximum is 24. The higher the score, the worse the result.	The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2023
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: October 26, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Severe COVID-19
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: TCM for Severe COVID-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No