Treatment and Prevention of Traditional Chinese Medicines (TCMs) on COVID-19 Infection

May 4, 2020 updated by: Xiaohe Xiao, Beijing 302 Hospital

Effects of Traditional Chinese Medicines (TCMs) on Patients With COVID-19 Infection: A Perspective, Open-labeled, Randomized, Controlled Trial

The aim of this study is to test whether Traditional Chinese Medicines (TCMs) are effective and safe for treating COVID-19 infection. After the enrolment of approximately 30 subjects, the recruitment will be paused, and planned interim analysis will be performed to preliminarily investigate the efficacy and safety of TCMs in patients infected with COVID-19.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In December 2019, a cluster of patients with pneumonia in Wuhan, China, was caused by a novel betacoronavirus, which named the 2019 novel coronavirus (COVID-19). It was frequently reported that COVID-19 could be a public health crisis with high infectiousness, and it naturally spread across the country. Most of patients with COVID-19 infection were found to have non-specific symptoms including fever, cough, myalgia and fatigue. In addition, some patients were more likely to develop severe respiratory illness similar to severe acute respiratory syndrome (SARS), or even die. However, there was no timely and effective treatment of patients with COVID-19 infection. Traditional Chinese medicines (TCMs), are derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat the disease. An RCT was performed to investigate TCM was effective and safe for treating COVID-19 infection. Eligible subjects will be randomized in a 1:1 ratio, and 1 subject on conventional medicines and TCMs granules for every 1 subject on conventional medicines. According to recommendations for prevention and control of pneumonia cause by COVID-19 infection from China National Health Commission, conventional medicines involve oxygen therapy and antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, p.o). Additionally, planned interim analysis will be performed, because the prevention and control of COVID-19 infection might affect estimated enrollment.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Recruiting
        • The Fifth Medical Center, General Hospital of PLA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed COVID-19 infection case in term of laboratory evidence;
  • 80 years ≥ age ≥ 14years;
  • Within 72 hours after the onset of abnormalities shown by Chest radiology or several symptoms (fever and cough).

Exclusion Criteria:

  • Age < 14 years or > 80 years;
  • Pregnant or lactating female;
  • One of the following items occurred at the enrollment: (i) respiratory failure necessitating mechanical ventilation; (ii) liver failure: total bilirubin ≥ 10mg/dL and/or severe coagulation disorders; (iii) renal function failure: although adequate circulating blood and cardiac output, urine ≤ 0.5ml/kg·h, Cr or BUN ≥ 1.5 times normal elevation;
  • Intake of Chinese medicinal herbs during the past 2 weeks;
  • Refused to sign an informed consent form prior to study participation;
  • Unwilling and unable to comply with protocol request.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional medicines and TCMs granules

Conventional medicines: oxygen therapy, antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, 400mg/100mg, p.o, bid) for 14 days.

Traditional Chinese Medicines (TCMs) granules: one bag, p.o, bid, for 14 days.
Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules

Conventional medicines: oxygen therapy, antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, 400mg/100mg, p.o, bid) for 14 days.

Traditional Chinese Medicines (TCMs) granules: 20g, p.o, bid, for 14 days.
Active Comparator: Conventional medicines
Conventional medicines: oxygen therapy, antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, 400mg/100mg, p.o, bid) for 14 days.
Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir)
Conventional medicines: oxygen therapy, antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, 400mg/100mg, p.o, bid) for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidents of acute respiratory distress syndrome (ARDS) development
Time Frame: 14 days
The incidence rate of acute respiratory distress syndrome (ARDS) development
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time to fever resolution rate
Time Frame: 14 days
Time to complete remission of fever in eligible subjects
14 days
Time to recovery of lung injury
Time Frame: 14 days
improvement of chest radiographic evidence indirectly reflects recovery in patients infected with COVID-19.
14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of subjects who die
Time Frame: 28 days
The rate of subject who die will be described.
28 days
Rate of subjects receiving systematic corticosteroids
Time Frame: 28 days
The rate of subjects with severe 2019-nCoV infection who receive systematic corticosteroids will be described.
28 days
The length of hospital stays
Time Frame: 28 days
The length of hospital stays
28 days
The duration of respiratory support
Time Frame: 28 days
The duration of respiratory support including invasive and non-invasive mechanical ventilation
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing 302 Hospital

Investigators

  • Study Director: Xiao-he Xiao, PD., 302 Military Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2020

Primary Completion (Anticipated)

January 22, 2021

Study Completion (Anticipated)

January 22, 2021

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020001D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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