Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251871
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaohe Xiao, Beijing 302 Hospital

Tracking Information
First Submitted Date  ICMJE January 28, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date May 5, 2020
Actual Study Start Date  ICMJE January 22, 2020
Estimated Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
The incidents of acute respiratory distress syndrome (ARDS) development [ Time Frame: 14 days ]
The incidence rate of acute respiratory distress syndrome (ARDS) development
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
Time to complete remission of 2019-nCoV infection-associated symptoms [ Time Frame: 28 days ]
Symptoms associated with 2019-nCoV infection involve fever and cough.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • The time to fever resolution rate [ Time Frame: 14 days ]
    Time to complete remission of fever in eligible subjects
  • Time to recovery of lung injury [ Time Frame: 14 days ]
    improvement of chest radiographic evidence indirectly reflects recovery in patients infected with COVID-19.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • The incidence of dyspnea with low oxygen saturation level and high respiratory rate [ Time Frame: 28 days ]
    In eligible subjects, the oxygen saturation level is less than 94%, and the respiratory rate is more than 24 breaths per min.
  • Number of subjects who develop complications of 2019-nCoV infection [ Time Frame: 28 days ]
    Number of subjects who develop complications, including acute respiratory distress syndrome (ARDS), RNAaemia, acute cardiac injury, acute kidney injury (AKI), secondary infection and shock, will be described.
  • Time to virus shedding [ Time Frame: 28 days ]
    Virus shedding was detected twice at least a day apart.
  • Time to improvement of abnormalities in Chest radiology [ Time Frame: 28 days ]
    improvement of chest radiographic evidence indirectly reflects recovery in patients infected with 2019-nCoV.
  • The evaluation of Traditional Chinese Medicine (TCM) symptoms before and after treatment [ Time Frame: 28 days ]
    The changes of TCM symptoms before and after treatment reveal the effect of TCM treatment for 2019-nCoV infection.
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2020)
  • Rate of subjects who die [ Time Frame: 28 days ]
    The rate of subject who die will be described.
  • 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.
  • The length of hospital stays [ Time Frame: 28 days ]
    The length of hospital stays
  • The duration of respiratory support [ Time Frame: 28 days ]
    The duration of respiratory support including invasive and non-invasive mechanical ventilation
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment and Prevention of Traditional Chinese Medicines (TCMs) on COVID-19 Infection
Official Title  ICMJE Effects of Traditional Chinese Medicines (TCMs) on Patients With COVID-19 Infection: A Perspective, Open-labeled, Randomized, Controlled Trial
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia Caused by Human Coronavirus (Disorder)
Intervention  ICMJE
  • 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.

  • 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.
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules
  • 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.
    Intervention: Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 22, 2021
Estimated Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rui-lin Wang, Dr. +86 10 66933436 wrl7905@163.com
Contact: Jia-bo Wang, PD. +86 10 66933323 pharm_sci@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04251871
Other Study ID Numbers  ICMJE 2020001D
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiaohe Xiao, Beijing 302 Hospital
Study Sponsor  ICMJE Beijing 302 Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xiao-he Xiao, PD. 302 Military Hospital
PRS Account Beijing 302 Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP