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Trial record 1 of 1 for:    NCT04251871
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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251871
Recruitment Status : Unknown
Verified May 2020 by Xiaohe Xiao, Beijing 302 Hospital.
Recruitment status was:  Recruiting
First Posted : February 5, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaohe Xiao, Beijing 302 Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pneumonia Caused by Human Coronavirus (Disorder) Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Traditional Chinese Medicines (TCMs) on Patients With COVID-19 Infection: A Perspective, Open-labeled, Randomized, Controlled Trial
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : January 22, 2021
Estimated Study Completion Date : January 22, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The incidents of acute respiratory distress syndrome (ARDS) development [ Time Frame: 14 days ]
    The incidence rate of acute respiratory distress syndrome (ARDS) development


Secondary Outcome Measures :
  1. The time to fever resolution rate [ Time Frame: 14 days ]
    Time to complete remission of fever in eligible subjects

  2. Time to recovery of lung injury [ Time Frame: 14 days ]
    improvement of chest radiographic evidence indirectly reflects recovery in patients infected with COVID-19.


Other Outcome Measures:
  1. Rate of subjects who die [ Time Frame: 28 days ]
    The rate of subject who die will be described.

  2. 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.

  3. The length of hospital stays [ Time Frame: 28 days ]
    The length of hospital stays

  4. The duration of respiratory support [ Time Frame: 28 days ]
    The duration of respiratory support including invasive and non-invasive mechanical ventilation


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251871


Contacts
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Contact: Rui-lin Wang, Dr. +86 10 66933436 wrl7905@163.com
Contact: Jia-bo Wang, PD. +86 10 66933323 pharm_sci@126.com

Locations
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China, Beijing
The Fifth Medical Center, General Hospital of PLA Recruiting
Beijing, Beijing, China, 100039
Contact: Rui-lin Wang, Dr.    +86 66933323    wrl7905@163.com   
Sponsors and Collaborators
Beijing 302 Hospital
Investigators
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Study Director: Xiao-he Xiao, PD. 302 Military Hospital
More Information
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Publications:
World Health Organization. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected: interim guidance. Published January 28, 2020. Accessed January 31, 2020. https://www. who.int/publications-detail/clinical-managementof- severe-acute-respiratory-infection-when-novelcoronavirus-( ncov)-infection-is-suspected

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xiaohe Xiao, Principal Investigator, Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT04251871    
Other Study ID Numbers: 2020001D
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
COVID-19
Infections
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Pneumonia, Viral
Interferons
Ritonavir
Lopinavir
 Interferon-alpha
Interferon-alfa-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Immunologic Factors