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Treatment and Prevention of Traditional Chinese Medicines (TCMs) on 2019-nCoV 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 : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaohe Xiao, Beijing 302 Hospital

Brief Summary:
The aim of this study is to test whether Traditional Chinese Medicines (TCMs) are effective and safe for treating 2019-nCoV 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 2019-nCoV.

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 (2019-nCoV). It was frequently reported that 2019-nCoV could be a public health crisis with high infectiousness, and it naturally spread across the country. Most of patients with 2019-nCoV 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 2019-nCoV 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 2019-nCoV 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 2019-nCoV 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 2019-nCoV infection might affect estimated enrollment.

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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 2019-nCoV 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


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.




Primary Outcome Measures :
  1. Time to complete remission of 2019-nCoV infection-associated symptoms [ Time Frame: 28 days ]
    Symptoms associated with 2019-nCoV infection involve fever and cough.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Time to virus shedding [ Time Frame: 28 days ]
    Virus shedding was detected twice at least a day apart.

  4. 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.

  5. 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.


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



Information from the National Library of Medicine

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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 2019-nCoV 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.

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

Publications:
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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: February 5, 2020
Last Verified: January 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
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Interferons
Ritonavir
Antiviral Agents
Lopinavir
Interferon-alpha
Antineoplastic Agents
Anti-Infective Agents
HIV 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
Physiological Effects of Drugs