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A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19

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: NCT04433013
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
Ministry of Health, Singapore
Information provided by (Responsible Party):
Zhao Yan, Nanyang Technological University

Brief Summary:
COVID-19 virus remains in infected patients for extended periods of time. A great resource burden is placed on the healthcare system and society at large to isolate COVID-19 patients for prolonged periods. Thus, being able to increase the rate of viral clearance, thus reducing the duration of COVID-19 infection, would allow patients to be discharged earlier to free up resources for those who require it. The investigators designed a randomized controlled trial, investigating the use of Lianhua Qingwen, a TCM treatment, in COVID-19 infected patients with mild symptoms. The investigators hypothesize that the use of Lianhua Qingwen will increase the proportion of patients who test negative for COVID-19 after 8 days of TCM treatment when compared to the group of patients provided with standard care and placebo. Patients will be recruited from community isolation facilities, and have onset of symptoms within 5 days prior to admission to the isolation facility. The trial also evaluates the time taken for relief of clinical symptoms associated with COVID-19 and assesses the safety of the TCM treatment given to patients.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Lianhua Qingwen Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Experimental: Treatment group Drug: Lianhua Qingwen
The LHQW capsules will be administered to trial participants 4 capsules, 3 times a day, after meal

Placebo Comparator: Control group Drug: Placebo
The placebo capsules will be administered to trial participants 4 capsules, 3 times a day, after meal




Primary Outcome Measures :
  1. Proportion of participants who test negative for COVID-19 [ Time Frame: after 8 days of treatment ]

Secondary Outcome Measures :
  1. Time taken in days for relief of clinical symptoms [ Time Frame: during the 8-day course of treatment ]
  2. Proportion of participants with mild symptoms of COVID-19 progressing to moderate or severe illness [ Time Frame: after 8 days of treatment and at the end of the trial ]
  3. Proportion of participants who test positive for COVID-19 with Ct value>30 [ Time Frame: after 8 days of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥21 years
  2. Positive laboratory test for COVID-19 by RT-PCR methods
  3. Presenting with at least one symptom (symptoms include fever, dry cough, sore throat, nasal congestion, malaise, headache, muscle pain, anosmia, and diarrhoea)
  4. Length of time between date of onset of symptoms and the date of recruitment should not exceed 5 days to ensure that trial participants are in the early stages of infection
  5. No clinical or radiographic evidence of pneumonia
  6. Able to provide informed consent

Exclusion Criteria:

  1. Individuals with underlying primary diseases such as cardiovascular, respiratory, liver, renal, diabetes, hepatitis A/B/C, gout or endocrinological diseases and neurological disorders which put them at a higher risk of developing severe disease
  2. Individuals with compromised immune systems such as malignant tumors, organ or bone marrow transplants, HIV, or have taken immunosuppressants in the past three months.
  3. Women who are pregnant or on lactation.
  4. Individuals with mental illness.
  5. History of allergy to any drug or food, or herb ingredient observed in this trial.
  6. Individuals who are deemed not able to comply with trial procedure or follow-up

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): NCT04433013


Contacts
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Contact: Hui Zi Chua +65 92295363 hzchua_tcm@hotmail.com

Sponsors and Collaborators
Nanyang Technological University
Ministry of Health, Singapore
Investigators
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Principal Investigator: Yan Zhao Nanyang Technological University
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Responsible Party: Zhao Yan, Principal Investigator, Nanyang Technological University
ClinicalTrials.gov Identifier: NCT04433013    
Other Study ID Numbers: IRB-2020-05-029
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 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
Keywords provided by Zhao Yan, Nanyang Technological University:
COVID-19
Traditional Chinese Medicine
Randomized Controlled Trial
Lianhua Qingwen