Back to resultsA Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lianhua Qingwen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Traditional Chinese Medicine, Randomized Controlled Trial, Lianhua Qingwen
Eligibility Criteria
Inclusion Criteria:
- Age ≥21 years
- Positive laboratory test for COVID-19 by RT-PCR methods
- Presenting with at least one symptom (symptoms include fever, dry cough, sore throat, nasal congestion, malaise, headache, muscle pain, anosmia, and diarrhoea)
- 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
- No clinical or radiographic evidence of pneumonia
- Able to provide informed consent
Exclusion Criteria:
- 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
- Individuals with compromised immune systems such as malignant tumors, organ or bone marrow transplants, HIV, or have taken immunosuppressants in the past three months.
- Women who are pregnant or on lactation.
- Individuals with mental illness.
- History of allergy to any drug or food, or herb ingredient observed in this trial.
- Individuals who are deemed not able to comply with trial procedure or follow-up
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Proportion of participants who test negative for COVID-19
Secondary Outcome Measures
Time taken in days for relief of clinical symptoms
Proportion of participants with mild symptoms of COVID-19 progressing to moderate or severe illness
Proportion of participants who test positive for COVID-19 with Ct value>30
Full Information
NCT ID
NCT04433013
First Posted
June 14, 2020
Last Updated
November 22, 2021
Sponsor
Nanyang Technological University
Collaborators
Ministry of Health, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT04433013
Brief Title
A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19
Official Title
A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to find suitable site Principal Investigator. This study did not start and was withdrawn as of Aug 2020 (have updated as of Sept 2020, please proceed to update the status of study withdrawal accordingly)
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanyang Technological University
Collaborators
Ministry of Health, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Traditional Chinese Medicine, Randomized Controlled Trial, Lianhua Qingwen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lianhua Qingwen
Intervention Description
The LHQW capsules will be administered to trial participants 4 capsules, 3 times a day, after meal
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo capsules will be administered to trial participants 4 capsules, 3 times a day, after meal
Primary Outcome Measure Information:
Title
Proportion of participants who test negative for COVID-19
Time Frame
after 8 days of treatment
Secondary Outcome Measure Information:
Title
Time taken in days for relief of clinical symptoms
Time Frame
during the 8-day course of treatment
Title
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
Title
Proportion of participants who test positive for COVID-19 with Ct value>30
Time Frame
after 8 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥21 years
Positive laboratory test for COVID-19 by RT-PCR methods
Presenting with at least one symptom (symptoms include fever, dry cough, sore throat, nasal congestion, malaise, headache, muscle pain, anosmia, and diarrhoea)
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
No clinical or radiographic evidence of pneumonia
Able to provide informed consent
Exclusion Criteria:
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
Individuals with compromised immune systems such as malignant tumors, organ or bone marrow transplants, HIV, or have taken immunosuppressants in the past three months.
Women who are pregnant or on lactation.
Individuals with mental illness.
History of allergy to any drug or food, or herb ingredient observed in this trial.
Individuals who are deemed not able to comply with trial procedure or follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zhao
Organizational Affiliation
Nanyang Technological University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19
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