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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Lianhua Qingwen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br> | Drug: Lianhua Qingwen<br>* The LHQW capsules will be administered to trial participants 4 capsules, 3 times a day, after meal<br>|
| Placebo Comparator: Control group<br> | Drug: Placebo<br>* The placebo capsules will be administered to trial participants 4 capsules, 3 times a day, after meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who test negative for COVID-19 |  | after 8 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken in days for relief of clinical symptoms |  | during the 8-day course of treatment | 
| Proportion of participants with mild symptoms of COVID-19 progressing to moderate or severe illness |  | after 8 days of treatment and at the end of the trial | 
| Proportion of participants who test positive for COVID-19 with Ct value>30 |  | after 8 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Traditional Chinese Medicine, Randomized Controlled Trial, Lianhua Qingwen