Clinical trial NCT04433013: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: COVID-19
Keywords: COVID-19
Traditional Chinese Medicine
Randomized Controlled Trial
Lianhua Qingwen
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
First posted: 2020-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of participants who test negative for COVID-19
timeFrame: after 8 days of treatment
Secondary outcomes:
measure: Time taken in days for relief of clinical symptoms
timeFrame: during the 8-day course of treatment
measure: Proportion of participants with mild symptoms of COVID-19 progressing to moderate or severe illness
timeFrame: after 8 days of treatment and at the end of the trial
measure: Proportion of participants who test positive for COVID-19 with Ct value>30
timeFrame: after 8 days of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Nanyang Technological University
name: Yan Zhao
role: PRINCIPAL_INVESTIGATOR
References: