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

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19
• Intervention / Treatment: Drug: Lianhua Qingwen; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nanyang Technological University
• Collaborators: Ministry of Health, Singapore
• Investigators: Principal Investigator: Yan Zhao, Nanyang Technological University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: June 14, 2020
• First Submitted That Met QC Criteria: June 14, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Randomized Controlled Trial; Traditional Chinese Medicine; Lianhua Qingwen
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IRB-2020-05-029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No