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

NCT04433013 | Withdrawn Phase 3

• 1 other identifier: IRB-2020-05-029
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19

Keywords

COVID-19; Traditional Chinese Medicine; Randomized Controlled Trial; Lianhua Qingwen

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who test negative for COVID-19

  after 8 days of treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

Treatment group

EXPERIMENTAL

Drug: Lianhua Qingwen

Control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lianhua Qingwen DRUG

The LHQW capsules will be administered to trial participants 4 capsules, 3 times a day, after meal

Treatment group

Placebo DRUG

The placebo capsules will be administered to trial participants 4 capsules, 3 times a day, after meal

Control group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanyang Technological University: lead
• Ministry of Health, Singapore: collaborator

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yan Zhao

  Nanyang Technological University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 16, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share