Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts

NCT05269511 | Completed

• 1 other identifier: CHM COVID-19
• Study Type: interventional
• Target: 2,163
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, blank-controlled study in adults with household contact exposure to individuals with SARS-CoV-2 infection. All subjects in the study will be household contacts with close exposure to the first household member known to be newly infected with SARS-CoV-2. Subjects in each cohort will be randomly assigned to the Chinese herbal medicine treatment group or blank control group in a 4:1 ratio, followed by 1 week of the treatment period and 2 weeks of follow-up.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• Proportion of subjects who have PCR confirmed SARS-CoV-2 infection

  3 weeks

• Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs

  3 weeks

• Proportion of subjects who subsequently develop COVID-19 symptoms or signs

  3 weeks

• Proportion of subjects who subsequently develop moderate to severe COVID-19 infection

  3 weeks

Secondary Outcomes (2)

• Number of days of symptomatic PCR confirmed SARS-CoV-2 infection

  3 weeks

• Number of days of PCR confirmed SARS-CoV-2 infection

  3 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Chinese Herbal Medicine

Drug: Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.

Control group

NO INTERVENTION

usual care

Interventions

Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs. DRUG

Oral administration, twice per day.

Also known as: Chinese herbal medicine

Treatment group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Household contact exposure to individuals with SARS-CoV-2 infection
• Aged ≥18
• General healthy or have a chronic, stable medical condition
• Voluntarily signing a written informed consent form
• Able to follow written and oral instructions in Chinese

You may not qualify if:

• Moderate to severe symptomatic SARS-CoV-2 infection
• An allergic history to Chinese herbal drugs or a known allergy to the ingredients of the study drug
• Pregnancy, breastfeeding or plan to become pregnant within the study timeframe
• Vulnerable adults (i.e., mentally or physically disabled to take care of himself/herself)
• Any physical examination findings, and/or history of any illness, or concomitant medications that, in the opinion of the study investigator, might not be suitable to participate in the study

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

School of Chinese Medicine, Hong Kong Baptist University

Hong Kong, Hong Kong, China

Location

Related Publications (1)

• Du P, Lam WC, Leung C, Li H, Lyu Z, Yuen CS, Cheung CH, Lam TF, Bian Z, Zhong L. Efficacy and safety of Chinese herbal medicine to prevent and treat COVID-19 household close contacts in Hong Kong: an open-label, randomized controlled trial. Front Immunol. 2024 May 10;15:1359331. doi: 10.3389/fimmu.2024.1359331. eCollection 2024.

  PMID: 38799438 DERIVED

Study Officials

• Aiping Lyu

  School of Chinese Medicine, Hong Kong Baptist University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 8, 2022
• Study Start: March 14, 2022
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

CN (1)