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Completed

NCT Number: NCT05269511

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

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.

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Key information

Conditions

Healthy Participants

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Chinese Medicine, Hong Kong Baptist University

Hong Kong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Chinese herbal medicine

Primary outcomes

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

    Time frame: 3 weeks

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

    Time frame: 3 weeks

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

    Time frame: 3 weeks

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

    Time frame: 3 weeks

Secondary outcomes

  1. Number of days of symptomatic PCR confirmed SARS-CoV-2 infection

    Time frame: 3 weeks

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

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Registry information

Official study title

Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts: A Randomized Controlled Trial

Acronym: CHM COVID-19

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2022
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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