Healthy ParticipantsCHM COVID-19NCT05269511
Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts
A study testing Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs. in people with Healthy Participants, run by Hong Kong Baptist University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,163 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2022to 22 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
School of Chinese Medicine, Hong Kong Baptist University
Hong Kong, Hong Kong
About this study
Official title: Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts: A Randomized Controlled Trial
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
- Being tested
- Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.Drug
Also called Chinese herbal medicine
Oral administration, twice per day.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Chinese Herbal Medicine Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who have PCR confirmed SARS-CoV-2 infection
Measured: 3 weeks
Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs
Measured: 3 weeks
Proportion of subjects who subsequently develop COVID-19 symptoms or signs
Measured: 3 weeks
Proportion of subjects who subsequently develop moderate to severe COVID-19 infection
Measured: 3 weeks
Secondary outcomes (2)
Number of days of symptomatic PCR confirmed SARS-CoV-2 infection
Measured: 3 weeks
Number of days of PCR confirmed SARS-CoV-2 infection
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start14 Mar 2022
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhaoXiang Bian, Hong Kong Baptist University
- Investigators
- Aiping Lyu, Study director, School of Chinese Medicine, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269511
- Sponsor's protocol ID
- CHM COVID-19
- Acronym
- CHM COVID-19
- Status last verified
- Apr 2023
- First submitted
- 3 Mar 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the individual participant data that underlie the results reported in the published article will be shared after de-identification.
Publications
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.
PubMed 38799438
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05269511
- Acronym / sponsor ID
- CHM COVID-19 / CHM COVID-19
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,163 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.Chinese Herbal Medicine |
| Control group | No intervention | –usual care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.Also: Chinese herbal medicineOral administration, twice per day. | Drug | Treatment group |
Primary outcome
Proportion of subjects who have PCR confirmed SARS-CoV-2 infection
Time frame: 3 weeks
Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs
Time frame: 3 weeks
Proportion of subjects who subsequently develop COVID-19 symptoms or signs
Time frame: 3 weeks
Proportion of subjects who subsequently develop moderate to severe COVID-19 infection
Time frame: 3 weeks
2 secondary outcomes
Number of days of symptomatic PCR confirmed SARS-CoV-2 infection
Time frame: 3 weeks
Number of days of PCR confirmed SARS-CoV-2 infection
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Derived from this study: PubMed 38799438Du 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.
- Individual participant dataSharing planned: Yes. All the individual participant data that underlie the results reported in the published article will be shared after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiping Lyu study director
School of Chinese Medicine, Hong Kong Baptist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs. in people with Healthy Participants, run by Hong Kong Baptist University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who have PCR confirmed SARS-CoV-2 infection (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05269511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.