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COVID-19Phase 2/3NCT05275933

Efficacy of TCM Capsules Lian Hua Qing Wen Jiao Nang in Mild COVID-19 Patients

A Phase 2/3 study testing TCM intervention in people with COVID-19, run by Singapore Chung Hwa Medical Institution at 2 sites in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research aims to investigate the adjuvant effect of LH in reducing the symptomatic duration of fully vaccinated, mild COVID-19 patients on home recovery program in Singapore. Read more about this study

Who is it for?
Ages 21 to 79 years
Conditions the study is for
COVID-19
What is being tested?
TCM intervention
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
2 sitesSingapore
Study dates
5 Apr 2022to 22 Nov 2023
Phase
Phase 2/3
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 21 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants of age 21 to 79 years, all gender and races.
  • Participant provides informed consent prior to initiation of any study procedures.
  • Fully vaccinated (according to latest MOH criteria. Refer to Appendix 1) and qualified for Protocol 2 Primary Care (P2PC) (Appendix 2).
  • Documentation of confirmed active SARS-CoV-2 infection, as determined by PHPC and MOH.
  • Mild COVID-19 experiencing at least one SARS-CoV-2 infection symptom within the first two days of COVID-19 diagnosis including symptoms of mild illness with COVID-19 (based on Questionnaire 6.2) that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea, with stable vital signs.
  • Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period up until reaching hospitalization or 28 days, whichever is earliest.
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  • Agrees to not utilize TCM or other alternative medicine and supplements outside of this study during the 7-day period.
  • Willing to be randomized to LH and PC arm for 7 days and followed up to 28 days.
  • Willing to comply with the study related questionnaires, procedures, and measurements.
  • Willing to not become pregnant during the 7 days of LH ingestion using appropriate accepted methods of contraception. Acceptable methods of contraception include: postmenopausal 1 year of amenorrhea and over 50 years of age; prior tubal ligation or hysterectomy; or barrier contraception using condom or diaphragm plus spermicide.
  • Able to provide the identity of their health care provider or health system clinical care entry information (if any).
  • Able to utilize telephone, WhatsApp apps and/or Online platform (Zoom/ VooV) to comply with the study related questionnaires, procedures, and measurements, established during the recruitment process.
  • Able to speak and communicate in basic English.

Who cannot join

  • Not fully vaccinated (according to latest MOH criteria. Refer Appendix 1).
  • Patients classified under Protocol 1 according to latest MOH Criteria (Appendix 2) or required hospitalisation (based on PI/Co-I's diagnosis).
  • TCM syndrome of cold deficiencies in spleen and stomach (for example: long-term loose stool), qi and blood debilitation (for example: long-term dizziness).
  • Positive SARS-CoV-2 molecular test in the absence of COVID-19 symptoms from day 1 (Asymptomatic), PCR/ ART test is negative.
  • Moderate, Severe or Critical COVID-19:
  • Moderate Covid-19: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) ≥94% on room air at sea level.
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  • Severe COVID-19: Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress
  • Clinical signs indicative of severe systemic illness with COVID-19, respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air at sea level or respiratory PaO2/FiO2 < 300.
  • Critical COVID-19; Evidence of critical illness, defined by at least one of the following:
  • Respiratory failure defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5), non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation).
  • Shock (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressors).
  • Multi-organ dysfunction/failure.
  • Use of drugs for anti-SARS-CoV-2 treatment including remdesivir, baricitinib, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, and azithromycin, dexamethasone, bamlanivimab, casirivimab plus imdevimab convalescent plasma, or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis.
  • Participating in a study where co-enrolment is not allowed.
  • Known allergy/sensitivity or any hypersensitivity to components of LH or standard care medication.
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
  • Has known prior kidney disease.
  • Has known cirrhosis, acute liver disease or uncontrolled chronic liver disease.
  • Has known narrow angle glaucoma.
  • Has Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • On psychiatric medication including Monoamine oxidase inhibitors (MAOIs).
  • If has (a) three or more co-morbidities / chronic conditions even if they are under controlled, or (b) one uncontrolled chronic condition. Chronic diseases include cardiovascular disease (coronary artery disease, heart failure, valvular heart disease), hypertension, diabetes, hyperlipidaemia, chronic lung disease, chronic kidney disease, chronic liver disease, chronic thyroid disease, immunocompromised (HIV or daily users of more than 5 mg/day of prednisone), prior organ transplant, epilepsy.
  • Currently undergoing chemotherapy, radiotherapy, targeted therapy, or immuno-therapy treatment.
  • Fulfils the MOH criteria of at high risk for progressing to severe COVID-19.
  • Women who are currently pregnant or breastfeeding.

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites

  • Ubi Family Clinic & Surgery

    Singapore, 400305

  • Banyan clinic @ jw private limited

    Singapore, 640502

Other trials in Singapore

About this study

Official title: Assessing the Efficacy of TCM Capsules Lian Hua Qing Wen Jiao Nang as Adjuvant Treatment in Mild COVID-19 Patients on Home Recovery Program in Singapore: a Randomised, Double-blind, Placebo-controlled Study

This research aims to investigate the adjuvant effect of LH in reducing the symptomatic duration of fully vaccinated, mild COVID-19 patients on home recovery program in Singapore. It is aimed to assist policymakers in incorporating clinically proven TCM treatment for mild COVID-19 patients on home recovery program, and establishing a guideline on TCM pandemic treatment protocol which is suitable to be integrated into the healthcare system.

Read the detailed description

Importance With the emergence of Covid-19 variants and despite having 93% population vaccination rate, the daily number of community cases in Singapore is still surging. Lian Hua Qing Wen Capsules (LH) was reported to have effective inhibitory action on Delta SARS-CoV-2 in-vitro. Due to limited availability and prioritisation of approved anti-viral drugs (Paxlovid) to moderate and severe inpatients, validating Traditional Chinese Medicine (TCM) intervention LH as a good adjuvant treatment for local population on home recovery program is important.

Objectives This research aims to investigate the adjuvant effect of LH in reducing the symptomatic duration of fully vaccinated, mild COVID-19 patients on home recovery program in Singapore. It is aimed to assist policymakers in incorporating clinically proven TCM treatment for mild COVID-19 patients on home recovery program, and establishing a guideline on TCM pandemic treatment protocol which is suitable to be integrated into the healthcare system.

Hypothesis The investigators hypothesize TCM intervention could shorten (1) the time of 8 major clinical symptoms of COVID-19 to no symptoms and (2) lesser days to COVID-19 Antigen Rapid Test (ART) negativity by 1.5 times in mild COVID-19 patients on home recovery program.

Methods 300 eligible participants will be enrolled. Equal number of participants will be randomised and double blinded in the two arms of placebo control and LH, both with standard care. Communication and consultation will be conducted through telecommunication. Primary outcome measures time to no symptoms. Secondary outcomes measure days to ART negativity, symptom severity scores and risk ratio. Exploratory outcomes include days of TCM Excess syndromes (symptoms caused by pathogenic factors) will be collated.

Significance Adjuvant treatment of mild COVID-19 patients can shorten symptomatic duration, slow disease progression, mitigate post-isolation COVID-19 symptoms, and allow isolated individuals to return to the community earlier.

Conditions
COVID-19
Being tested
TCM intervention, Placebo intervention
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TCM interventionOther

    Lian Hua Qing Wen Capsules (LH) are provided in addition to Standard Care medications which include Symptomatic therapies include Paracetamol, antihistamines (eg. Cetirizine, loratadine or chlorpheniramine) and etc pro re nata (PRN) basis accordingly to the patient's condition.

  • Placebo interventionOther

    Placebo Capsules (PC) are provided in addition to Standard Care medications which include Symptomatic therapies include Paracetamol, antihistamines (eg. Cetirizine, loratadine or chlorpheniramine) and etc pro re nata (PRN) basis accordingly to the patient's condition.

Study groups in NCT05275933
Study groupRoleWhat they receive
PC+SCPlacebo comparatorPlacebo Control Capsules (PC) are provided in addition to Standard Care medications
Receives: Other: Placebo intervention
LH+SCActive comparatorLian Hua Qing Wen Capsules (LH) are provided in addition to Standard Care medications.
Receives: Other: TCM intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1.1 Time (Days) to become asymptomatic (the event) for all 8 major COVID-19 symptoms.

    To document the adjuvant effect of LH on Symptom Severity Score within 7 days of enrolment in the PC + standard care and LH + standard care treatment at Day 1 to Day 7 every day.

    8 major Covid-19 symptoms: Stuffy or runny nose, Sore throat, Cough, Low energy or tiredness, Muscle or body aches, Headache, Chills or shivering, Feeling hot or feverish.

    The time (days) to become asymptomatic (the event) is defined as when all the 8 major Covid-19 symptoms meet the criteria of disappearing (score 0) and are stable for at least 24 hours.

    Measured: up to 7 days after enrolment

Secondary outcomes (4)

  1. 2.1 Median Time to COVID-19 ART negativity

    Detection of SARS-CoV-2 viral proteins (antigens) in respiratory tract specimens using a standardised locally approved self-administering Antigen Rapid Test (ART) Kit of the same brand and model daily from Day 1 to Day 7.

    • Time to COVID-19 ART negativity (the event) will be recorded, and are ART negative for the next additional 2 days.

    Measured: up to 7 days after enrolment

  2. 2.2 Symptom Severity Score

    To investigate symptom recovery and mean reduction score (defined as absolute differences of the overall symptom severity scores from baseline day 1) comparison between 2 arms on days 1-7, 28 specifically.

    • Overall symptom severity score (added together) for the following symptoms will be calculated:
    • Stuffy or runny nose
    • Sore throat
    • Cough
    • Low energy/tiredness
    • Muscle/body aches
    • Headache
    • Chills/shivering
    • Fever/Feeling hot/feverish
    • Sense of smell
    • Sense of taste
    • The lower the score the less intensity the symptoms are. For each symptoms (with specific definitions), 0 point represents no symptoms, 1 point represent mild, 2 point represent moderate and 3 point represents severe.

    Measured: up to 7 days and on the 28th day after enrolment

  3. 2.3 Adverse Events

    To document observed cumulative incidence of adverse events including event that leads to early discontinuation of PC+SC or LH+SC.

    Incidence of serious adverse events including COVID-19 disease worsening requiring medical intervention and/or hospitalization within 28 days will also be recorded and reported.

    Measured: up to 7 days and on the 28th day after enrolment

  4. 2.4 Time to become asymptomatic (the event) for the 3 Covid-19 symptoms of interest

    The time (days) to become asymptomatic (the event) for the 3 major Covid-19 symptoms of Stuffy or runny nose, Sore throat and Cough and meet the criteria of disappearing (score 0) and are stable for at least 24 hours.

    Measured: up to 7 days after enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2022
  2. Study start5 Apr 2022
  3. Primary completion22 Nov 2023
  4. Study completion22 Nov 2023

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomised, double-blind, placebo-controlled study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05275933
Sponsor's protocol ID
SCHMI-2021-001
Status last verified
Dec 2022
First submitted
2 Mar 2022
Last updated
27 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TCM intervention in people with COVID-19, run by Singapore Chung Hwa Medical Institution at 2 sites in Singapore.

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 13 inclusion and 25 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 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

1.1 Time (Days) to become asymptomatic (the event) for all 8 major COVID-19 symptoms. (time frame: up to 7 days after enrolment). 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 NCT05275933.

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 27 Dec 2023.

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