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

NCT05275933 | Completed Phase 2

• 1 other identifier: SCHMI-2021-001
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (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.

  up to 7 days after enrolment

Secondary Outcomes (4)

• 2.1 Median Time to COVID-19 ART negativity

  up to 7 days after enrolment

• 2.2 Symptom Severity Score

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

• 2.3 Adverse Events

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

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

  up to 7 days after enrolment

Other Outcomes (6)

• 3.1 Feasibility of recruitment

  6 months

• 3.2 Participation Rate

  6 months

• 3.3 Study agent compliance

  up to 28 days after enrolment

Study Arms (2)

PC+SC

PLACEBO COMPARATOR

Placebo Control Capsules (PC) are provided in addition to Standard Care medications

Other: Placebo intervention

LH+SC

ACTIVE COMPARATOR

Lian Hua Qing Wen Capsules (LH) are provided in addition to Standard Care medications.

Other: TCM intervention

Interventions

TCM intervention OTHER

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.

LH+SC

Placebo intervention OTHER

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.

PC+SC

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Singapore Chung Hwa Medical Institution: lead

Study Sites (2)

Ubi Family Clinic & Surgery

Singapore, 400305, Singapore

Location

Banyan clinic @ jw private limited

Singapore, 640502, Singapore

Location

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

• Sze Tat Ong, MBBS Hons

  Singapore Chung Hwa Medical Institution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: April 5, 2022
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: December 27, 2023

Record last verified: 2022-12

Locations

SG (2)