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

Inclusion Criteria:

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

Exclusion Criteria:

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