The purpose of this study is to investigate the clinical efficacy of Isoquercetin in preventing disease progression and symptoms improvement in mild-to-moderate hospitalised COVID-19 patients.
This is an open-labelled, randomized and multi-centre clinical trial in subjects with RT-PCR
confirmed SARS-CoV-2 infection with mild-to-moderate symptoms, and who are currently admitted
to the hospital for diagnosis of COVID-19. The study has two arms: hospital standard COVID-19
care (Control group) and hospital standard COVID-19 care + Isoquercetin (Isoquercetin group).
The recruited subjects will be placed into either group by an electronic randomization
process. Patients in the Isoquercetin group will receive a daily dose of 1000 mg Isoquercetin
as 4 x 250 mg Isoquercetin capsules as add-on therapy in addition to the hospital standard
COVID-19 care. The Isoquercetin treatment will continue for 28 days.
Drug: Hospital standard of care for COVID-19
Standard care for COVID-19 as per the hospital guidelines
Drug: Isoquercetin
Daily 1000 mg Isoquercetin as 4 capsules
Inclusion Criteria:
1. Adults aged 18 years and above.
2. Confirmed SARS-CoV-2 infection by PCR/RT-PCR. Patients with positive point of care
tests can be randomised but have to be confirmed for SARS-CoV-2 by RT-PCR.
3. Presence of symptoms consistent with COVID-19 (e.g. shortness of breath, cough,
sputum, muscle aches, headache, fatigue, sore throat, loss or change to sense of smell
and/or taste, rhinorrhoea and anorexia).
4. WHO 10-point Clinical Progression Scale score of 4 to 5
5. Patient requires hospitalisation due to severity of COVID-19 or comorbidities if score
3 on the WHO 10-point Clinical Progression Scale.
6. Frailty score of ≤6.
7. Patient able to provide informed consent.
8. Females of child-bearing potential must be non-lactating, must have a negative
pregnancy test at Screening, and must agree to continue using contraception throughout
the study and for 4 weeks after study completion.
Exclusion Criteria:
1. Severe or critical COVID-19, e.g.:
- Respiratory rate ≥ 30 breaths per minute OR
- Heart rate ≥ 125 beats per minute OR
- Respiratory failure, defined as clinical need for high-flow oxygen therapy, non-
invasive positive pressure ventilation or endotracheal intubation and mechanical
ventilation OR
- Shock, defined as systolic blood pressure <90 mm Hg or diastolic blood pressure
<60 mm Hg or requiring vasopressors OR
- Multi-organ dysfunction/failure (WHO Clinical Progression Scale score ≥6)
2. Hospitalisation for reasons other than severity of COVID-19 or comorbidities (e.g.
social reasons, local policies, isolation/quarantine).
3. Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer).
4. History of significant haemorrhage (requiring hospitalisation or transfusion) outside
of a surgical setting within the last 24 months.
5. Familial bleeding diathesis.
6. Glucose-6-phosphate dehydrogenase deficiency.
7. Severe hepatic and renal impairment as no safety and PK data of isoquercetin are
available in these populations.
8. Current daily use of aspirin (> 81 mg daily), Clopidogrel (Plavix), cilostazol
(Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to use
regular use of higher doses of non-steroidal anti-inflammatory agents as determined by
the treating physician (e.g. ibuprofen > 800 mg daily or equivalent).
9. Concomitant use of Cyclosporine, Warfarin (Coumarin), TPA, strong inducer of CYP3A4,
or substrate of CYP3A4 with narrow therapeutic index.
10. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to isoquercetin.
11. Pregnancy.
12. Because there is an unknown but potential risk of adverse events in nursing infants
secondary to treatment of the mother with isoquercetin, breastfeeding should be
discontinued if the mother is treated with Isoquercetin. These potential risks may
also apply to other agents used in this study.
13. Known hypersensitivity to Isoquercetin, Quercetin, or to any of the excipients used in
the Isoquercetin capsules.
14. Patient with history of poor compliance, or current or past psychiatric disease that
might interfere with the ability to comply with the study procedures or give informed
consent according to the judgment of the investigator or institutionalized by court
decision.
15. Patient with any condition that the physician judges could be detrimental to patient
participating in this study.
Dr. Suman Pant, MD/MBBS
0977-14254220
suman.p@fph.tu.ac.th
Dr. Bikal Shrestha, MD/MBBS
0977-984-1262421
bikalshrestha@naihs.edu.np