Study to Investigate the Clinical Efficacy of Isoquercetin in Patients With COVID-19

NCT04733651 | Unknown Phase 2 DMC

• 1 other identifier: 22-2021
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Disease progression, defined as WHO Clinical Progression Scale score of ≥ 6, at any time from day 1 to day 28

  From day 1 to day 28

Secondary Outcomes (1)

• Disease recovery, defined as WHO Progression Scale score of ≤ 2, at day 28

  Day 1 through Day 28

Other Outcomes (9)

• Change in the WHO Progression Scale score from baseline

  Day 1 through Day 28

• Changes in daily breathlessness, cough and sputum scale (BCSS) score (including disaggregated scores)

  Day 1 through Day 28

• Percentage of patients who progress to require mechanical ventilation

  Day 1 through Day 28

Study Arms (2)

Control arm

ACTIVE COMPARATOR

In this arm subjects will receive the hospital COVID-19 standard care

Drug: Hospital standard of care for COVID-19

Isoquercetin arm

EXPERIMENTAL

In this arm subjects will receive the hospital COVID-19 standard care + Isoquercetin

Drug: Hospital standard of care for COVID-19; Drug: Isoquercetin

Interventions

Hospital standard of care for COVID-19 DRUG

Standard care for COVID-19 as per the hospital guidelines

Control arm; Isoquercetin arm

Isoquercetin DRUG

Daily 1000 mg Isoquercetin as 4 capsules

Isoquercetin arm

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years and above.
• 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.
• 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).
• WHO 10-point Clinical Progression Scale score of 4 to 5
• Patient requires hospitalisation due to severity of COVID-19 or comorbidities if score 3 on the WHO 10-point Clinical Progression Scale.
• Frailty score of ≤6.
• Patient able to provide informed consent.
• 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.

You may not qualify if:

• 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)
• Hospitalisation for reasons other than severity of COVID-19 or comorbidities (e.g. social reasons, local policies, isolation/quarantine).
• Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer).
• History of significant haemorrhage (requiring hospitalisation or transfusion) outside of a surgical setting within the last 24 months.
• Familial bleeding diathesis.
• Glucose-6-phosphate dehydrogenase deficiency.
• Severe hepatic and renal impairment as no safety and PK data of isoquercetin are available in these populations.
• 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).
• Concomitant use of Cyclosporine, Warfarin (Coumarin), TPA, strong inducer of CYP3A4, or substrate of CYP3A4 with narrow therapeutic index.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to isoquercetin.

Sponsors & Collaborators

• Nepal Health Research Council: lead

MeSH Terms

Conditions

COVID-19

Interventions

isoquercitrin

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

Central Study Contacts

Dr. Suman Pant, MD/MBBS

CONTACT

0977-14254220; suman.p@fph.tu.ac.th

Dr. Bikal Shrestha, MD/MBBS

CONTACT

0977-984-1262421; bikalshrestha@naihs.edu.np

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 2, 2021
• Study Start: February 20, 2021
• Primary Completion: May 20, 2021
• Study Completion: August 15, 2021
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share