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

February 2, 2021 updated by: Dr. Pradip Gyanwali,MD, Nepal Health Research Council

A Randomized, Open-labelled and Controlled Clinical Trial to Investigate the Clinical Efficacy of Isoquercetin in the Treatment of Mild-to-moderate Hospitalised COVID-19 Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control arm
In this arm subjects will receive the hospital COVID-19 standard care
Drug: Hospital standard of care for COVID-19
Standard care for COVID-19 as per the hospital guidelines
Experimental: Isoquercetin arm
In this arm subjects will receive the hospital COVID-19 standard care + Isoquercetin
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Disease progression, defined as WHO Clinical Progression Scale score of ≥ 6, at any time from day 1 to day 28
Time Frame: From day 1 to day 28
From day 1 to day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Disease recovery, defined as WHO Progression Scale score of ≤ 2, at day 28
Time Frame: Day 1 through Day 28
Day 1 through Day 28

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change in the WHO Progression Scale score from baseline
Time Frame: Day 1 through Day 28
Day 1 through Day 28
Changes in daily breathlessness, cough and sputum scale (BCSS) score (including disaggregated scores)
Time Frame: Day 1 through Day 28
Day 1 through Day 28
Percentage of patients who progress to require mechanical ventilation
Time Frame: Day 1 through Day 28
Day 1 through Day 28
Percentage of patients admitted to intensive care unit admission
Time Frame: Day 1 through Day 28
Day 1 through Day 28
Time to recovery
Time Frame: Day 1 through Day 28
Day 1 through Day 28
Time to hospital discharge
Time Frame: Day 1 through Day 28
Day 1 through Day 28
Change in National Early Warning Score (NEWS 2) from baseline
Time Frame: Day 1 through Day 28
Day 1 through Day 28
All-cause mortality
Time Frame: Day 1 through Day 28
Day 1 through Day 28
QoL (EQ-5D-5L respiratory questionnaire)
Time Frame: Day 1 through Day 28
Day 1 through Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nepal Health Research Council

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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