Covid19Phase 2NCT04733651
Study to Investigate the Clinical Efficacy of Isoquercetin in Patients With COVID-19
A Phase 2 study testing Isoquercetin in people with Covid19, run by Nepal Health Research Council.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Isoquercetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2021to 15 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
- Pregnancy.
- 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.
- Known hypersensitivity to Isoquercetin, Quercetin, or to any of the excipients used in the Isoquercetin capsules.
- 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.
- Patient with any condition that the physician judges could be detrimental to patient participating in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Hospital standard of care for COVID-19, Isoquercetin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital standard of care for COVID-19Drug
Standard care for COVID-19 as per the hospital guidelines
IsoquercetinDrug
Daily 1000 mg Isoquercetin as 4 capsules
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | In this arm subjects will receive the hospital COVID-19 standard care Receives: Drug: Hospital standard of care for COVID-19 |
| Isoquercetin arm | Experimental | In this arm subjects will receive the hospital COVID-19 standard care + Isoquercetin Receives: Drug: Hospital standard of care for COVID-19; Drug: Isoquercetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression, defined as WHO Clinical Progression Scale score of ≥ 6, at any time from day 1 to day 28
Measured: From day 1 to day 28
Secondary outcomes (1)
Disease recovery, defined as WHO Progression Scale score of ≤ 2, at day 28
Measured: Day 1 through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start20 Feb 2021 (estimated)
- Primary completion20 May 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nepal Health Research Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Pradip Gyanwali,MD, Nepal Health Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733651
- Sponsor's protocol ID
- 22-2021
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04733651
- Acronym / sponsor ID
- 22-2021
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Nepal Health Research CouncilOther government
- Study start
- 20 Feb 2021 (estimated)
- Primary completion
- 20 May 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Drug: Hospital standard of care for COVID-19In this arm subjects will receive the hospital COVID-19 standard care |
| Isoquercetin arm | Experimental | Drug: Hospital standard of care for COVID-19, Drug: IsoquercetinIn this arm subjects will receive the hospital COVID-19 standard care + Isoquercetin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- Severe or critical COVID-19, e.g.:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital standard of care for COVID-19Standard care for COVID-19 as per the hospital guidelines | Drug | Control arm, Isoquercetin arm |
| IsoquercetinDaily 1000 mg Isoquercetin as 4 capsules | Drug | Isoquercetin arm |
Primary outcome
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
1 secondary outcome
Disease recovery, defined as WHO Progression Scale score of ≤ 2, at day 28
Time frame: Day 1 through Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isoquercetin in people with Covid19, run by Nepal Health Research Council.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Suman Pant, MD/MBBS (0977-14254220, suman.p@fph.tu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.