Study to Investigate the Clinical Efficacy of Isoquercetin in Patients With COVID-19
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hospital standard of care for COVID-19
Isoquercetin
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control arm
Isoquercetin arm
Arm Description
In this arm subjects will receive the hospital COVID-19 standard care
In this arm subjects will receive the hospital COVID-19 standard care + Isoquercetin
Outcomes
Primary Outcome Measures
Disease progression, defined as WHO Clinical Progression Scale score of ≥ 6, at any time from day 1 to day 28
Secondary Outcome Measures
Disease recovery, defined as WHO Progression Scale score of ≤ 2, at day 28
Full Information
NCT ID
NCT04733651
First Posted
January 31, 2021
Last Updated
February 2, 2021
Sponsor
Nepal Health Research Council
1. Study Identification
Unique Protocol Identification Number
NCT04733651
Brief Title
Study to Investigate the Clinical Efficacy of Isoquercetin in Patients With COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2021 (Anticipated)
Primary Completion Date
May 20, 2021 (Anticipated)
Study Completion Date
August 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nepal Health Research Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
In this arm subjects will receive the hospital COVID-19 standard care
Arm Title
Isoquercetin arm
Arm Type
Experimental
Arm Description
In this arm subjects will receive the hospital COVID-19 standard care + Isoquercetin
Intervention Type
Drug
Intervention Name(s)
Hospital standard of care for COVID-19
Intervention Description
Standard care for COVID-19 as per the hospital guidelines
Intervention Type
Drug
Intervention Name(s)
Isoquercetin
Intervention Description
Daily 1000 mg Isoquercetin as 4 capsules
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Disease recovery, defined as WHO Progression Scale score of ≤ 2, at day 28
Time Frame
Day 1 through Day 28
Other Pre-specified Outcome Measures:
Title
Change in the WHO Progression Scale score from baseline
Time Frame
Day 1 through Day 28
Title
Changes in daily breathlessness, cough and sputum scale (BCSS) score (including disaggregated scores)
Time Frame
Day 1 through Day 28
Title
Percentage of patients who progress to require mechanical ventilation
Time Frame
Day 1 through Day 28
Title
Percentage of patients admitted to intensive care unit admission
Time Frame
Day 1 through Day 28
Title
Time to recovery
Time Frame
Day 1 through Day 28
Title
Time to hospital discharge
Time Frame
Day 1 through Day 28
Title
Change in National Early Warning Score (NEWS 2) from baseline
Time Frame
Day 1 through Day 28
Title
All-cause mortality
Time Frame
Day 1 through Day 28
Title
QoL (EQ-5D-5L respiratory questionnaire)
Time Frame
Day 1 through Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Suman Pant, MD/MBBS
Phone
0977-14254220
Email
suman.p@fph.tu.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Bikal Shrestha, MD/MBBS
Phone
0977-984-1262421
Email
bikalshrestha@naihs.edu.np
12. IPD Sharing Statement
Plan to Share IPD
No
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Study to Investigate the Clinical Efficacy of Isoquercetin in Patients With COVID-19
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