Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN) (Hesperidin)

April 6, 2022 updated by: Montreal Heart Institute

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Hesperidin Therapy on COVID-19 Symptoms: The Hesperidin Coronavirus Study (Hesperidin)

The main aim of this study is to determine the effects of short-term treatment with hesperidin on COVID-19 symptoms in comparison with a placebo. Treatment effects will be observed through a symptoms diary that will be completed by participants throughout the study and by taking the oral temperature daily.

Study Overview

Status

Status

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

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 will be a randomized, double-blind, placebo-controlled study. The study will include subjects from Quebec diagnosed with COVID-19 infections. Following informed consent, 216 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either hesperidin 1000 mg once daily (q.d.)) or placebo (1:1 allocation ratio) for 14 days. Investigational drug will be delivered to the patients' homes with an electronic oral thermometer and a symptoms diary. Follow-up phone assessments will occur after 3, 7, 10, and 14 days following randomization for evaluation of COVID-19 symptoms. Electronic Case Report Form (eCRF) will be completed by the research personnel over the phone with the patients. The symptoms diary will be mailed back to the coordinating center at the end of the study in a pre-addressed envelope.

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 (Actual)

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.
216

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 Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T1C8
        • Montreal Heart Institute

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Covid-19 positive by polymerase chain reaction (PCR) testing;
  • Participant must be able to evaluate their symptoms and report them in the symptoms diary;
  • Patients must be able to take their oral temperature daily with an electronic thermometer provided to them with study materials;
  • Males and females, at least 18 years of age, capable and willing to provide informed consent;
  • Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study;
  • Patient must have received a diagnosis of COVID-19 infection within the last 48 hours and have one or more symptoms;
  • Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization);
  • Patient must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

  • Patient currently hospitalized or under immediate consideration for hospitalization;
  • Patient currently in shock or with hemodynamic instability;
  • Patient undergoing chemotherapy for cancer;
  • Patient is unable to take oral temperature using an electronic thermometer;
  • Patient who received at least one dose of the COVID-19 vaccine;
  • Female patient who is pregnant or breast-feeding or is considering becoming pregnant during the study;
  • People taking anticoagulant/antiplatelet medications, those with bleeding disorders, and people two weeks before or after surgery;
  • Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study;
  • Regular consumption of natural products containing more than 150 mg of hesperidin or regular consumption of more than 1 glass of orange juice per day;
  • Known allergy to any of the medicinal and non-medicinal ingredient: hesperidin, microcrystalline cellulose, magnesium stearate.

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: Quadruple

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: Hesperidin 1000mg
Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
Drug: Hesperidin
Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
Placebo Comparator: Placebo 1000mg
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
Drug: Placebo
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.

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
Measure Description
Time Frame
Number of Subjects With COVID-19 Symptoms at Day 3.
Time Frame: Day 3
Number of subjects with any of the following COVID-19 symptoms: fever (temperature > 38 degrees), cough, shortness of breath or anosmia, at day 3.
Day 3
Number of Subjects With COVID-19 Symptoms at Day 7.
Time Frame: Day 7
Number of subjects with any of the following COVID-19 symptoms: fever (temperature > 38 degrees), cough, shortness of breath or anosmia, at day 7.
Day 7
Number of Subjects With COVID-19 Symptoms at Day 10.
Time Frame: Day 10
Number of subjects with any of the following COVID-19 symptoms: fever (temperature > 38 degrees), cough, shortness of breath or anosmia, at day 10.
Day 10
Number of Subjects With COVID-19 Symptoms at Day 14.
Time Frame: Day 14
Number of subjects with any of the following COVID-19 symptoms: fever (temperature > 38 degrees), cough, shortness of breath or anosmia, at day 14.
Day 14

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
Measure Description
Time Frame
Mean Number of COVID-19 Symptoms at Day 3.
Time Frame: Day 3
Mean number of COVID-19 symptoms (range 0-13) at day 3.
Day 3
Mean Number of COVID-19 Symptoms at Day 7.
Time Frame: Day 7
Mean number of COVID-19 symptoms (range 0-13) at day 7.
Day 7
Mean Number of COVID-19 Symptoms at Day 10.
Time Frame: Day 10
Mean number of COVID-19 symptoms (range 0-13) at day 10.
Day 10
Mean Number of COVID-19 Symptoms at Day 14.
Time Frame: Day 14
Mean number of COVID-19 symptoms (range 0-13) at day 14.
Day 14
Number of Subjects With Complete Disappearance of Any Symptom.
Time Frame: From randomization to occurence of first event, assessed up to 14 days
The descriptive statistics are the number of participants having complete disappearance of any symptom.
From randomization to occurence of first event, assessed up to 14 days
Number of Subjects With the Cough Symptom.
Time Frame: Day 3
Number of subjects with the cough symptom at day 3.
Day 3
Number of Subjects With the Cough Symptom.
Time Frame: Day 7
Number of subjects with the cough symptom at day 7.
Day 7
Number of Subjects With the Cough Symptom.
Time Frame: Day 10
Number of subjects with the cough symptom at day 10.
Day 10
Number of Subjects With the Cough Symptom.
Time Frame: Day 14
Number of subjects with the cough symptom at day 14.
Day 14
Number of Subjects With the Presence of Fever.
Time Frame: Day 3
Number of subjects with the presence of fever (temperature > 38 degrees) at day 3.
Day 3
Number of Subjects With the Presence of Fever.
Time Frame: Day 7
Number of subjects with the presence of fever (temperature > 38 degrees) at day 7.
Day 7
Number of Subjects With the Presence of Fever.
Time Frame: Day 10
Number of subjects with the presence of fever (temperature > 38 degrees) at day 10.
Day 10
Number of Subjects With the Presence of Fever.
Time Frame: Day 14
Number of subjects with the presence of fever (temperature > 38 degrees) at day 14.
Day 14
Number of Subjects With the Presence of Shortness of Breath.
Time Frame: Day 3
Number of subjects with the presence of shortness of breath at day 3.
Day 3
Number of Subjects With the Presence of Shortness of Breath.
Time Frame: Day 7
Number of subjects with the presence of shortness of breath at day 7.
Day 7
Number of Subjects With the Presence of Shortness of Breath.
Time Frame: Day 10
Number of subjects with the presence of shortness of breath at day 10.
Day 10
Number of Subjects With the Presence of Shortness of Breath.
Time Frame: Day 14
Number of subjects with the presence of shortness of breath at day 14.
Day 14
Number of Subjects With the Presence of Anosmia.
Time Frame: Day 3
Number of subjects with the presence of anosmia at day 3.
Day 3
Number of Subjects With the Presence of Anosmia.
Time Frame: Day 7
Number of subjects with the presence of anosmia at day 7.
Day 7
Number of Subjects With the Presence of Anosmia.
Time Frame: Day 10
Number of subjects with the presence of anosmia at day 10.
Day 10
Number of Subjects With the Presence of Anosmia.
Time Frame: Day 14
Number of subjects with the presence of anosmia at day 14.
Day 14
Number of Subjects With the Presence of Feverish or Chills.
Time Frame: Day 3
Number of subjects with the presence of feverish or chills at day 3.
Day 3
Number of Subjects With the Presence of Feverish or Chills.
Time Frame: Day 7
Number of subjects with the presence of feverish or chills at day 7.
Day 7
Number of Subjects With the Presence of Feverish or Chills.
Time Frame: Day 10
Number of subjects with the presence of feverish or chills at day 10.
Day 10
Number of Subjects With the Presence of Feverish or Chills.
Time Frame: Day 14
Number of subjects with the presence of feverish or chills at day 14.
Day 14
Number of Subjects With the Presence of Sore Throat.
Time Frame: Day 3
Number of subjects with the presence of sore throat at day 3.
Day 3
Number of Subjects With the Presence of Sore Throat.
Time Frame: Day 7
Number of subjects with the presence of sore throat at day 7.
Day 7
Number of Subjects With the Presence of Sore Throat.
Time Frame: Day 10
Number of subjects with the presence of sore throat at day 10.
Day 10
Number of Subjects With the Presence of Sore Throat.
Time Frame: Day 14
Number of subjects with the presence of sore throat at day 14.
Day 14
Number of Subjects With the Presence of Runny Nose.
Time Frame: Day 3
Number of subjects with the presence of runny nose at day 3.
Day 3
Number of Subjects With the Presence of Runny Nose.
Time Frame: Day 7
Number of subjects with the presence of runny nose at day 7.
Day 7
Number of Subjects With the Presence of Runny Nose.
Time Frame: Day 10
Number of subjects with the presence of runny nose at day 10.
Day 10
Number of Subjects With the Presence of Runny Nose.
Time Frame: Day 14
Number of subjects with the presence of runny nose at day 14.
Day 14
Number of Subjects With the Presence of Nausea/Vomiting.
Time Frame: Day 3
Number of subjects with the presence of nausea/vomiting at day 3.
Day 3
Number of Subjects With the Presence of Nausea/Vomiting.
Time Frame: Day 7
Number of subjects with the presence of nausea/vomiting at day 7.
Day 7
Number of Subjects With the Presence of Nausea/Vomiting.
Time Frame: Day 10
Number of subjects with the presence of nausea/vomiting at day 10.
Day 10
Number of Subjects With the Presence of Nausea/Vomiting.
Time Frame: Day 14
Number of subjects with the presence of nausea/vomiting at day 14.
Day 14
Number of Subjects With the Presence of Headache.
Time Frame: Day 3
Number of subjects with the presence of headache at day 3.
Day 3
Number of Subjects With the Presence of Headache.
Time Frame: Day 7
Number of subjects with the presence of headache at day 7.
Day 7
Number of Subjects With the Presence of Headache.
Time Frame: Day 10
Number of subjects with the presence of headache at day 10.
Day 10
Number of Subjects With the Presence of Headache.
Time Frame: Day 14
Number of subjects with the presence of headache at day 14.
Day 14
Number of Subjects With the Presence of General Weakness.
Time Frame: Day 3
Number of subjects with the presence of general weakness at day 3.
Day 3
Number of Subjects With the Presence of General Weakness.
Time Frame: Day 7
Number of subjects with the presence of general weakness at day 7.
Day 7
Number of Subjects With the Presence of General Weakness.
Time Frame: Day 10
Number of subjects with the presence of general weakness at day 10.
Day 10
Number of Subjects With the Presence of General Weakness.
Time Frame: Day 14
Number of subjects with the presence of general weakness at day 14.
Day 14
Number of Subjects With the Presence of Pain.
Time Frame: Day 3
Number of subjects with the presence of pain at day 3.
Day 3
Number of Subjects With the Presence of Pain.
Time Frame: Day 7
Number of subjects with the presence of pain at day 7.
Day 7
Number of Subjects With the Presence of Pain.
Time Frame: Day 10
Number of subjects with the presence of pain at day 10.
Day 10
Number of Subjects With the Presence of Pain.
Time Frame: Day 14
Number of subjects with the presence of pain at day 14.
Day 14
Number of Subjects With the Presence of Irritability/Confusion.
Time Frame: Day 3
Number of subjects with the presence of irritability/confusion at day 3.
Day 3
Number of Subjects With the Presence of Irritability/Confusion.
Time Frame: Day 7
Number of subjects with the presence of irritability/confusion at day 7.
Day 7
Number of Subjects With the Presence of Irritability/Confusion.
Time Frame: Day 10
Number of subjects with the presence of irritability/confusion at day 10.
Day 10
Number of Subjects With the Presence of Irritability/Confusion.
Time Frame: Day 14
Number of subjects with the presence of irritability/confusion at day 14.
Day 14
Number of Subjects With the Presence of Diarrhea.
Time Frame: Day 3
Number of subjects with the presence of diarrhea at day 3.
Day 3
Number of Subjects With the Presence of Diarrhea.
Time Frame: Day 7
Number of subjects with the presence of diarrhea at day 7.
Day 7
Number of Subjects With the Presence of Diarrhea.
Time Frame: Day 10
Number of subjects with the presence of diarrhea at day 10.
Day 10
Number of Subjects With the Presence of Diarrhea.
Time Frame: Day 14
Number of subjects with the presence of diarrhea at day 14.
Day 14

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.
Montreal Heart Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ingenew Pharmaceuticals Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jocelyn Dupuis, MD, Montreal Heart Institute

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 (Actual)

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 18, 2021

Primary Completion (Actual)

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 25, 2021

Study Completion (Actual)

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.
June 7, 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 15, 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.
January 19, 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.
January 20, 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.
April 8, 2022

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.
April 6, 2022

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.
April 1, 2022

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.
  • MHICC-2020-003

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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