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

NCT04715932 | Completed Phase 2 Results

• 1 other identifier: MHICC-2020-003
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19; Anosmia; Fever; Cough; Shortness of Breath; Sore Throat; Nausea; Vomiting; Headache; Muscle Weakness; Pain, Muscle; Pain, Chest; Pain, Joint; Pain, Abdominal; Pain; Irritable Mood; Confusion

Outcome Measures

Primary Outcomes (4)

• Number of Subjects With COVID-19 Symptoms at 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.

  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.

  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.

  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 Outcomes (57)

• Mean Number of COVID-19 Symptoms at Day 3.

  Day 3

• Mean Number of COVID-19 Symptoms at Day 7.

  Day 7

• Mean Number of COVID-19 Symptoms at Day 10.

  Day 10

• Mean Number of COVID-19 Symptoms at Day 14.

  Day 14

• Number of Subjects With Complete Disappearance of Any Symptom.

  From randomization to occurence of first event, assessed up to 14 days

Study Arms (2)

Hesperidin 1000mg

ACTIVE COMPARATOR

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

Placebo 1000mg

PLACEBO COMPARATOR

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

Interventions

Hesperidin DRUG

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

Hesperidin 1000mg

Placebo DRUG

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

Placebo 1000mg

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Ingenew Pharmaceuticals Inc.: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

MeSH Terms

Conditions

COVID-19; Anosmia; Fever; Cough; Dyspnea; Pharyngitis; Nausea; Vomiting; Headache; Muscle Weakness; Myalgia; Chest Pain; Arthralgia; Abdominal Pain; Pain; Confusion

Interventions

Hesperidin

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; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Respiration Disorders; Signs and Symptoms, Respiratory; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Digestive; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathologic Processes; Neuromuscular Diseases; Musculoskeletal Pain; Joint Diseases; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Flavanones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates

Limitations and Caveats

Only one dosage regimen of hesperidin was tested in this trial.

Results Point of Contact

• Title: Dr Jocelyn Dupuis (Principal Investigator)
• Organization: Montreal Heart Institute

jocelyn.dupuis@icm-mhi.org

514 376-3330

Study Officials

• Jocelyn Dupuis, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 20, 2021
• Study Start: February 18, 2021
• Primary Completion: May 25, 2021
• Study Completion: June 7, 2021
• Last Updated: April 8, 2022
• Results First Posted: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)