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

NCT ID: NCT04715932

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-18
• Study Completion Date: 2021-06-07

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.

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Hesperidin

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ingenew Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: collaborator

Montreal Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jocelyn Dupuis, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Locations

Montreal Heart Institute

Montreal, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MHICC-2020-003

Identifier Type: -

Identifier Source: org_study_id