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

• Status: Completed
• Trial end date: 2021-06-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montreal Heart Institute
• Collaborator: Ingenew Pharmaceuticals Inc.

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.