Overview

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.