Status:
COMPLETED
Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)
Lead Sponsor:
Montreal Heart Institute
Collaborating Sponsors:
Ingenew Pharmaceuticals Inc.
Conditions:
Covid19
Anosmia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2021
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04715932
Start Date
February 18 2021
End Date
June 7 2021
Last Update
April 8 2022
Active Locations (1)
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1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T1C8