Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN) (NCT04715932) | Clinical Trial Compass
CompletedPhase 2
Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)
Canada216 participantsStarted 2021-02-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Number of Subjects With COVID-19 Symptoms at Day 3.
Timeframe: Day 3
2
Number of Subjects With COVID-19 Symptoms at Day 7.
Timeframe: Day 7
3
Number of Subjects With COVID-19 Symptoms at Day 10.
Timeframe: Day 10
4
Number of Subjects With COVID-19 Symptoms at Day 14.