Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT04715932
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04715932
Study Brief:
Protocol Section:
NCT04715932