Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)
Condition: Covid19; Anosmia; Fever; Cough; Shortness of Breath; Sore Throat; Nausea; Vomiting; Headache; Muscle Weakness; Pain, Muscle; Pain, Chest; Pain, Joint; Pain, Abdominal; Pain; Irritable Mood; Confusion
MeSH terms: COVID-19; Pharyngitis; Muscle Weakness; Arthralgia; Myalgia; Dyspnea; Confusion; Anosmia; Vomiting; Chest Pain; Abdominal Pain
Intervention: Hesperidin; Placebo
Intervention description: Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.; Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.