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Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN) (Hesperidin)

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ClinicalTrials.gov Identifier: NCT04715932
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
Ingenew Pharmaceuticals Inc.
Information provided by (Responsible Party):
Montreal Heart Institute

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 diary that will be completed by participants throughout the study and by taking the oral temperature daily.

Condition or disease Intervention/treatment Phase
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 Drug: Hesperidin Drug: Placebo Phase 2

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 inclusion and no exclusion criteria will be randomized to receive either hesperidin 1000 mg once daily (q.d.)) or placebo (1:1 allocation ratio) for 14 days. Investigational drug will be delivered to the patients' homes with an electronic oral thermometer and a symptoms diary. Follow-up phone assessments will occur after 3, 7, 10, and 14 days following randomization for evaluation of COVID-19 symptoms. Electronic Case Report Form (eCRF) will be completed by the research personnel over the phone with the patients. The symptoms diary will be mailed back to the coordinating center at the end of the study in a pre-addressed envelope.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Hesperidin Therapy on COVID-19 Symptoms: The Hesperidin Coronavirus Study (Hesperidin)
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Active Comparator: Hesperidin 1000mg
Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
Drug: Hesperidin
Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.

Placebo Comparator: Placebo 1000mg
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
Drug: Placebo
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.




Primary Outcome Measures :
  1. Proportion of subjects with COVID-19 symptoms. [ Time Frame: Change in symptoms from baseline, 3 days, 7 days, 10 days and 14 days ]
    Proportion of subjects with any of the following COVID-19 symptoms: fever, cough, shortness of breath or anosmia, at day 3, 7, 10 and 14.


Secondary Outcome Measures :
  1. Mean number of COVID-19 symptoms. [ Time Frame: Change in symptoms from baseline, 3 days, 7 days, 10 days and 14 days ]
    Mean number of COVID-19 symptoms (range 0-13) at day 3, 7, 10 and 14.

  2. Duration of COVID-19 symptoms. [ Time Frame: Change in symptoms from baseline, 3 days, 7 days, 10 days and 14 days ]
    Duration of COVID-19 symptoms, defined as the number of days between first symptoms and complete disappearance of any symptom.

  3. For each COVID-19 symptom listed in the appendix, proportion of subjects with the symptom. [ Time Frame: Change in symptoms from baseline, 3 days, 7 days, 10 days and 14 days ]
    For each COVID-19 symptom listed (recent couch or aggravation of chronic cough, fever, chills, sore throat, runny nose, shortness of breath, nausea, vomiting, headache, general weakness, pain, irritability, confusion, diarrhea, anosmia) , proportion of subjects with the symptom at day 3, 7, 10 and 14.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Covid-19 positive by polymerase chain reaction (PCR) testing or by confirmed epidemiological link (as defined by public health services at the time of inclusion);
  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715932


Contacts
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Contact: Jocelyn Dupuis, MD 514-376-3330 ext 3542 dupuisj@icloud.com
Contact: Josée Michaud, PhD 514-461-1300 ext 4040 josee.michaud@mhicc.org

Locations
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Canada, Quebec
Montreal Heart Institute Recruiting
Montréal, Quebec, Canada, H1T1C8
Contact: Jocelyn Dupuis, MD         
Principal Investigator: Jocelyn Dupuis, MD         
Sponsors and Collaborators
Montreal Heart Institute
Ingenew Pharmaceuticals Inc.
Investigators
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Principal Investigator: Jocelyn Dupuis, MD Montreal Heart Institute
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Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT04715932    
Other Study ID Numbers: MHICC-2020-003
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Arthralgia
Myalgia
Pharyngitis
Dyspnea
Confusion
Headache
Vomiting
Chest Pain
Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Nervous System Diseases
Pathologic Processes
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurobehavioral Manifestations
Respiration Disorders
Signs and Symptoms, Respiratory
Joint Diseases
Neuromuscular Diseases
Musculoskeletal Pain