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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04715932
Recruitment Status : Completed
First Posted : January 20, 2021
Results First Posted : April 8, 2022
Last Update Posted : April 8, 2022
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)
Actual 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
Actual Primary Completion Date : May 25, 2021
Actual Study Completion Date : June 7, 2021

Resource links provided by the National Library of Medicine


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. Number of Subjects With COVID-19 Symptoms at Day 3. [ Time Frame: Day 3 ]
    Number of subjects with any of the following COVID-19 symptoms: fever (temperature > 38 degrees), cough, shortness of breath or anosmia, at day 3.

  2. Number of Subjects With COVID-19 Symptoms at Day 7. [ Time Frame: Day 7 ]
    Number of subjects with any of the following COVID-19 symptoms: fever (temperature > 38 degrees), cough, shortness of breath or anosmia, at day 7.

  3. Number of Subjects With COVID-19 Symptoms at Day 10. [ Time Frame: Day 10 ]
    Number of subjects with any of the following COVID-19 symptoms: fever (temperature > 38 degrees), cough, shortness of breath or anosmia, at day 10.

  4. Number of Subjects With COVID-19 Symptoms at Day 14. [ Time Frame: Day 14 ]
    Number of subjects with any of the following COVID-19 symptoms: fever (temperature > 38 degrees), cough, shortness of breath or anosmia, at day 14.


Secondary Outcome Measures :
  1. Mean Number of COVID-19 Symptoms at Day 3. [ Time Frame: Day 3 ]
    Mean number of COVID-19 symptoms (range 0-13) at day 3.

  2. Mean Number of COVID-19 Symptoms at Day 7. [ Time Frame: Day 7 ]
    Mean number of COVID-19 symptoms (range 0-13) at day 7.

  3. Mean Number of COVID-19 Symptoms at Day 10. [ Time Frame: Day 10 ]
    Mean number of COVID-19 symptoms (range 0-13) at day 10.

  4. Mean Number of COVID-19 Symptoms at Day 14. [ Time Frame: Day 14 ]
    Mean number of COVID-19 symptoms (range 0-13) at day 14.

  5. Number of Subjects With Complete Disappearance of Any Symptom. [ Time Frame: From randomization to occurence of first event, assessed up to 14 days ]
    The descriptive statistics are the number of participants having complete disappearance of any symptom.

  6. Number of Subjects With the Cough Symptom. [ Time Frame: Day 3 ]
    Number of subjects with the cough symptom at day 3.

  7. Number of Subjects With the Cough Symptom. [ Time Frame: Day 7 ]
    Number of subjects with the cough symptom at day 7.

  8. Number of Subjects With the Cough Symptom. [ Time Frame: Day 10 ]
    Number of subjects with the cough symptom at day 10.

  9. Number of Subjects With the Cough Symptom. [ Time Frame: Day 14 ]
    Number of subjects with the cough symptom at day 14.

  10. Number of Subjects With the Presence of Fever. [ Time Frame: Day 3 ]
    Number of subjects with the presence of fever (temperature > 38 degrees) at day 3.

  11. Number of Subjects With the Presence of Fever. [ Time Frame: Day 7 ]
    Number of subjects with the presence of fever (temperature > 38 degrees) at day 7.

  12. Number of Subjects With the Presence of Fever. [ Time Frame: Day 10 ]
    Number of subjects with the presence of fever (temperature > 38 degrees) at day 10.

  13. Number of Subjects With the Presence of Fever. [ Time Frame: Day 14 ]
    Number of subjects with the presence of fever (temperature > 38 degrees) at day 14.

  14. Number of Subjects With the Presence of Shortness of Breath. [ Time Frame: Day 3 ]
    Number of subjects with the presence of shortness of breath at day 3.

  15. Number of Subjects With the Presence of Shortness of Breath. [ Time Frame: Day 7 ]
    Number of subjects with the presence of shortness of breath at day 7.

  16. Number of Subjects With the Presence of Shortness of Breath. [ Time Frame: Day 10 ]
    Number of subjects with the presence of shortness of breath at day 10.

  17. Number of Subjects With the Presence of Shortness of Breath. [ Time Frame: Day 14 ]
    Number of subjects with the presence of shortness of breath at day 14.

  18. Number of Subjects With the Presence of Anosmia. [ Time Frame: Day 3 ]
    Number of subjects with the presence of anosmia at day 3.

  19. Number of Subjects With the Presence of Anosmia. [ Time Frame: Day 7 ]
    Number of subjects with the presence of anosmia at day 7.

  20. Number of Subjects With the Presence of Anosmia. [ Time Frame: Day 10 ]
    Number of subjects with the presence of anosmia at day 10.

  21. Number of Subjects With the Presence of Anosmia. [ Time Frame: Day 14 ]
    Number of subjects with the presence of anosmia at day 14.

  22. Number of Subjects With the Presence of Feverish or Chills. [ Time Frame: Day 3 ]
    Number of subjects with the presence of feverish or chills at day 3.

  23. Number of Subjects With the Presence of Feverish or Chills. [ Time Frame: Day 7 ]
    Number of subjects with the presence of feverish or chills at day 7.

  24. Number of Subjects With the Presence of Feverish or Chills. [ Time Frame: Day 10 ]
    Number of subjects with the presence of feverish or chills at day 10.

  25. Number of Subjects With the Presence of Feverish or Chills. [ Time Frame: Day 14 ]
    Number of subjects with the presence of feverish or chills at day 14.

  26. Number of Subjects With the Presence of Sore Throat. [ Time Frame: Day 3 ]
    Number of subjects with the presence of sore throat at day 3.

  27. Number of Subjects With the Presence of Sore Throat. [ Time Frame: Day 7 ]
    Number of subjects with the presence of sore throat at day 7.

  28. Number of Subjects With the Presence of Sore Throat. [ Time Frame: Day 10 ]
    Number of subjects with the presence of sore throat at day 10.

  29. Number of Subjects With the Presence of Sore Throat. [ Time Frame: Day 14 ]
    Number of subjects with the presence of sore throat at day 14.

  30. Number of Subjects With the Presence of Runny Nose. [ Time Frame: Day 3 ]
    Number of subjects with the presence of runny nose at day 3.

  31. Number of Subjects With the Presence of Runny Nose. [ Time Frame: Day 7 ]
    Number of subjects with the presence of runny nose at day 7.

  32. Number of Subjects With the Presence of Runny Nose. [ Time Frame: Day 10 ]
    Number of subjects with the presence of runny nose at day 10.

  33. Number of Subjects With the Presence of Runny Nose. [ Time Frame: Day 14 ]
    Number of subjects with the presence of runny nose at day 14.

  34. Number of Subjects With the Presence of Nausea/Vomiting. [ Time Frame: Day 3 ]
    Number of subjects with the presence of nausea/vomiting at day 3.

  35. Number of Subjects With the Presence of Nausea/Vomiting. [ Time Frame: Day 7 ]
    Number of subjects with the presence of nausea/vomiting at day 7.

  36. Number of Subjects With the Presence of Nausea/Vomiting. [ Time Frame: Day 10 ]
    Number of subjects with the presence of nausea/vomiting at day 10.

  37. Number of Subjects With the Presence of Nausea/Vomiting. [ Time Frame: Day 14 ]
    Number of subjects with the presence of nausea/vomiting at day 14.

  38. Number of Subjects With the Presence of Headache. [ Time Frame: Day 3 ]
    Number of subjects with the presence of headache at day 3.

  39. Number of Subjects With the Presence of Headache. [ Time Frame: Day 7 ]
    Number of subjects with the presence of headache at day 7.

  40. Number of Subjects With the Presence of Headache. [ Time Frame: Day 10 ]
    Number of subjects with the presence of headache at day 10.

  41. Number of Subjects With the Presence of Headache. [ Time Frame: Day 14 ]
    Number of subjects with the presence of headache at day 14.

  42. Number of Subjects With the Presence of General Weakness. [ Time Frame: Day 3 ]
    Number of subjects with the presence of general weakness at day 3.

  43. Number of Subjects With the Presence of General Weakness. [ Time Frame: Day 7 ]
    Number of subjects with the presence of general weakness at day 7.

  44. Number of Subjects With the Presence of General Weakness. [ Time Frame: Day 10 ]
    Number of subjects with the presence of general weakness at day 10.

  45. Number of Subjects With the Presence of General Weakness. [ Time Frame: Day 14 ]
    Number of subjects with the presence of general weakness at day 14.

  46. Number of Subjects With the Presence of Pain. [ Time Frame: Day 3 ]
    Number of subjects with the presence of pain at day 3.

  47. Number of Subjects With the Presence of Pain. [ Time Frame: Day 7 ]
    Number of subjects with the presence of pain at day 7.

  48. Number of Subjects With the Presence of Pain. [ Time Frame: Day 10 ]
    Number of subjects with the presence of pain at day 10.

  49. Number of Subjects With the Presence of Pain. [ Time Frame: Day 14 ]
    Number of subjects with the presence of pain at day 14.

  50. Number of Subjects With the Presence of Irritability/Confusion. [ Time Frame: Day 3 ]
    Number of subjects with the presence of irritability/confusion at day 3.

  51. Number of Subjects With the Presence of Irritability/Confusion. [ Time Frame: Day 7 ]
    Number of subjects with the presence of irritability/confusion at day 7.

  52. Number of Subjects With the Presence of Irritability/Confusion. [ Time Frame: Day 10 ]
    Number of subjects with the presence of irritability/confusion at day 10.

  53. Number of Subjects With the Presence of Irritability/Confusion. [ Time Frame: Day 14 ]
    Number of subjects with the presence of irritability/confusion at day 14.

  54. Number of Subjects With the Presence of Diarrhea. [ Time Frame: Day 3 ]
    Number of subjects with the presence of diarrhea at day 3.

  55. Number of Subjects With the Presence of Diarrhea. [ Time Frame: Day 7 ]
    Number of subjects with the presence of diarrhea at day 7.

  56. Number of Subjects With the Presence of Diarrhea. [ Time Frame: Day 10 ]
    Number of subjects with the presence of diarrhea at day 10.

  57. Number of Subjects With the Presence of Diarrhea. [ Time Frame: Day 14 ]
    Number of subjects with the presence of diarrhea at day 14.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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;
  • 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.

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


Locations
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Canada, Quebec
Montreal Heart Institute
Montréal, Quebec, Canada, H1T1C8
Sponsors and Collaborators
Montreal Heart Institute
Ingenew Pharmaceuticals Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jocelyn Dupuis, MD Montreal Heart Institute
  Study Documents (Full-Text)

Documents provided by Montreal Heart Institute:
Study Protocol  [PDF] February 17, 2021
Statistical Analysis Plan  [PDF] April 29, 2021
Informed Consent Form  [PDF] January 21, 2021

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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
Results First Posted: April 8, 2022
Last Update Posted: April 8, 2022
Last Verified: April 2022
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:
Layout table for MeSH terms
COVID-19
Pharyngitis
Muscle Weakness
Arthralgia
Myalgia
Dyspnea
Confusion
Anosmia
Headache
Vomiting
Chest Pain
Abdominal Pain
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Nervous System Diseases