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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
216
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.
Montreal Heart Institute
Montreal, Quebec, Canada
Number of Subjects With COVID-19 Symptoms at 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.
Time frame: Day 3
Number of Subjects With COVID-19 Symptoms at 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.
Time frame: Day 7
Number of Subjects With COVID-19 Symptoms at 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.
Time frame: Day 10
Number of Subjects With COVID-19 Symptoms at 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.
Time frame: Day 14
Mean Number of COVID-19 Symptoms at Day 3.
Mean number of COVID-19 symptoms (range 0-13) at day 3.
Time frame: Day 3
Mean Number of COVID-19 Symptoms at Day 7.
Mean number of COVID-19 symptoms (range 0-13) at day 7.
Time frame: Day 7
Mean Number of COVID-19 Symptoms at Day 10.
Mean number of COVID-19 symptoms (range 0-13) at day 10.
Time frame: Day 10
Mean Number of COVID-19 Symptoms at Day 14.
Mean number of COVID-19 symptoms (range 0-13) at day 14.
Time frame: Day 14
Number of Subjects With Complete Disappearance of Any Symptom.
The descriptive statistics are the number of participants having complete disappearance of any symptom.
Time frame: From randomization to occurence of first event, assessed up to 14 days
Number of Subjects With the Cough Symptom.
Number of subjects with the cough symptom at day 3.
Time frame: Day 3
Number of Subjects With the Cough Symptom.
Number of subjects with the cough symptom at day 7.
Time frame: Day 7
Number of Subjects With the Cough Symptom.
Number of subjects with the cough symptom at day 10.
Time frame: Day 10
Number of Subjects With the Cough Symptom.
Number of subjects with the cough symptom at day 14.
Time frame: Day 14
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 3.
Time frame: Day 3
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 7.
Time frame: Day 7
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 10.
Time frame: Day 10
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 14.
Time frame: Day 14
Number of Subjects With the Presence of Shortness of Breath.
Number of subjects with the presence of shortness of breath at day 3.
Time frame: Day 3
Number of Subjects With the Presence of Shortness of Breath.
Number of subjects with the presence of shortness of breath at day 7.
Time frame: Day 7
Number of Subjects With the Presence of Shortness of Breath.
Number of subjects with the presence of shortness of breath at day 10.
Time frame: Day 10
Number of Subjects With the Presence of Shortness of Breath.
Number of subjects with the presence of shortness of breath at day 14.
Time frame: Day 14
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 3.
Time frame: Day 3
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 7.
Time frame: Day 7
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 10.
Time frame: Day 10
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 14.
Time frame: Day 14
Number of Subjects With the Presence of Feverish or Chills.
Number of subjects with the presence of feverish or chills at day 3.
Time frame: Day 3
Number of Subjects With the Presence of Feverish or Chills.
Number of subjects with the presence of feverish or chills at day 7.
Time frame: Day 7
Number of Subjects With the Presence of Feverish or Chills.
Number of subjects with the presence of feverish or chills at day 10.
Time frame: Day 10
Number of Subjects With the Presence of Feverish or Chills.
Number of subjects with the presence of feverish or chills at day 14.
Time frame: Day 14
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 3.
Time frame: Day 3
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 7.
Time frame: Day 7
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 10.
Time frame: Day 10
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 14.
Time frame: Day 14
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 3.
Time frame: Day 3
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 7.
Time frame: Day 7
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 10.
Time frame: Day 10
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 14.
Time frame: Day 14
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 3.
Time frame: Day 3
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 7.
Time frame: Day 7
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 10.
Time frame: Day 10
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 14.
Time frame: Day 14
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 3.
Time frame: Day 3
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 7.
Time frame: Day 7
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 10.
Time frame: Day 10
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 14.
Time frame: Day 14
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 3.
Time frame: Day 3
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 7.
Time frame: Day 7
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 10.
Time frame: Day 10
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 14.
Time frame: Day 14
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 3.
Time frame: Day 3
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 7.
Time frame: Day 7
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 10.
Time frame: Day 10
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 14.
Time frame: Day 14
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 3.
Time frame: Day 3
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 7.
Time frame: Day 7
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 10.
Time frame: Day 10
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 14.
Time frame: Day 14
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 3.
Time frame: Day 3
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 7.
Time frame: Day 7
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 10.
Time frame: Day 10
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 14.
Time frame: Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.