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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Abdominal Pain
  • Anosmia
  • Arthralgia
  • Chest Pain
  • Confusion
  • Cough
  • COVID-19
  • Covid19
  • Dyspnea
  • Fever
  • Headache
  • Irritable Mood
  • Muscle Weakness
  • Myalgia
  • Nausea
  • Pain
  • Pain, Abdominal
  • Pain, Chest
  • Pain, Joint
  • Pain, Muscle
  • Pharyngitis
  • Shortness of Breath
  • Sore Throat
  • Vomiting

NCT number NCT04715932
Study type Interventional
Source Montreal Heart Institute
Contact
Status Completed
Phase Phase 2
Start date February 18, 2021
Completion date June 7, 2021

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