Trials / Completed
CompletedNCT04715932
Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)
A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Hesperidin Therapy on COVID-19 Symptoms: The Hesperidin Coronavirus Study (Hesperidin)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Montreal Heart Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2021-02-18
- Primary completion
- 2021-05-25
- Completion
- 2021-06-07
- First posted
- 2021-01-20
- Last updated
- 2022-04-08
- Results posted
- 2022-04-08
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04715932. Inclusion in this directory is not an endorsement.