Clinical trial NCT04715932: Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Hesperidin Therapy on COVID-19 Symptoms: The Hesperidin Coronavirus Study (Hesperidin)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Ingenew Pharmaceuticals Inc.
First posted: 2021-01-20
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Subjects With COVID-19 Symptoms at Day 3.
timeFrame: Day 3
measure: Number of Subjects With COVID-19 Symptoms at Day 7.
timeFrame: Day 7
measure: Number of Subjects With COVID-19 Symptoms at Day 10.
timeFrame: Day 10
measure: Number of Subjects With COVID-19 Symptoms at Day 14.
timeFrame: Day 14
Secondary outcomes:
measure: Mean Number of COVID-19 Symptoms at Day 3.
timeFrame: Day 3
measure: Mean Number of COVID-19 Symptoms at Day 7.
timeFrame: Day 7
measure: Mean Number of COVID-19 Symptoms at Day 10.
timeFrame: Day 10
measure: Mean Number of COVID-19 Symptoms at Day 14.
timeFrame: Day 14
measure: Number of Subjects With Complete Disappearance of Any Symptom.
timeFrame: From randomization to occurence of first event, assessed up to 14 days
measure: Number of Subjects With the Cough Symptom.
timeFrame: Day 3
measure: Number of Subjects With the Cough Symptom.
timeFrame: Day 7
measure: Number of Subjects With the Cough Symptom.
timeFrame: Day 10
measure: Number of Subjects With the Cough Symptom.
timeFrame: Day 14
measure: Number of Subjects With the Presence of Fever.
timeFrame: Day 3
measure: Number of Subjects With the Presence of Fever.
timeFrame: Day 7
measure: Number of Subjects With the Presence of Fever.
timeFrame: Day 10
measure: Number of Subjects With the Presence of Fever.
timeFrame: Day 14
measure: Number of Subjects With the Presence of Shortness of Breath.
timeFrame: Day 3
measure: Number of Subjects With the Presence of Shortness of Breath.
timeFrame: Day 7
measure: Number of Subjects With the Presence of Shortness of Breath.
timeFrame: Day 10
measure: Number of Subjects With the Presence of Shortness of Breath.
timeFrame: Day 14
measure: Number of Subjects With the Presence of Anosmia.
timeFrame: Day 3
measure: Number of Subjects With the Presence of Anosmia.
timeFrame: Day 7
measure: Number of Subjects With the Presence of Anosmia.
timeFrame: Day 10
measure: Number of Subjects With the Presence of Anosmia.
timeFrame: Day 14
measure: Number of Subjects With the Presence of Feverish or Chills.
timeFrame: Day 3
measure: Number of Subjects With the Presence of Feverish or Chills.
timeFrame: Day 7
measure: Number of Subjects With the Presence of Feverish or Chills.
timeFrame: Day 10
measure: Number of Subjects With the Presence of Feverish or Chills.
timeFrame: Day 14
measure: Number of Subjects With the Presence of Sore Throat.
timeFrame: Day 3
measure: Number of Subjects With the Presence of Sore Throat.
timeFrame: Day 7
measure: Number of Subjects With the Presence of Sore Throat.
timeFrame: Day 10
measure: Number of Subjects With the Presence of Sore Throat.
timeFrame: Day 14
measure: Number of Subjects With the Presence of Runny Nose.
timeFrame: Day 3
measure: Number of Subjects With the Presence of Runny Nose.
timeFrame: Day 7
measure: Number of Subjects With the Presence of Runny Nose.
timeFrame: Day 10
measure: Number of Subjects With the Presence of Runny Nose.
timeFrame: Day 14
measure: Number of Subjects With the Presence of Nausea/Vomiting.
timeFrame: Day 3
measure: Number of Subjects With the Presence of Nausea/Vomiting.
timeFrame: Day 7
measure: Number of Subjects With the Presence of Nausea/Vomiting.
timeFrame: Day 10
measure: Number of Subjects With the Presence of Nausea/Vomiting.
timeFrame: Day 14
measure: Number of Subjects With the Presence of Headache.
timeFrame: Day 3
measure: Number of Subjects With the Presence of Headache.
timeFrame: Day 7
measure: Number of Subjects With the Presence of Headache.
timeFrame: Day 10
measure: Number of Subjects With the Presence of Headache.
timeFrame: Day 14
measure: Number of Subjects With the Presence of General Weakness.
timeFrame: Day 3
measure: Number of Subjects With the Presence of General Weakness.
timeFrame: Day 7
measure: Number of Subjects With the Presence of General Weakness.
timeFrame: Day 10
measure: Number of Subjects With the Presence of General Weakness.
timeFrame: Day 14
measure: Number of Subjects With the Presence of Pain.
timeFrame: Day 3
measure: Number of Subjects With the Presence of Pain.
timeFrame: Day 7
measure: Number of Subjects With the Presence of Pain.
timeFrame: Day 10
measure: Number of Subjects With the Presence of Pain.
timeFrame: Day 14
measure: Number of Subjects With the Presence of Irritability/Confusion.
timeFrame: Day 3
measure: Number of Subjects With the Presence of Irritability/Confusion.
timeFrame: Day 7
measure: Number of Subjects With the Presence of Irritability/Confusion.
timeFrame: Day 10
measure: Number of Subjects With the Presence of Irritability/Confusion.
timeFrame: Day 14
measure: Number of Subjects With the Presence of Diarrhea.
timeFrame: Day 3
measure: Number of Subjects With the Presence of Diarrhea.
timeFrame: Day 7
measure: Number of Subjects With the Presence of Diarrhea.
timeFrame: Day 10
measure: Number of Subjects With the Presence of Diarrhea.
timeFrame: Day 14
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Jocelyn Dupuis, MD
role: PRINCIPAL_INVESTIGATOR
References: