Covid19Phase 2HesperidinNCT04715932

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

A Phase 2 study testing Hesperidin in people with Covid19 and Anosmia, run by Montreal Heart Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19, Anosmia, Fever
What is being tested?: Hesperidin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 216 participants
Where: 1 siteCanada
Study dates: 18 Feb 2021to 7 Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Montreal Heart Institute
Montreal, Quebec, H1T1C8

Other trials in Canada

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Hesperidin Therapy on COVID-19 Symptoms: The Hesperidin Coronavirus Study (Hesperidin)

Read the 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
Being tested: Hesperidin, Placebo
Medical subject headings: COVID-19, Anosmia, Fever, Cough, Dyspnea, Pharyngitis, Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HesperidinDrug
Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
PlaceboDrug
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.

Study groups in NCT04715932
Study group	Role	What they receive
Hesperidin 1000mg	Active comparator	Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water. Receives: Drug: Hesperidin
Placebo 1000mg	Placebo comparator	Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14

Secondary outcomes (57)

Mean Number of COVID-19 Symptoms at Day 3.
Mean number of COVID-19 symptoms (range 0-13) at day 3.
Measured: Day 3
Mean Number of COVID-19 Symptoms at Day 7.
Mean number of COVID-19 symptoms (range 0-13) at day 7.
Measured: Day 7
Mean Number of COVID-19 Symptoms at Day 10.
Mean number of COVID-19 symptoms (range 0-13) at day 10.
Measured: Day 10
Mean Number of COVID-19 Symptoms at Day 14.
Mean number of COVID-19 symptoms (range 0-13) at day 14.
Measured: 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.
Measured: 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.
Measured: Day 3
Number of Subjects With the Cough Symptom.
Number of subjects with the cough symptom at day 7.
Measured: Day 7
Number of Subjects With the Cough Symptom.
Number of subjects with the cough symptom at day 10.
Measured: Day 10
Number of Subjects With the Cough Symptom.
Number of subjects with the cough symptom at day 14.
Measured: Day 14
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature > 38 degrees) at day 3.
Measured: Day 3
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature > 38 degrees) at day 7.
Measured: Day 7
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature > 38 degrees) at day 10.
Measured: Day 10
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature > 38 degrees) at day 14.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 3.
Measured: Day 3
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 7.
Measured: Day 7
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 10.
Measured: Day 10
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 14.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 3.
Measured: Day 3
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 7.
Measured: Day 7
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 10.
Measured: Day 10
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 14.
Measured: Day 14
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 3.
Measured: Day 3
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 7.
Measured: Day 7
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 10.
Measured: Day 10
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 14.
Measured: Day 14
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 3.
Measured: Day 3
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 7.
Measured: Day 7
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 10.
Measured: Day 10
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 14.
Measured: Day 14
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 3.
Measured: Day 3
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 7.
Measured: Day 7
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 10.
Measured: Day 10
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 14.
Measured: Day 14
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 3.
Measured: Day 3
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 7.
Measured: Day 7
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 10.
Measured: Day 10
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 14.
Measured: Day 14
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 3.
Measured: Day 3
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 7.
Measured: Day 7
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 10.
Measured: Day 10
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 14.
Measured: Day 14
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 3.
Measured: Day 3
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 7.
Measured: Day 7
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 10.
Measured: Day 10
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 14.
Measured: Day 14
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 3.
Measured: Day 3
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 7.
Measured: Day 7
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 10.
Measured: Day 10
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 14.
Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 20217 Jun 2021

First posted20 Jan 2021
Study start18 Feb 2021
Primary completion25 May 2021
Study completion7 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04715932
Sponsor's protocol ID: MHICC-2020-003
Acronym: Hesperidin
Status last verified: Apr 2022
First submitted: 15 Jan 2021
Last updated: 8 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Hesperidin Therapy on COVID-19 Symptoms: The Hesperidin Coronavirus Study (Hesperidin)
ClinicalTrials.gov ID: NCT04715932
Acronym / sponsor ID: Hesperidin / MHICC-2020-003
Conditions: Covid19, Anosmia, Fever, Cough, Shortness of Breath, Sore Throat
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: Montreal Heart InstituteUniversity, hospital or other
Collaborators: Ingenew Pharmaceuticals Inc.
Study start: 18 Feb 2021 (actual)
Primary completion: 25 May 2021 (actual)
Study completion: 7 Jun 2021 (actual)
First posted: 20 Jan 2021 (actual)
Results: Posted 8 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Hesperidin 1000mg	Active comparator	Drug: HesperidinPatients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
Placebo 1000mg	Placebo comparator	Drug: PlaceboPatients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HesperidinPatients 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 1000mg
PlaceboPatients 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 1000mg

Primary outcome

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.
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.
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.
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.

57 secondary outcomes

Mean Number of COVID-19 Symptoms at Day 3.
Time frame: Day 3
Mean Number of COVID-19 Symptoms at Day 7.
Time frame: Day 7
Mean Number of COVID-19 Symptoms at Day 10.
Time frame: Day 10
Mean Number of COVID-19 Symptoms at Day 14.
Time frame: Day 14
Number of Subjects With 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.
Time frame: Day 3
Number of Subjects With the Cough Symptom.
Time frame: Day 7
Number of Subjects With the Cough Symptom.
Time frame: Day 10
Number of Subjects With the Cough Symptom.
Time frame: Day 14
Number of Subjects With the Presence of Fever.
Time frame: Day 3
Number of Subjects With the Presence of Fever.
Time frame: Day 7
Number of Subjects With the Presence of Fever.
Time frame: Day 10
Number of Subjects With the Presence of Fever.
Time frame: Day 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.
Time frame: Day 7
Number of Subjects With the Presence of Shortness of Breath.
Time frame: Day 10
Number of Subjects With the Presence of Shortness of Breath.
Time frame: Day 14
Number of Subjects With the Presence of Anosmia.
Time frame: Day 3
Number of Subjects With the Presence of Anosmia.
Time frame: Day 7
Number of Subjects With the Presence of Anosmia.
Time frame: Day 10
Number of Subjects With the Presence of Anosmia.
Time frame: Day 14
Number of Subjects With the Presence of Feverish or Chills.
Time frame: Day 3
Number of Subjects With the Presence of Feverish or Chills.
Time frame: Day 7
Number of Subjects With the Presence of Feverish or Chills.
Time frame: Day 10
Number of Subjects With the Presence of Feverish or Chills.
Time frame: Day 14
Number of Subjects With the Presence of Sore Throat.
Time frame: Day 3
Number of Subjects With the Presence of Sore Throat.
Time frame: Day 7
Number of Subjects With the Presence of Sore Throat.
Time frame: Day 10
Number of Subjects With the Presence of Sore Throat.
Time frame: Day 14
Number of Subjects With the Presence of Runny Nose.
Time frame: Day 3
Number of Subjects With the Presence of Runny Nose.
Time frame: Day 7
Number of Subjects With the Presence of Runny Nose.
Time frame: Day 10
Number of Subjects With the Presence of Runny Nose.
Time frame: Day 14
Number of Subjects With the Presence of Nausea/Vomiting.
Time frame: Day 3
Number of Subjects With the Presence of Nausea/Vomiting.
Time frame: Day 7
Number of Subjects With the Presence of Nausea/Vomiting.
Time frame: Day 10
Number of Subjects With the Presence of Nausea/Vomiting.
Time frame: Day 14
Number of Subjects With the Presence of Headache.
Time frame: Day 3
Number of Subjects With the Presence of Headache.
Time frame: Day 7
Number of Subjects With the Presence of Headache.
Time frame: Day 10

Results and safety

Results posted to the registry on 8 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hesperidin 1000mg	107	106
Placebo 1000mg	109	109

Primary outcome: Number of Subjects With COVID-19 Symptoms at Day 3.

Time frame: Day 3. Count of participants. Unit: Participants

Measure	Hesperidin 1000mg n = 102	Placebo 1000mg n = 103
Subject has at least one of the selected COVID-19 symptoms.	93	90
Subject has none of the selected COVID-19 symptoms.	9	13

Hesperidin 1000mg vs Placebo 1000mg: Odds Ratio (OR): 1.49 (95% CI 0.60 to 3.69), p = 0.3849, Mixed Models Analysis

Population analysed: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.

Primary outcome: Number of Subjects With COVID-19 Symptoms at Day 7.

Time frame: Day 7. Count of participants. Unit: Participants

Measure	Hesperidin 1000mg n = 91	Placebo 1000mg n = 101
Subject has at least one of the selected COVID-19 symptoms.	74	76
Subject has none of the selected COVID-19 symptoms.	17	25

Hesperidin 1000mg vs Placebo 1000mg: Odds Ratio (OR): 1.43 (95% CI 0.71 to 2.88), p = 0.3139, Mixed Models Analysis

Primary outcome: Number of Subjects With COVID-19 Symptoms at Day 10.

Time frame: Day 10. Count of participants. Unit: Participants

Measure	Hesperidin 1000mg n = 90	Placebo 1000mg n = 99
Subject has at least one of the selected COVID-19 symptoms.	58	60
Subject has none of the selected COVID-19 symptoms.	32	39

Hesperidin 1000mg vs Placebo 1000mg: Odds Ratio (OR): 1.18 (95% CI 0.65 to 2.14), p = 0.5886, Mixed Models Analysis

Primary outcome: Number of Subjects With COVID-19 Symptoms at Day 14.

Time frame: Day 14. Count of participants. Unit: Participants

Measure	Hesperidin 1000mg n = 79	Placebo 1000mg n = 94
Subject has at least one of the selected COVID-19 symptoms.	39	55
Subject has none of the selected COVID-19 symptoms.	40	39

Hesperidin 1000mg vs Placebo 1000mg: Odds Ratio (OR): 0.69 (95% CI 0.38 to 1.27), p = 0.2328, Mixed Models Analysis

57 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hesperidin 1000mg	4 of 107 (3.7%)	20 of 107 (18.7%)	0 of 107
Placebo 1000mg	1 of 108 (0.9%)	16 of 108 (14.8%)	0 of 109

Limitations and caveats (from the sponsor): Only one dosage regimen of hesperidin was tested in this trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jocelyn Dupuis, MD principal investigator

Montreal Heart Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hesperidin in people with Covid19 and Anosmia, run by Montreal Heart Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With COVID-19 Symptoms at Day 3. (time frame: Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04715932.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.