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NCT04715932: Hesperidin

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

Completed Phase 2 Results posted Last updated 8 April 2022
What this trial tests

Phase 2 trial testing Hesperidin in Covid19 in 216 participants. Completed in 7 June 2021.

Timeline
18 February 2021
Primary endpoint
25 May 2021
7 June 2021

Quick facts

Lead sponsorMontreal Heart Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment216
Start date18 February 2021
Primary completion25 May 2021
Estimated completion7 June 2021
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Montreal Heart Institute

Who can join

18 and older, any sex, with Covid19 or Anosmia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

GroupValue95% CI
Hesperidin 1000mg93
Placebo 1000mg90
Hesperidin 1000mg9
Placebo 1000mg13
Number of Subjects With COVID-19 Symptoms at Day 7. Primary · 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.

GroupValue95% CI
Hesperidin 1000mg74
Placebo 1000mg76
Hesperidin 1000mg17
Placebo 1000mg25
Number of Subjects With COVID-19 Symptoms at Day 10. Primary · 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.

GroupValue95% CI
Hesperidin 1000mg58
Placebo 1000mg60
Hesperidin 1000mg32
Placebo 1000mg39
Number of Subjects With COVID-19 Symptoms at Day 14. Primary · 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.

GroupValue95% CI
Hesperidin 1000mg39
Placebo 1000mg55
Hesperidin 1000mg40
Placebo 1000mg39
Mean Number of COVID-19 Symptoms at Day 3. Secondary · Day 3

Mean number of COVID-19 symptoms (range 0-13) at day 3.

GroupValue95% CI
Hesperidin 1000mg4.74± 2.52
Placebo 1000mg4.16± 2.39
Mean Number of COVID-19 Symptoms at Day 7. Secondary · Day 7

Mean number of COVID-19 symptoms (range 0-13) at day 7.

GroupValue95% CI
Hesperidin 1000mg3.13± 2.49
Placebo 1000mg2.96± 2.46
Mean Number of COVID-19 Symptoms at Day 10. Secondary · Day 10

Mean number of COVID-19 symptoms (range 0-13) at day 10.

GroupValue95% CI
Hesperidin 1000mg2.01± 2.19
Placebo 1000mg1.95± 2.12
Mean Number of COVID-19 Symptoms at Day 14. Secondary · Day 14

Mean number of COVID-19 symptoms (range 0-13) at day 14.

GroupValue95% CI
Hesperidin 1000mg1.38± 1.76
Placebo 1000mg1.40± 1.65
Number of Subjects With Complete Disappearance of Any Symptom. Secondary · From randomization to occurence of first event, assessed up to 14 days

The descriptive statistics are the number of participants having complete disappearance of any symptom.

GroupValue95% CI
Hesperidin 1000mg29
Placebo 1000mg33
Hesperidin 1000mg77
Placebo 1000mg73
Number of Subjects With the Cough Symptom. Secondary · Day 3

Number of subjects with the cough symptom at day 3.

GroupValue95% CI
Hesperidin 1000mg54
Placebo 1000mg54
Hesperidin 1000mg48
Placebo 1000mg49
Number of Subjects With the Cough Symptom. Secondary · Day 7

Number of subjects with the cough symptom at day 7.

GroupValue95% CI
Hesperidin 1000mg37
Placebo 1000mg45
Hesperidin 1000mg54
Placebo 1000mg57
Number of Subjects With the Cough Symptom. Secondary · Day 10

Number of subjects with the cough symptom at day 10.

GroupValue95% CI
Hesperidin 1000mg26
Placebo 1000mg35
Hesperidin 1000mg64
Placebo 1000mg65

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Hesperidin 1000mg
Serious: 4/107 (4%)
Deaths: 0/107
Placebo 1000mg
Serious: 1/108 (1%)
Deaths: 0/109

Serious adverse events (4 terms)

ReactionSystemHesperidin 1000mgPlacebo 1000mg
Arthritis bacterialInfections and infestations
PneumoniaInfections and infestations
DehydrationMetabolism and nutrition disorders
Respiratory distressRespiratory, thoracic and mediastinal disorders
Other adverse events (15 terms — click to expand)

ReactionSystemHesperidin 1000mgPlacebo 1000mg
Lower respiratory tract infectionInfections and infestations
PneumoniaInfections and infestations
SinusitisInfections and infestations
Abdominal painGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
Gastrointestinal disorderGastrointestinal disorders
RashSkin and subcutaneous tissue disorders
CheilitisGastrointestinal disorders
VomitingGastrointestinal disorders
Arthritis bacterialInfections and infestations
DehydrationMetabolism and nutrition disorders
HypoaesthesiaNervous system disorders
Loss of consciousnessNervous system disorders
Increased bronchial secretionRespiratory, thoracic and mediastinal disorders
Respiratory distressRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Arthritis bacterial, Pneumonia, Dehydration, Respiratory distress.

Data from ClinicalTrials.gov NCT04715932 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
    Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
  2. Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions.
    Alam S, Sarker MMR, Afrin S, Richi FT, et al · · 2021 · cited 61× · PMID 34122096 · DOI 10.3389/fphar.2021.671498
  3. A Review of Medicinal Plants with Antiviral Activity Available in Bangladesh and Mechanistic Insight Into Their Bioactive Metabolites on SARS-CoV-2, HIV and HBV.
    Bachar SC, Mazumder K, Bachar R, Aktar A, et al · · 2021 · cited 49× · PMID 34819855 · DOI 10.3389/fphar.2021.732891
  4. Hesperetin as an anti-SARS-CoV-2 agent can inhibit COVID-19-associated cancer progression by suppressing intracellular signaling pathways.
    Zalpoor H, Bakhtiyari M, Shapourian H, Rostampour P, et al · · 2022 · cited 30× · PMID 35994216 · DOI 10.1007/s10787-022-01054-3
  5. <i>In silico</i> investigation and potential therapeutic approaches of natural products for COVID-19: Computer-aided drug design perspective.
    Rahman MM, Islam MR, Akash S, Mim SA, et al · · 2022 · cited 18× · PMID 36072227 · DOI 10.3389/fcimb.2022.929430
  6. Review of COVID-19 Therapeutics by Mechanism: From Discovery to Approval.
    Choi HS, Choi AY, Kopp JB, Winkler CA, et al · · 2024 · cited 13× · PMID 38622939 · DOI 10.3346/jkms.2024.39.e134
  7. Post-COVID-19 Anosmia and Therapies: Stay Tuned for New Drugs to Sniff Out.
    Riccardi G, Niccolini GF, Bellizzi MG, Fiore M, et al · · 2023 · cited 11× · PMID 37366867 · DOI 10.3390/diseases11020079
  8. Fourteen-Day Evolution of COVID-19 Symptoms during the Third Wave in Nonvaccinated Subjects and Effects of Hesperidin Therapy: A Randomized, Double-Blinded, Placebo-Controlled Study.
    Dupuis J, Laurin P, Tardif JC, Hausermann L, et al · · 2022 · cited 11× · PMID 36387348 · DOI 10.1155/2022/3125662

Verify or expand the search:

Other trials of Hesperidin

Trials testing the same drug.

Other recruiting trials for Covid19

Currently open trials in the same condition.

Other Montreal Heart Institute trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04715932.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing