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Phase 2 Completed N=216 Randomized Quadruple-blind Treatment

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

Covid19 · Anosmia · Fever · Cough
Source: ClinicalTrials.gov NCT04715932 ↗
Enrolled (actual)
216
Serious AEs
2.3%
Results posted
Apr 2022
Primary outcomePrimary: Number of Subjects With COVID-19 Symptoms at Day 3. — 93; 90; 9; 13 Participants — p=0.3849

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With COVID-19 Symptoms at Day 3.
93; 90; 9; 13 0.3849
PRIMARY
Number of Subjects With COVID-19 Symptoms at Day 7.
74; 76; 17; 25 0.3139
PRIMARY
Number of Subjects With COVID-19 Symptoms at Day 10.
58; 60; 32; 39 0.5886
PRIMARY
Number of Subjects With COVID-19 Symptoms at Day 14.
39; 55; 40; 39 0.2328
SECONDARY
Mean Number of COVID-19 Symptoms at Day 3.
4.74; 4.16 0.1560
SECONDARY
Mean Number of COVID-19 Symptoms at Day 7.
3.13; 2.96 0.6233
SECONDARY
Mean Number of COVID-19 Symptoms at Day 10.
2.01; 1.95 0.8290
SECONDARY
Mean Number of COVID-19 Symptoms at Day 14.
1.38; 1.40 0.9222
SECONDARY
Number of Subjects With Complete Disappearance of Any Symptom.
29; 33; 77; 73 0.8834
SECONDARY
Number of Subjects With the Cough Symptom.
21; 29; 58; 66 0.5696
SECONDARY
Number of Subjects With the Cough Symptom.
21; 29; 58; 66 0.5696
SECONDARY
Number of Subjects With the Cough Symptom.
21; 29; 58; 66 0.5696
SECONDARY
Number of Subjects With the Cough Symptom.
21; 29; 58; 66 0.5696
SECONDARY
Number of Subjects With the Presence of Fever.
0; 1; 79; 93 0.9983
SECONDARY
Number of Subjects With the Presence of Fever.
0; 1; 79; 93 0.9983
SECONDARY
Number of Subjects With the Presence of Fever.
0; 1; 79; 93 0.9983
SECONDARY
Number of Subjects With the Presence of Fever.
0; 1; 79; 93 0.9983
SECONDARY
Number of Subjects With the Presence of Shortness of Breath.
14; 13; 65; 82
SECONDARY
Number of Subjects With the Presence of Shortness of Breath.
14; 13; 65; 82
SECONDARY
Number of Subjects With the Presence of Shortness of Breath.
14; 13; 65; 82
SECONDARY
Number of Subjects With the Presence of Shortness of Breath.
14; 13; 65; 82
SECONDARY
Number of Subjects With the Presence of Anosmia.
20; 31; 59; 64 0.2952
SECONDARY
Number of Subjects With the Presence of Anosmia.
20; 31; 59; 64 0.2952
SECONDARY
Number of Subjects With the Presence of Anosmia.
20; 31; 59; 64 0.2952
SECONDARY
Number of Subjects With the Presence of Anosmia.
20; 31; 59; 64 0.2952
SECONDARY
Number of Subjects With the Presence of Feverish or Chills.
1; 3; 78; 92 0.4257
SECONDARY
Number of Subjects With the Presence of Feverish or Chills.
1; 3; 78; 92 0.4257
SECONDARY
Number of Subjects With the Presence of Feverish or Chills.
1; 3; 78; 92 0.4257
SECONDARY
Number of Subjects With the Presence of Feverish or Chills.
1; 3; 78; 92 0.4257
SECONDARY
Number of Subjects With the Presence of Sore Throat.
3; 4; 76; 91 0.8909
SECONDARY
Number of Subjects With the Presence of Sore Throat.
3; 4; 76; 91 0.8909
SECONDARY
Number of Subjects With the Presence of Sore Throat.
3; 4; 76; 91 0.8909
SECONDARY
Number of Subjects With the Presence of Sore Throat.
3; 4; 76; 91 0.8909
SECONDARY
Number of Subjects With the Presence of Runny Nose.
12; 10; 67; 85 0.3620
SECONDARY
Number of Subjects With the Presence of Runny Nose.
12; 10; 67; 85 0.3620
SECONDARY
Number of Subjects With the Presence of Runny Nose.
12; 10; 67; 85 0.3620
SECONDARY
Number of Subjects With the Presence of Runny Nose.
12; 10; 67; 85 0.3620
SECONDARY
Number of Subjects With the Presence of Nausea/Vomiting.
2; 2; 77; 93 0.8528
SECONDARY
Number of Subjects With the Presence of Nausea/Vomiting.
2; 2; 77; 93 0.8528
SECONDARY
Number of Subjects With the Presence of Nausea/Vomiting.
2; 2; 77; 93 0.8528
SECONDARY
Number of Subjects With the Presence of Nausea/Vomiting.
2; 2; 77; 93 0.8528
SECONDARY
Number of Subjects With the Presence of Headache.
10; 9; 69; 86 0.5063
SECONDARY
Number of Subjects With the Presence of Headache.
10; 9; 69; 86 0.5063
SECONDARY
Number of Subjects With the Presence of Headache.
10; 9; 69; 86 0.5063
SECONDARY
Number of Subjects With the Presence of Headache.
10; 9; 69; 86 0.5063
SECONDARY
Number of Subjects With the Presence of General Weakness.
14; 17; 65; 78 0.9764
SECONDARY
Number of Subjects With the Presence of General Weakness.
14; 17; 65; 78 0.9764
SECONDARY
Number of Subjects With the Presence of General Weakness.
14; 17; 65; 78 0.9764
SECONDARY
Number of Subjects With the Presence of General Weakness.
14; 17; 65; 78 0.9764
SECONDARY
Number of Subjects With the Presence of Pain.
5; 8; 74; 87 0.6046
SECONDARY
Number of Subjects With the Presence of Pain.
5; 8; 74; 87 0.6046
SECONDARY
Number of Subjects With the Presence of Pain.
5; 8; 74; 87 0.6046
SECONDARY
Number of Subjects With the Presence of Pain.
5; 8; 74; 87 0.6046
SECONDARY
Number of Subjects With the Presence of Irritability/Confusion.
3; 1; 76; 94 0.2634
SECONDARY
Number of Subjects With the Presence of Irritability/Confusion.
3; 1; 76; 94 0.2634
SECONDARY
Number of Subjects With the Presence of Irritability/Confusion.
3; 1; 76; 94 0.2634
SECONDARY
Number of Subjects With the Presence of Irritability/Confusion.
3; 1; 76; 94 0.2634
SECONDARY
Number of Subjects With the Presence of Diarrhea.
4; 4; 75; 91 0.7906
SECONDARY
Number of Subjects With the Presence of Diarrhea.
4; 4; 75; 91 0.7906
SECONDARY
Number of Subjects With the Presence of Diarrhea.
4; 4; 75; 91 0.7906
SECONDARY
Number of Subjects With the Presence of Diarrhea.
4; 4; 75; 91 0.7906

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04715932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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