Phase 2
Completed N=216
Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)
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
| Outcome | Result | p-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.
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.