Trial Outcomes & Findings for Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN) (NCT NCT04715932)
NCT ID: NCT04715932
Last Updated: 2022-04-08
Results Overview
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 3.
COMPLETED
PHASE2
216 participants
Day 3
2022-04-08
Participant Flow
216 subjects were randomized into the study with 109 assigned to placebo and 107 to hesperidin.
Participant milestones
| Measure |
Hesperidin 1000mg
Patients 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
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
109
|
|
Overall Study
COMPLETED
|
106
|
109
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Hesperidin 1000mg
Patients 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
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)
Baseline characteristics by cohort
| Measure |
Hesperidin 1000mg
n=107 Participants
Patients 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
n=109 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.31 years
STANDARD_DEVIATION 13.02 • n=99 Participants
|
40.67 years
STANDARD_DEVIATION 11.26 • n=107 Participants
|
40.98 years
STANDARD_DEVIATION 12.14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
209 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
209 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
28.12 KG/m^2
STANDARD_DEVIATION 6.38 • n=99 Participants
|
28.21 KG/m^2
STANDARD_DEVIATION 6.82 • n=107 Participants
|
28.16 KG/m^2
STANDARD_DEVIATION 6.59 • n=206 Participants
|
|
Diabetes
With Diabetes
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Diabetes
Without Diabetes
|
101 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
209 Participants
n=206 Participants
|
|
Hypertension
With Hypertension
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Hypertension
Without Hypertension
|
93 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
193 Participants
n=206 Participants
|
|
Respiratory Disease
With Respiratory Disease
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Respiratory Disease
Without Respiratory Disease
|
92 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
183 Participants
n=206 Participants
|
|
Asthma
With Asthma
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Asthma
Without Asthma
|
93 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
185 Participants
n=206 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
With COPD
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
Without COPD
|
107 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
215 Participants
n=206 Participants
|
|
Pulmonary Fibrosis
With Pulmonary Fibrosis
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Pulmonary Fibrosis
Without Pulmonary Fibrosis
|
106 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
215 Participants
n=206 Participants
|
|
Other Respiratory Disease
With Other Respiratory Disease
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Other Respiratory Disease
Without Other Respiratory Disease
|
107 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
215 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With COVID-19 Symptoms at Day 3.
Subject has at least one of the selected COVID-19 symptoms.
|
93 Participants
|
90 Participants
|
|
Number of Subjects With COVID-19 Symptoms at Day 3.
Subject has none of the selected COVID-19 symptoms.
|
9 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=101 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With COVID-19 Symptoms at Day 7.
Subject has at least one of the selected COVID-19 symptoms.
|
74 Participants
|
76 Participants
|
|
Number of Subjects With COVID-19 Symptoms at Day 7.
Subject has none of the selected COVID-19 symptoms.
|
17 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=99 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With COVID-19 Symptoms at Day 10.
Subject has at least one of the selected COVID-19 symptoms.
|
58 Participants
|
60 Participants
|
|
Number of Subjects With COVID-19 Symptoms at Day 10.
Subject has none of the selected COVID-19 symptoms.
|
32 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=94 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With COVID-19 Symptoms at Day 14.
Subject has at least one of the selected COVID-19 symptoms.
|
39 Participants
|
55 Participants
|
|
Number of Subjects With COVID-19 Symptoms at Day 14.
Subject has none of the selected COVID-19 symptoms.
|
40 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Mean number of COVID-19 symptoms (range 0-13) at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=101 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Mean Number of COVID-19 Symptoms at Day 3.
|
4.74 Symptoms
Standard Deviation 2.52
|
4.16 Symptoms
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Mean number of COVID-19 symptoms (range 0-13) at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=101 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Mean Number of COVID-19 Symptoms at Day 7.
|
3.13 Symptoms
Standard Deviation 2.49
|
2.96 Symptoms
Standard Deviation 2.46
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Mean number of COVID-19 symptoms (range 0-13) at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=99 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Mean Number of COVID-19 Symptoms at Day 10.
|
2.01 Symptoms
Standard Deviation 2.19
|
1.95 Symptoms
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Mean number of COVID-19 symptoms (range 0-13) at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=94 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Mean Number of COVID-19 Symptoms at Day 14.
|
1.38 Symptoms
Standard Deviation 1.76
|
1.40 Symptoms
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: From randomization to occurence of first event, assessed up to 14 daysPopulation: 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.
The descriptive statistics are the number of participants having complete disappearance of any symptom.
Outcome measures
| Measure |
Hesperidin 1000mg
n=106 Participants
Patients 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
n=106 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With Complete Disappearance of Any Symptom.
No complete disappearance of COVID-19 symptoms after randomization
|
77 Participants
|
73 Participants
|
|
Number of Subjects With Complete Disappearance of Any Symptom.
Complete disappearance of COVID-19 symptoms after randomization
|
29 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the cough symptom at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Cough Symptom.
With Cough Symptom
|
54 Participants
|
54 Participants
|
|
Number of Subjects With the Cough Symptom.
Without Cough Symptom
|
48 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the cough symptom at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Cough Symptom.
With Cough Symptom
|
37 Participants
|
45 Participants
|
|
Number of Subjects With the Cough Symptom.
Without Cough Symptom
|
54 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the cough symptom at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Cough Symptom.
With Cough Symptom
|
26 Participants
|
35 Participants
|
|
Number of Subjects With the Cough Symptom.
Without Cough Symptom
|
64 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the cough symptom at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Cough Symptom.
With Cough Symptom
|
21 Participants
|
29 Participants
|
|
Number of Subjects With the Cough Symptom.
Without Cough Symptom
|
58 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=101 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Fever.
With the presence of fever
|
5 Participants
|
6 Participants
|
|
Number of Subjects With the Presence of Fever.
Without the presence of fever
|
96 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=101 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Fever.
With the presence of fever
|
3 Participants
|
4 Participants
|
|
Number of Subjects With the Presence of Fever.
Without the presence of fever
|
87 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=99 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Fever.
With the Presence of Fever
|
3 Participants
|
2 Participants
|
|
Number of Subjects With the Presence of Fever.
Without the Presence of Fever
|
87 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=94 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Fever.
Without the presence of fever
|
79 Participants
|
93 Participants
|
|
Number of Subjects With the Presence of Fever.
With the presence of fever
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of shortness of breath at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Shortness of Breath.
With the presence of shortness of breath
|
46 Participants
|
35 Participants
|
|
Number of Subjects With the Presence of Shortness of Breath.
Without the presence of shortness of breath
|
56 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of shortness of breath at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Shortness of Breath.
With the presence of shortness of breath
|
28 Participants
|
30 Participants
|
|
Number of Subjects With the Presence of Shortness of Breath.
Without the presence of shortness of breath
|
63 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of shortness of breath at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Shortness of Breath.
With the presence of shortness of breath
|
19 Participants
|
18 Participants
|
|
Number of Subjects With the Presence of Shortness of Breath.
Without the presence of shortness of breath
|
71 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of shortness of breath at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Shortness of Breath.
With the presence of shortness of breath
|
14 Participants
|
13 Participants
|
|
Number of Subjects With the Presence of Shortness of Breath.
Without the presence of shortness of breath
|
65 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of anosmia at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Anosmia.
With the presence of anosmia
|
52 Participants
|
59 Participants
|
|
Number of Subjects With the Presence of Anosmia.
Without the presence of anosmia
|
50 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of anosmia at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Anosmia.
With the presence of anosmia
|
43 Participants
|
47 Participants
|
|
Number of Subjects With the Presence of Anosmia.
Without the presence of anosmia
|
48 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of anosmia at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Anosmia.
With the presence of anosmia
|
34 Participants
|
37 Participants
|
|
Number of Subjects With the Presence of Anosmia.
Without the presence of anosmia
|
56 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of anosmia at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Anosmia.
With the presence of anosmia
|
20 Participants
|
31 Participants
|
|
Number of Subjects With the Presence of Anosmia.
Without the presence of anosmia
|
59 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of feverish or chills at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Feverish or Chills.
With the presence of feverish or chills
|
24 Participants
|
21 Participants
|
|
Number of Subjects With the Presence of Feverish or Chills.
Without the presence of feverish or chills
|
78 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of feverish or chills at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Feverish or Chills.
With the presence of feverish or chills
|
10 Participants
|
10 Participants
|
|
Number of Subjects With the Presence of Feverish or Chills.
Without the presence of feverish or chills
|
81 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of feverish or chills at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Feverish or Chills.
With the presence of feverish or chills
|
4 Participants
|
6 Participants
|
|
Number of Subjects With the Presence of Feverish or Chills.
Without the presence of feverish or chills
|
86 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of feverish or chills at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Feverish or Chills.
With the presence of feverish or chills
|
1 Participants
|
3 Participants
|
|
Number of Subjects With the Presence of Feverish or Chills.
Without the presence of feverish or chills
|
78 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of sore throat at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Sore Throat.
With the presence of sore throat
|
33 Participants
|
23 Participants
|
|
Number of Subjects With the Presence of Sore Throat.
Without the presence of sore throat
|
69 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of sore throat at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Sore Throat.
With the presence of sore throat
|
17 Participants
|
13 Participants
|
|
Number of Subjects With the Presence of Sore Throat.
Without the presence of sore throat
|
74 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of sore throat at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Sore Throat.
With the presence of sore throat
|
6 Participants
|
8 Participants
|
|
Number of Subjects With the Presence of Sore Throat.
Without the presence of sore throat
|
84 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of sore throat at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Sore Throat.
With the presence of sore throat
|
3 Participants
|
4 Participants
|
|
Number of Subjects With the Presence of Sore Throat.
Without the presence of sore throat
|
76 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of runny nose at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Runny Nose.
With the presence of runny nose
|
48 Participants
|
38 Participants
|
|
Number of Subjects With the Presence of Runny Nose.
Without the presence of runny nose
|
54 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of runny nose at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Runny Nose.
With the presence of runny nose
|
25 Participants
|
22 Participants
|
|
Number of Subjects With the Presence of Runny Nose.
Without the presence of runny nose
|
66 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of runny nose at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Runny Nose.
With the presence of runny nose
|
18 Participants
|
17 Participants
|
|
Number of Subjects With the Presence of Runny Nose.
Without the presence of runny nose
|
72 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of runny nose at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Runny Nose.
With the presence of runny nose
|
12 Participants
|
10 Participants
|
|
Number of Subjects With the Presence of Runny Nose.
Without the presence of runny nose
|
67 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of nausea/vomiting at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Nausea/Vomiting.
With the presence of nausea/vomiting
|
21 Participants
|
12 Participants
|
|
Number of Subjects With the Presence of Nausea/Vomiting.
Without the presence of nausea/vomiting
|
81 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of nausea/vomiting at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Nausea/Vomiting.
With the presence of nausea/vomiting
|
9 Participants
|
11 Participants
|
|
Number of Subjects With the Presence of Nausea/Vomiting.
Without the presence of nausea/vomiting
|
82 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of nausea/vomiting at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Nausea/Vomiting.
With the presence of nausea/vomiting
|
6 Participants
|
5 Participants
|
|
Number of Subjects With the Presence of Nausea/Vomiting.
Without the presence of nausea/vomiting
|
84 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of nausea/vomiting at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Nausea/Vomiting.
With the presence of nausea/vomiting
|
2 Participants
|
2 Participants
|
|
Number of Subjects With the Presence of Nausea/Vomiting.
Without the presence of nausea/vomiting
|
77 Participants
|
93 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of headache at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Headache.
With the presence of headache
|
48 Participants
|
41 Participants
|
|
Number of Subjects With the Presence of Headache.
Without the presence of headache
|
54 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of headache at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Headache.
Without the presence of headache
|
57 Participants
|
68 Participants
|
|
Number of Subjects With the Presence of Headache.
With the presence of headache
|
34 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of headache at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Headache.
With the presence of headache
|
22 Participants
|
20 Participants
|
|
Number of Subjects With the Presence of Headache.
Without the presence of headache
|
68 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of headache at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Headache.
With the presence of headache
|
10 Participants
|
9 Participants
|
|
Number of Subjects With the Presence of Headache.
Without the presence of headache
|
69 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of general weakness at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of General Weakness.
With the presence of general weakness
|
63 Participants
|
55 Participants
|
|
Number of Subjects With the Presence of General Weakness.
Without the presence of general weakness
|
39 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of general weakness at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of General Weakness.
With the presence of general weakness
|
39 Participants
|
40 Participants
|
|
Number of Subjects With the Presence of General Weakness.
Without the presence of general weakness
|
52 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of general weakness at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of General Weakness.
With the presence of general weakness
|
20 Participants
|
21 Participants
|
|
Number of Subjects With the Presence of General Weakness.
Without the presence of general weakness
|
70 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of general weakness at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of General Weakness.
With the presence of general weakness
|
14 Participants
|
17 Participants
|
|
Number of Subjects With the Presence of General Weakness.
Without the presence of general weakness
|
65 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of pain at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Pain.
With the presence of pain
|
44 Participants
|
50 Participants
|
|
Number of Subjects With the Presence of Pain.
Without the presence of pain
|
58 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of pain at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Pain.
With the presence of pain
|
17 Participants
|
23 Participants
|
|
Number of Subjects With the Presence of Pain.
Without the presence of pain
|
74 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of pain at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Pain.
With the presence of pain
|
13 Participants
|
14 Participants
|
|
Number of Subjects With the Presence of Pain.
Without the presence of pain
|
77 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of pain at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Pain.
With the presence of pain
|
5 Participants
|
8 Participants
|
|
Number of Subjects With the Presence of Pain.
Without the presence of pain
|
74 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of irritability/confusion at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Irritability/Confusion.
With the presence of irritability/confusion
|
20 Participants
|
18 Participants
|
|
Number of Subjects With the Presence of Irritability/Confusion.
Without the presence of irritability/confusion
|
82 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of irritability/confusion at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Irritability/Confusion.
With the presence of irritability/confusion
|
6 Participants
|
10 Participants
|
|
Number of Subjects With the Presence of Irritability/Confusion.
Without the presence of irritability/confusion
|
85 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of irritability/confusion at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Irritability/Confusion.
With the presence of irritability/confusion
|
4 Participants
|
4 Participants
|
|
Number of Subjects With the Presence of Irritability/Confusion.
Without the presence of irritability/confusion
|
86 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of irritability/confusion at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Irritability/Confusion.
With the presence of irritability/confusion
|
3 Participants
|
1 Participants
|
|
Number of Subjects With the Presence of Irritability/Confusion.
Without the presence of irritability/confusion
|
76 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Number of subjects with the presence of diarrhea at day 3.
Outcome measures
| Measure |
Hesperidin 1000mg
n=102 Participants
Patients 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
n=103 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Diarrhea.
With the presence of diarrhea
|
22 Participants
|
16 Participants
|
|
Number of Subjects With the Presence of Diarrhea.
Without the presence of diarrhea
|
80 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
Number of subjects with the presence of diarrhea at day 7.
Outcome measures
| Measure |
Hesperidin 1000mg
n=91 Participants
Patients 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
n=102 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Diarrhea.
With the presence of diarrhea
|
15 Participants
|
10 Participants
|
|
Number of Subjects With the Presence of Diarrhea.
Without the presence of diarrhea
|
76 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Number of subjects with the presence of diarrhea at day 10.
Outcome measures
| Measure |
Hesperidin 1000mg
n=90 Participants
Patients 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
n=100 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Diarrhea.
With the presence of diarrhea
|
6 Participants
|
6 Participants
|
|
Number of Subjects With the Presence of Diarrhea.
Without the presence of diarrhea
|
84 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
Number of subjects with the presence of diarrhea at day 14.
Outcome measures
| Measure |
Hesperidin 1000mg
n=79 Participants
Patients 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
n=95 Participants
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Number of Subjects With the Presence of Diarrhea.
With the presence of diarrhea
|
4 Participants
|
4 Participants
|
|
Number of Subjects With the Presence of Diarrhea.
Without the presence of diarrhea
|
75 Participants
|
91 Participants
|
Adverse Events
Hesperidin 1000mg
Placebo 1000mg
Serious adverse events
| Measure |
Hesperidin 1000mg
n=107 participants at risk
Patients 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
n=108 participants at risk
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Infections and infestations
Arthritis bacterial
|
2.8%
3/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.93%
1/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.93%
1/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
1/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.00%
0/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.93%
1/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.00%
0/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
Other adverse events
| Measure |
Hesperidin 1000mg
n=107 participants at risk
Patients 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
n=108 participants at risk
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
2/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.00%
0/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Gastrointestinal disorders
Cheilitis
|
0.93%
1/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.00%
0/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
1.9%
2/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.9%
2/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.00%
0/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
1/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.00%
0/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Infections and infestations
Arthritis bacterial
|
0.93%
1/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.00%
0/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.6%
6/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
3.7%
4/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Infections and infestations
Pneumonia
|
3.7%
4/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
2.8%
3/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Infections and infestations
Sinusitis
|
0.93%
1/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
3.7%
4/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
1/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.00%
0/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.93%
1/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.00%
0/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.93%
1/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.93%
1/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.00%
0/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.93%
1/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
0.00%
0/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.93%
1/107 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
1.9%
2/108 • Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
|
Additional Information
Dr Jocelyn Dupuis (Principal Investigator)
Montreal Heart Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place