Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT04715932
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2021-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000086582', 'term': 'Anosmia'}, {'id': 'D005334', 'term': 'Fever'}, {'id': 'D003371', 'term': 'Cough'}, {'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D018908', 'term': 'Muscle Weakness'}, {'id': 'D063806', 'term': 'Myalgia'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D003221', 'term': 'Confusion'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000857', 'term': 'Olfaction Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006569', 'term': 'Hesperidin'}], 'ancestors': [{'id': 'D044950', 'term': 'Flavanones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jocelyn.dupuis@icm-mhi.org', 'phone': '514 376-3330', 'title': 'Dr Jocelyn Dupuis (Principal Investigator)', 'phoneExt': '3477', 'organization': 'Montreal Heart Institute'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Only one dosage regimen of hesperidin was tested in this trial.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).', 'description': 'Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category.\n\nResults 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.', 'eventGroups': [{'id': 'EG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 20, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 109, 'otherNumAffected': 16, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Increased bronchial secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With COVID-19 Symptoms at Day 3.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'Subject has at least one of the selected COVID-19 symptoms.', 'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}, {'title': 'Subject has none of the selected COVID-19 symptoms.', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3849', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '0.60', 'ciUpperLimit': '3.69', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3', 'description': 'Number of subjects with any of the following COVID-19 symptoms: fever (temperature \\> 38 degrees), cough, shortness of breath or anosmia, at day 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With COVID-19 Symptoms at Day 7.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'Subject has at least one of the selected COVID-19 symptoms.', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}, {'title': 'Subject has none of the selected COVID-19 symptoms.', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3139', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '0.71', 'ciUpperLimit': '2.88', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Number of subjects with any of the following COVID-19 symptoms: fever (temperature \\> 38 degrees), cough, shortness of breath or anosmia, at day 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With COVID-19 Symptoms at Day 10.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'Subject has at least one of the selected COVID-19 symptoms.', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'title': 'Subject has none of the selected COVID-19 symptoms.', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5886', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.65', 'ciUpperLimit': '2.14', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 10', 'description': 'Number of subjects with any of the following COVID-19 symptoms: fever (temperature \\> 38 degrees), cough, shortness of breath or anosmia, at day 10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With COVID-19 Symptoms at Day 14.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'Subject has at least one of the selected COVID-19 symptoms.', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'Subject has none of the selected COVID-19 symptoms.', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2328', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.27', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Number of subjects with any of the following COVID-19 symptoms: fever (temperature \\> 38 degrees), cough, shortness of breath or anosmia, at day 14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Mean Number of COVID-19 Symptoms at Day 3.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.74', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '2.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1560', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.37', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated poisson regression).'}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': 'Mean number of COVID-19 symptoms (range 0-13) at day 3.', 'unitOfMeasure': 'Symptoms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Mean Number of COVID-19 Symptoms at Day 7.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.13', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '2.96', 'spread': '2.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6233', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.33', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated poisson regression)'}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'Mean number of COVID-19 symptoms (range 0-13) at day 7.', 'unitOfMeasure': 'Symptoms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Mean Number of COVID-19 Symptoms at Day 10.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.01', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8290', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.37', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated poisson regression)'}], 'paramType': 'MEAN', 'timeFrame': 'Day 10', 'description': 'Mean number of COVID-19 symptoms (range 0-13) at day 10.', 'unitOfMeasure': 'Symptoms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Mean Number of COVID-19 Symptoms at Day 14.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '1.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9222', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.40', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated poisson regression)'}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'Mean number of COVID-19 symptoms (range 0-13) at day 14.', 'unitOfMeasure': 'Symptoms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Complete Disappearance of Any Symptom.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'Complete disappearance of COVID-19 symptoms after randomization', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'No complete disappearance of COVID-19 symptoms after randomization', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8834', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to occurence of first event, assessed up to 14 days', 'description': 'The descriptive statistics are the number of participants having complete disappearance of any symptom.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Cough Symptom.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With Cough Symptom', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}, {'title': 'Without Cough Symptom', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9416', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.77', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the cough symptom at day 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Cough Symptom.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With Cough Symptom', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Without Cough Symptom', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6296', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.55', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the cough symptom at day 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Cough Symptom.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With Cough Symptom', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'Without Cough Symptom', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3711', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.40', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the cough symptom at day 10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Cough Symptom.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With Cough Symptom', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Without Cough Symptom', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5696', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.61', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the cough symptom at day 14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Fever.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of fever', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Without the presence of fever', 'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7583', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.26', 'ciUpperLimit': '2.67', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of fever (temperature \\> 38 degrees) at day 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Fever.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of fever', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Without the presence of fever', 'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.20', 'ciUpperLimit': '3.58', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of fever (temperature \\> 38 degrees) at day 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Fever.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the Presence of Fever', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Without the Presence of Fever', 'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5591', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '0.30', 'ciUpperLimit': '9.42', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of fever (temperature \\> 38 degrees) at day 10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Fever.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of fever', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Without the presence of fever', 'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9983', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of fever (temperature \\> 38 degrees) at day 14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Shortness of Breath.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of shortness of breath', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'Without the presence of shortness of breath', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.60', 'ciLowerLimit': '0.90', 'ciUpperLimit': '2.82', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of shortness of breath at day 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Shortness of Breath.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of shortness of breath', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'Without the presence of shortness of breath', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8382', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.98', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of shortness of breath at day 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Shortness of Breath.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of shortness of breath', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Without the presence of shortness of breath', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5912', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.59', 'ciUpperLimit': '2.51', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of shortness of breath at day 10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Shortness of Breath.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of shortness of breath', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Without the presence of shortness of breath', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of shortness of breath at day 14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Anosmia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of anosmia', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}, {'title': 'Without the presence of anosmia', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3686', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.45', 'ciUpperLimit': '1.35', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of anosmia at day 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Anosmia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of anosmia', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Without the presence of anosmia', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8711', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.86', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of anosmia at day 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Anosmia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of anosmia', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Without the presence of anosmia', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.87', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of anosmia at day 10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Anosmia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of anosmia', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Without the presence of anosmia', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2952', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.37', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of anosmia at day 14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Feverish or Chills.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of feverish or chills', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Without the presence of feverish or chills', 'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5894', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.62', 'ciUpperLimit': '2.34', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of feverish or chills at day 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Feverish or Chills.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of feverish or chills', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Without the presence of feverish or chills', 'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7887', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.45', 'ciUpperLimit': '2.89', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of feverish or chills at day 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Feverish or Chills.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of feverish or chills', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Without the presence of feverish or chills', 'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6348', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.20', 'ciUpperLimit': '2.70', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of feverish or chills at day 10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Feverish or Chills.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules 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'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Sore Throat.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of sore throat', 'measurements': [{'value': '33', 'groupId': 'OG000'}, 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occurred or not.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Sore Throat.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of sore throat', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Without the presence of sore throat', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2613', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.57', 'ciLowerLimit': '0.71', 'ciUpperLimit': '3.47', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of sore throat at day 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Sore Throat.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of sore throat', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Without the presence of sore throat', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7273', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.27', 'ciUpperLimit': '2.49', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of sore throat at day 10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Sore Throat.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of sore throat', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Without the presence of sore throat', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8909', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.19', 'ciUpperLimit': '4.19', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of sore throat at day 14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Runny Nose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of runny nose', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Without the presence of runny nose', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1438', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.87', 'ciUpperLimit': '2.67', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of runny nose at day 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Runny Nose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of runny nose', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'Without the presence of runny nose', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3440', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.71', 'ciUpperLimit': '2.68', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of runny nose at day 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Runny Nose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of runny nose', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Without the presence of runny nose', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5968', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.58', 'ciUpperLimit': '2.56', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of runny nose at day 10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Runny Nose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of runny nose', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Without the presence of runny nose', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3620', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.62', 'ciUpperLimit': '3.76', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of runny nose at day 14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Nausea/Vomiting.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of nausea/vomiting', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Without the presence of nausea/vomiting', 'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0875', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '0.91', 'ciUpperLimit': '4.27', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed model (repeated binary logistic regression)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of nausea/vomiting at day 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 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{'type': 'SECONDARY', 'title': 'Number of Subjects With the Presence of Diarrhea.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}, {'id': 'OG001', 'title': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.'}], 'classes': [{'categories': [{'title': 'With the presence of diarrhea', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Without the presence of diarrhea', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1748', 'groupIds': ['OG000', 'OG001'], 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[{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other 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'unitOfMeasure': 'Participants'}, {'title': 'Chronic Obstructive Pulmonary Disease (COPD)', 'classes': [{'categories': [{'title': 'With COPD', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Without COPD', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pulmonary Fibrosis', 'classes': [{'categories': [{'title': 'With Pulmonary Fibrosis', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Without Pulmonary Fibrosis', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Other Respiratory Disease', 'classes': [{'categories': [{'title': 'With Other Respiratory Disease', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Without Other Respiratory Disease', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-17', 'size': 881466, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-03T11:21', 'hasProtocol': True}, {'date': '2021-04-29', 'size': 1055717, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-03T11:21', 'hasProtocol': False}, {'date': '2021-01-21', 'size': 464338, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-12-14T15:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2021-01-15', 'resultsFirstSubmitDate': '2022-02-22', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-06', 'studyFirstPostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With COVID-19 Symptoms at Day 3.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with any of the following COVID-19 symptoms: fever (temperature \\> 38 degrees), cough, shortness of breath or anosmia, at day 3.'}, {'measure': 'Number of Subjects With COVID-19 Symptoms at Day 7.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with any of the following COVID-19 symptoms: fever (temperature \\> 38 degrees), cough, shortness of breath or anosmia, at day 7.'}, {'measure': 'Number of Subjects With COVID-19 Symptoms at Day 10.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with any of the following COVID-19 symptoms: fever (temperature \\> 38 degrees), cough, shortness of breath or anosmia, at day 10.'}, {'measure': 'Number of Subjects With COVID-19 Symptoms at Day 14.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with any of the following COVID-19 symptoms: fever (temperature \\> 38 degrees), cough, shortness of breath or anosmia, at day 14.'}], 'secondaryOutcomes': [{'measure': 'Mean Number of COVID-19 Symptoms at Day 3.', 'timeFrame': 'Day 3', 'description': 'Mean number of COVID-19 symptoms (range 0-13) at day 3.'}, {'measure': 'Mean Number of COVID-19 Symptoms at Day 7.', 'timeFrame': 'Day 7', 'description': 'Mean number of COVID-19 symptoms (range 0-13) at day 7.'}, {'measure': 'Mean Number of COVID-19 Symptoms at Day 10.', 'timeFrame': 'Day 10', 'description': 'Mean number of COVID-19 symptoms (range 0-13) at day 10.'}, {'measure': 'Mean Number of COVID-19 Symptoms at Day 14.', 'timeFrame': 'Day 14', 'description': 'Mean number of COVID-19 symptoms (range 0-13) at day 14.'}, {'measure': 'Number of Subjects With Complete Disappearance of Any Symptom.', 'timeFrame': 'From randomization to occurence of first event, assessed up to 14 days', 'description': 'The descriptive statistics are the number of participants having complete disappearance of any symptom.'}, {'measure': 'Number of Subjects With the Cough Symptom.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the cough symptom at day 3.'}, {'measure': 'Number of Subjects With the Cough Symptom.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the cough symptom at day 7.'}, {'measure': 'Number of Subjects With the Cough Symptom.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the cough symptom at day 10.'}, {'measure': 'Number of Subjects With the Cough Symptom.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the cough symptom at day 14.'}, {'measure': 'Number of Subjects With the Presence of Fever.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of fever (temperature \\> 38 degrees) at day 3.'}, {'measure': 'Number of Subjects With the Presence of Fever.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of fever (temperature \\> 38 degrees) at day 7.'}, {'measure': 'Number of Subjects With the Presence of Fever.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of fever (temperature \\> 38 degrees) at day 10.'}, {'measure': 'Number of Subjects With the Presence of Fever.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of fever (temperature \\> 38 degrees) at day 14.'}, {'measure': 'Number of Subjects With the Presence of Shortness of Breath.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of shortness of breath at day 3.'}, {'measure': 'Number of Subjects With the Presence of Shortness of Breath.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of shortness of breath at day 7.'}, {'measure': 'Number of Subjects With the Presence of Shortness of Breath.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of shortness of breath at day 10.'}, {'measure': 'Number of Subjects With the Presence of Shortness of Breath.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of shortness of breath at day 14.'}, {'measure': 'Number of Subjects With the Presence of Anosmia.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of anosmia at day 3.'}, {'measure': 'Number of Subjects With the Presence of Anosmia.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of anosmia at day 7.'}, {'measure': 'Number of Subjects With the Presence of Anosmia.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of anosmia at day 10.'}, {'measure': 'Number of Subjects With the Presence of Anosmia.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of anosmia at day 14.'}, {'measure': 'Number of Subjects With the Presence of Feverish or Chills.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of feverish or chills at day 3.'}, {'measure': 'Number of Subjects With the Presence of Feverish or Chills.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of feverish or chills at day 7.'}, {'measure': 'Number of Subjects With the Presence of Feverish or Chills.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of feverish or chills at day 10.'}, {'measure': 'Number of Subjects With the Presence of Feverish or Chills.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of feverish or chills at day 14.'}, {'measure': 'Number of Subjects With the Presence of Sore Throat.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of sore throat at day 3.'}, {'measure': 'Number of Subjects With the Presence of Sore Throat.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of sore throat at day 7.'}, {'measure': 'Number of Subjects With the Presence of Sore Throat.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of sore throat at day 10.'}, {'measure': 'Number of Subjects With the Presence of Sore Throat.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of sore throat at day 14.'}, {'measure': 'Number of Subjects With the Presence of Runny Nose.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of runny nose at day 3.'}, {'measure': 'Number of Subjects With the Presence of Runny Nose.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of runny nose at day 7.'}, {'measure': 'Number of Subjects With the Presence of Runny Nose.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of runny nose at day 10.'}, {'measure': 'Number of Subjects With the Presence of Runny Nose.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of runny nose at day 14.'}, {'measure': 'Number of Subjects With the Presence of Nausea/Vomiting.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of nausea/vomiting at day 3.'}, {'measure': 'Number of Subjects With the Presence of Nausea/Vomiting.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of nausea/vomiting at day 7.'}, {'measure': 'Number of Subjects With the Presence of Nausea/Vomiting.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of nausea/vomiting at day 10.'}, {'measure': 'Number of Subjects With the Presence of Nausea/Vomiting.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of nausea/vomiting at day 14.'}, {'measure': 'Number of Subjects With the Presence of Headache.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of headache at day 3.'}, {'measure': 'Number of Subjects With the Presence of Headache.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of headache at day 7.'}, {'measure': 'Number of Subjects With the Presence of Headache.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of headache at day 10.'}, {'measure': 'Number of Subjects With the Presence of Headache.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of headache at day 14.'}, {'measure': 'Number of Subjects With the Presence of General Weakness.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of general weakness at day 3.'}, {'measure': 'Number of Subjects With the Presence of General Weakness.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of general weakness at day 7.'}, {'measure': 'Number of Subjects With the Presence of General Weakness.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of general weakness at day 10.'}, {'measure': 'Number of Subjects With the Presence of General Weakness.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of general weakness at day 14.'}, {'measure': 'Number of Subjects With the Presence of Pain.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of pain at day 3.'}, {'measure': 'Number of Subjects With the Presence of Pain.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of pain at day 7.'}, {'measure': 'Number of Subjects With the Presence of Pain.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of pain at day 10.'}, {'measure': 'Number of Subjects With the Presence of Pain.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of pain at day 14.'}, {'measure': 'Number of Subjects With the Presence of Irritability/Confusion.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of irritability/confusion at day 3.'}, {'measure': 'Number of Subjects With the Presence of Irritability/Confusion.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of irritability/confusion at day 7.'}, {'measure': 'Number of Subjects With the Presence of Irritability/Confusion.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of irritability/confusion at day 10.'}, {'measure': 'Number of Subjects With the Presence of Irritability/Confusion.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of irritability/confusion at day 14.'}, {'measure': 'Number of Subjects With the Presence of Diarrhea.', 'timeFrame': 'Day 3', 'description': 'Number of subjects with the presence of diarrhea at day 3.'}, {'measure': 'Number of Subjects With the Presence of Diarrhea.', 'timeFrame': 'Day 7', 'description': 'Number of subjects with the presence of diarrhea at day 7.'}, {'measure': 'Number of Subjects With the Presence of Diarrhea.', 'timeFrame': 'Day 10', 'description': 'Number of subjects with the presence of diarrhea at day 10.'}, {'measure': 'Number of Subjects With the Presence of Diarrhea.', 'timeFrame': 'Day 14', 'description': 'Number of subjects with the presence of diarrhea at day 14.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Anosmia', 'Fever', 'Cough', 'Shortness of Breath', 'Sore Throat', 'Nausea', 'Vomiting', 'Headache', 'Muscle Weakness', 'Pain, Muscle', 'Pain, Chest', 'Pain, Joint', 'Pain, Abdominal', 'Pain', 'Irritable Mood', 'Confusion']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "This will be a randomized, double-blind, placebo-controlled study. The study will include subjects from Quebec diagnosed with COVID-19 infections. Following informed consent, 216 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either hesperidin 1000 mg once daily (q.d.)) or placebo (1:1 allocation ratio) for 14 days. Investigational drug will be delivered to the patients' homes with an electronic oral thermometer and a symptoms diary. Follow-up phone assessments will occur after 3, 7, 10, and 14 days following randomization for evaluation of COVID-19 symptoms. Electronic Case Report Form (eCRF) will be completed by the research personnel over the phone with the patients. The symptoms diary will be mailed back to the coordinating center at the end of the study in a pre-addressed envelope."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Covid-19 positive by polymerase chain reaction (PCR) testing;\n* Participant must be able to evaluate their symptoms and report them in the symptoms diary;\n* Patients must be able to take their oral temperature daily with an electronic thermometer provided to them with study materials;\n* Males and females, at least 18 years of age, capable and willing to provide informed consent;\n* 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;\n* Patient must have received a diagnosis of COVID-19 infection within the last 48 hours and have one or more symptoms;\n* Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization);\n* Patient must be able and willing to comply with the requirements of this study protocol.\n\nExclusion Criteria:\n\n* Patient currently hospitalized or under immediate consideration for hospitalization;\n* Patient currently in shock or with hemodynamic instability;\n* Patient undergoing chemotherapy for cancer;\n* Patient is unable to take oral temperature using an electronic thermometer;\n* Patient who received at least one dose of the COVID-19 vaccine;\n* Female patient who is pregnant or breast-feeding or is considering becoming pregnant during the study;\n* People taking anticoagulant/antiplatelet medications, those with bleeding disorders, and people two weeks before or after surgery;\n* Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study;\n* 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;\n* Known allergy to any of the medicinal and non-medicinal ingredient: hesperidin, microcrystalline cellulose, magnesium stearate.'}, 'identificationModule': {'nctId': 'NCT04715932', 'acronym': 'Hesperidin', 'briefTitle': 'Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Hesperidin Therapy on COVID-19 Symptoms: The Hesperidin Coronavirus Study (Hesperidin)', 'orgStudyIdInfo': {'id': 'MHICC-2020-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hesperidin 1000mg', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.', 'interventionNames': ['Drug: Hesperidin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 1000mg', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Hesperidin', 'type': 'DRUG', 'description': 'Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.', 'armGroupLabels': ['Hesperidin 1000mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.', 'armGroupLabels': ['Placebo 1000mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jocelyn Dupuis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montreal Heart Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montreal Heart Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ingenew Pharmaceuticals Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}