Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 9:56 PM
Study NCT ID:
NCT04435795
Status:
TERMINATED
Last Update Posted:
2022-06-10
First Post:
2020-06-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inhaled Ciclesonide for Outpatients With COVID19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C120481', 'term': 'ciclesonide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nicole.ezer@mcgill.ca', 'phone': '514-934-1934', 'title': 'Dr Nicole EZER', 'phoneExt': '76192', 'organization': 'Research Institute of the McGill University Health Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We were unable to recruit the intended sample size given a rapid decline in cases of covid-19 in Canada following increases in vaccination.\n\nIn addition, we did not enrich the study population for older high risk people and cannot exclude a possible benefit in earlier symptom resolution and prevention of clinical deterioration in this group.\n\nAs our trial was stopped prematurely, we might have been underpowered to show a small benefit of ciclesonide on early symptom resolution'}}, 'adverseEventsModule': {'timeFrame': '29 Days', 'eventGroups': [{'id': 'EG000', 'title': 'Ciclesonide Inhaled and Nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days\n\nCiclesonide: Ciclesonide 600mcg BID inhaled with aero chamber\n\nCiclesonide nasal: intranasal ciclesonide 200 mcg DIE', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 23, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID\n\nNormal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 15, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Voice change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'throat irritaiton', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry nose, irritated nose or nosebleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheeze', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospithalization', 'notes': 'SAE related to COVID-19, not to the study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visit to the emergency department', 'notes': 'Related to COVID-19, not to the study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide Inhaled and Nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days\n\nCiclesonide: Ciclesonide 600mcg BID inhaled with aero chamber\n\nCiclesonide nasal: intranasal ciclesonide 200 mcg DIE'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID\n\nNormal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 7', 'description': 'Proportion of participants with no symptoms of cough, fever or dyspnea at day 7', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide Inhaled and Nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days\n\nCiclesonide: Ciclesonide 600mcg BID inhaled with aero chamber\n\nCiclesonide nasal: intranasal ciclesonide 200 mcg DIE'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID\n\nNormal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide Inhaled and Nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days\n\nCiclesonide: Ciclesonide 600mcg BID inhaled with aero chamber\n\nCiclesonide nasal: intranasal ciclesonide 200 mcg DIE'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID\n\nNormal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Proportion who are reporting that they are "very much improved" or "much improved"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide Inhaled and Nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days\n\nCiclesonide: Ciclesonide 600mcg BID inhaled with aero chamber\n\nCiclesonide nasal: intranasal ciclesonide 200 mcg DIE'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID\n\nNormal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Proportion who are reporting that they are "very much improved" or "much improved"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improvement in Dyspnea: Resolution of Dyspnea at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide Inhaled and Nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days\n\nCiclesonide: Ciclesonide 600mcg BID inhaled with aero chamber\n\nCiclesonide nasal: intranasal ciclesonide 200 mcg DIE'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID\n\nNormal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 7', 'description': 'Dyspnea was defined as reporting "shortness of breath" or "chest congestion" or "chest tightness". In those who reported dyspnea at baseline, resolution will be defined as having no symptoms in these three areas.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide Inhaled and Nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days\n\nCiclesonide: Ciclesonide 600mcg BID inhaled with aero chamber\n\nCiclesonide nasal: intranasal ciclesonide 200 mcg DIE'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID\n\nNormal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 7', 'description': 'Improvement of wet or dry cough. Analysis limited to patients who reported cough at baseline. Defined as a 2 point decrease, or a decrease to 0 on a visual analogue scale that ranged from 0 for no symptoms to 10 for severe symptoms', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Hospitalized for SARS-CoV-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide Inhaled and Nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days\n\nCiclesonide: Ciclesonide 600mcg BID inhaled with aero chamber\n\nCiclesonide nasal: intranasal ciclesonide 200 mcg DIE'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID\n\nNormal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 14', 'description': 'Hospitalization for SARS-CoV-2 related illness', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide Inhaled and Nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days\n\nCiclesonide: Ciclesonide 600mcg BID inhaled with aero chamber\n\nCiclesonide nasal: intranasal ciclesonide 200 mcg DIE'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID\n\nNormal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 29', 'description': 'All cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ciclesonide Inhaled and Nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days\n\nCiclesonide: Ciclesonide 600mcg BID inhaled with aero chamber\n\nCiclesonide nasal: intranasal ciclesonide 200 mcg DIE'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID\n\nNormal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Enrolment to the trial began on 15 September 2020 in Quebec, 9 February 2021 in Ontario, and 22 March 2021 in British Columbia. The last participants were recruited on 8 June 2021.', 'preAssignmentDetails': 'Overall, 215 participants were randomised, and the modified intention-to-treat population included 203 adults with respiratory symptoms or fever.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ciclesonide Inhaled and Nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days\n\nCiclesonide: Ciclesonide 600mcg BID inhaled with aero chamber\n\nCiclesonide nasal: intranasal ciclesonide 200 mcg DIE'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID\n\nNormal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '47'}, {'value': '35', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '45'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '47'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'African canadian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Middle Eastern', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'South Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'title': 'British Columbia', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Ontario', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Quebec', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-23', 'size': 1053901, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-21T15:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'whyStopped': 'could not meet target enrolment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2020-06-16', 'resultsFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-21', 'studyFirstPostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea', 'timeFrame': 'day 7', 'description': 'Proportion of participants with no symptoms of cough, fever or dyspnea at day 7'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea', 'timeFrame': 'Day 14', 'description': 'Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14'}, {'measure': 'Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7', 'timeFrame': 'Day 7', 'description': 'Proportion who are reporting that they are "very much improved" or "much improved"'}, {'measure': 'Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14', 'timeFrame': 'Day 14', 'description': 'Proportion who are reporting that they are "very much improved" or "much improved"'}, {'measure': 'Improvement in Dyspnea: Resolution of Dyspnea at Day 7', 'timeFrame': 'day 7', 'description': 'Dyspnea was defined as reporting "shortness of breath" or "chest congestion" or "chest tightness". In those who reported dyspnea at baseline, resolution will be defined as having no symptoms in these three areas.'}, {'measure': 'Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7', 'timeFrame': 'day 7', 'description': 'Improvement of wet or dry cough. Analysis limited to patients who reported cough at baseline. Defined as a 2 point decrease, or a decrease to 0 on a visual analogue scale that ranged from 0 for no symptoms to 10 for severe symptoms'}, {'measure': 'Proportion of Participants Hospitalized for SARS-CoV-2', 'timeFrame': 'day 14', 'description': 'Hospitalization for SARS-CoV-2 related illness'}, {'measure': 'Mortality', 'timeFrame': 'day 29', 'description': 'All cause mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID 19']}, 'referencesModule': {'references': [{'pmid': '34728476', 'type': 'DERIVED', 'citation': 'Ezer N, Belga S, Daneman N, Chan A, Smith BM, Daniels SA, Moran K, Besson C, Smyth LY, Bartlett SJ, Benedetti A, Martin JG, Lee TC, McDonald EG. Inhaled and intranasal ciclesonide for the treatment of covid-19 in adult outpatients: CONTAIN phase II randomised controlled trial. BMJ. 2021 Nov 2;375:e068060. doi: 10.1136/bmj-2021-068060.'}]}, 'descriptionModule': {'briefSummary': 'The CONTAIN (CiclesOnide cliNical TriAl covId-19 treatmeNt) is a randomized control study of ciclesonide vs placebo for mild covid-19 disease. The need for potential therapy for COVID-19 patients is urgent. Ciclesonide has shown encouraging in vitro results, is easy to be used and is readily available. It has a low rate of side effects and few interactions with other drugs. It is unusual to use an inhaled steroid drug for COVID-19 but there has been new data suggesting steroids may have an antiviral effect in addition to an anti-inflammatory effect. Investigators propose to use inhaled and nasal ciclesonide to stop viral replication in the nose and airways. Investigators hope this will accelerate recovery from COVID-19 illness in individuals who are not admitted to hospital at time of diagnosis of COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSymptomatic adult patients positive by PCR for COVID-19 within 5 days of enrollment with fever, cough, or shortness of breath. Provision of Informed Consent\n\nAt day 0, patients should be at home\n\nExclusion Criteria:\n\n* Already on inhaled corticosteroid medication\n* Currently using systemic steroids (oral or intravenous or intramuscular such as Prednisone) or use of steroids 7 days prior to enrolment\n* Severely ill patients at enrollment (i.e., admitted to ICU at admission)\n* Unable to self-administer the inhaler\n* Known or suspected pregnancy and breastfeeding\n* Known allergy to study medication or its components (non-medicinal ingredients; including lactose allergy (type I))\n* Patients with untreated fungal, bacterial, or tubercular infections of the respiratory tract\n* Current hospitalization\n* Current use of oxygen at home or in the hospital'}, 'identificationModule': {'nctId': 'NCT04435795', 'acronym': 'CONTAIN', 'briefTitle': 'Inhaled Ciclesonide for Outpatients With COVID19', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Ciclesonide Clinical Trial for COVID-19 Treatment', 'orgStudyIdInfo': {'id': '2021-6696'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ciclesonide inhaled and nasal', 'description': 'Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days', 'interventionNames': ['Drug: Ciclesonide', 'Drug: Ciclesonide nasal']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID', 'interventionNames': ['Drug: Normal Saline intranasal and placebo inhaler']}], 'interventions': [{'name': 'Normal Saline intranasal and placebo inhaler', 'type': 'DRUG', 'description': 'Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID', 'armGroupLabels': ['Placebo']}, {'name': 'Ciclesonide', 'type': 'DRUG', 'otherNames': ['Alvesco'], 'description': 'Ciclesonide 600mcg BID inhaled with aero chamber', 'armGroupLabels': ['Ciclesonide inhaled and nasal']}, {'name': 'Ciclesonide nasal', 'type': 'DRUG', 'otherNames': ['Omnaris'], 'description': 'intranasal ciclesonide 200 mcg DIE', 'armGroupLabels': ['Ciclesonide inhaled and nasal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3K 2M2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Center', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Nicole Ezer, MD, FRCPC, MPH', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}