Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
Study NCT ID:
NCT04477668
Status:
COMPLETED
Last Update Posted:
2022-09-09
First Post:
2020-07-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Helmet Non-Invasive Ventilation for COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], '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': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-06', 'studyFirstSubmitDate': '2020-07-09', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day all-cause mortality', 'timeFrame': '28 days from randomization', 'description': 'all cause mortality'}], 'secondaryOutcomes': [{'measure': 'Intubation rate within 28 days', 'timeFrame': '28 days from randomization', 'description': 'endotracheal intubation'}, {'measure': 'ICU mortality', 'timeFrame': '180 days from randomization', 'description': 'ICU death'}, {'measure': 'Hospital mortality (censored at day 180)', 'timeFrame': '180 days from randomization', 'description': 'hospital death'}, {'measure': 'Hospital length of stay', 'timeFrame': '180 days from randomization', 'description': 'length of stay in the hospital'}, {'measure': 'ICU free days at day 28', 'timeFrame': '28 days from randomization', 'description': 'days not in ICU'}, {'measure': 'Invasive ventilation-free days at day 28', 'timeFrame': '28 days from randomization', 'description': 'days without ventilator support'}, {'measure': 'Renal replacement therapy-free days at day 28', 'timeFrame': '28 days from randomization', 'description': 'days without renal replacement therapy received'}, {'measure': 'Vasopressor-free days at day 28', 'timeFrame': '28 days from randomization', 'description': 'days without vasopressor support'}, {'measure': 'Safety outcome: skin pressure ulcers', 'timeFrame': '28 days from randomization', 'description': 'presence of pressure ulcers'}, {'measure': 'Safety outcome: barotrauma', 'timeFrame': '28 days from randomization', 'description': 'incidence of barotrauma'}, {'measure': 'Serious adverse events (including cardiovascular events and device complications)', 'timeFrame': '28 days from randomization', 'description': 'reporting of abovementioned adverse events'}, {'measure': '180-day all-cause mortality', 'timeFrame': '180 days from randomization', 'description': 'all cause mortality'}, {'measure': 'Follow-up study: 180-day 5-level EQ-5D version', 'timeFrame': '180 days from randomization', 'description': 'The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['helmet nonivasive ventilation'], 'conditions': ['COVID-19', 'Acute Hypoxemic Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '36820878', 'type': 'DERIVED', 'citation': 'Arabi YM, Al-Dorzi HM, Aldekhyl S, Al Qahtani S, Abdukahil SA, Al Qasim E, Al Harbi MK, Kharaba A, Albrahim T, Alshahrani MS, Al-Fares AA, Al Bshabshe A, Mady A, Al Duhailib Z, Algethamy H, Jose J, Al Mutairi M, Al Zumai O, Al Haji H, Alaqeily A, Al Wehaibi W, Al Aseri Z, Al-Omari A, Tlayjeh H, Al-Dawood A; Saudi Critical Care Trials Group. Long-term outcomes of patients with COVID-19 treated with helmet noninvasive ventilation or usual respiratory support: follow-up study of the Helmet-COVID randomized clinical trial. Intensive Care Med. 2023 Mar;49(3):302-312. doi: 10.1007/s00134-023-06981-5. Epub 2023 Feb 23.'}, {'pmid': '36125473', 'type': 'DERIVED', 'citation': 'Arabi YM, Aldekhyl S, Al Qahtani S, Al-Dorzi HM, Abdukahil SA, Al Harbi MK, Al Qasim E, Kharaba A, Albrahim T, Alshahrani MS, Al-Fares AA, Al Bshabshe A, Mady A, Al Duhailib Z, Algethamy H, Jose J, Al Mutairi M, Al Zumai O, Al Haji H, Alaqeily A, Al Aseri Z, Al-Omari A, Al-Dawood A, Tlayjeh H; Saudi Critical Care Trials Group. Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19: The HELMET-COVID Randomized Clinical Trial. JAMA. 2022 Sep 20;328(11):1063-1072. doi: 10.1001/jama.2022.15599.'}, {'pmid': '35109898', 'type': 'DERIVED', 'citation': 'Arabi Y, Aldekhyl S, Al Qahtani S, Al-Dorzi HM, Abdukahil SA, Jose J, Al Harbi MK, Al Haji H, Al Mutairi M, Al Zumai O, Al Qasim E, Al Wehaibi W, Alshahrani M, Albrahim T, Mady A, Al Bshabshe A, Al Aseri Z, Al Duhailib Z, Kharaba A, Alqahtani R, Algethamy H, Alfaris O, Alnafel O, Al-Fares AA, Tlayjeh H. Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial. Trials. 2022 Feb 2;23(1):105. doi: 10.1186/s13063-021-05988-x.'}, {'pmid': '34446500', 'type': 'DERIVED', 'citation': 'Arabi YM, Tlayjeh H, Aldekhyl S, Al-Dorzi HM, Abdukahil SA, Al Harbi MK, Al Haji H, Al Mutairi M, Al Zumai O, Al Qasim E, Al Wehaibi W, Al Qahtani S, Al-Hameed F, Chalabi J, Alshahrani M, Albrahim T, Alharthy A, Mady A, Bin Eshaq A, Al Bshabshe AA, Al Aseri Z, Al Duhailib Z, Kharaba A, Alqahtani R, Al Ghamdi A, Altalag A, Alghamdi K, Almaani M, Algethamy H, Al Aqeily A, Al Baseet F, Al Samannoudi H, Al Obaidi M, Ismaiel YT, Al-Fares AA. Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial. BMJ Open. 2021 Aug 26;11(8):e052169. doi: 10.1136/bmjopen-2021-052169.'}]}, 'descriptionModule': {'briefSummary': 'Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce 28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia and acute hypoxemic respiratory failure', 'detailedDescription': 'This will be a pragmatic parallel randomized control trial that will compare helmet nonivasive ventilation with standard of care to standard of care alone in 1:1 ratio. The trial will be implemented in multiple centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected or confirmed COVID-19\n* Aged ≥14 years old at the participating ICU. ICUs that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years)\n* Acute hypoxemic respiratory failure based on PaO2/FiO2 ratio \\<200 despite supplemental oxygen with a partial or non-rebreathing mask at a flow rate \\>10 L/min or above\n* Intact airway protective gag reflex\n* Able to follow instructions (e.g. squeeze hand on command, eye contact with care provider, stick out tongue on command, etc.)\n\nExclusion Criteria:\n\n* Prior intubation during this hospital admission\n* Cardiopulmonary arrest\n* Glasgow coma scale \\<12\n* Tracheostomy\n* Upper airway obstruction\n* Active epistaxis\n* Requirement for more than one vasopressor to maintain mean arterial pressure \\> 65 mm Hg\n* Pregnancy\n* Imminent intubation\n* Patients with do not intubate orders or equivalent\n* Enrolled in another trial for which co-enrolment is not approved including trials on mechanical ventilation\n* Patients already treated with helmet\n* Patients with chronic carbon dioxide retention (PaCO2 \\>45)\n* Previous enrolment in this trial\n* The primary cause of respiratory failure is not heart failure as judged by the treating team'}, 'identificationModule': {'nctId': 'NCT04477668', 'acronym': 'Helmet-COVID', 'briefTitle': 'Helmet Non-Invasive Ventilation for COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah International Medical Research Center'}, 'officialTitle': 'Helmet Non-Invasive Ventilation for COVID-19 Patients', 'orgStudyIdInfo': {'id': 'RC20/306/R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Helmet group', 'description': 'Patients will be allocated to helmet non-invasive ventilation', 'interventionNames': ['Device: Helmet non-invasive ventilation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients will be allocated to standard of care'}], 'interventions': [{'name': 'Helmet non-invasive ventilation', 'type': 'DEVICE', 'description': 'Patients will be allocated to helmet non-invasive ventilation', 'armGroupLabels': ['Helmet group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11426', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Yaseen Arabi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Abdulaziz Medical City - Riyadh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah International Medical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'King Abdulaziz Medical City, Riyadh, Saudi Arabia', 'class': 'UNKNOWN'}, {'name': 'King Fahd Hospital of the University, Al Khobar, Saudi Arabia', 'class': 'UNKNOWN'}, {'name': 'Aseer Central Hospital, Abha, Saudi Arabia', 'class': 'UNKNOWN'}, {'name': 'King Faisal Specialist Hospital & Research Center', 'class': 'OTHER'}, {'name': 'King Fahad Hospital, Madinah, Saudi Arabia', 'class': 'UNKNOWN'}, {'name': 'Al Amiri Hospital, Kuwait', 'class': 'UNKNOWN'}, {'name': 'King Abdulaziz University', 'class': 'OTHER'}, {'name': 'King Saud Medical City', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}