Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 9:33 AM
Study NCT ID:
NCT04366856
Status:
COMPLETED
Last Update Posted:
2021-12-13
First Post:
2020-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROne Positioning in coVID-19 Oxygeno-dependent Patients in Spontaneous Ventilation (PROVID Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 446}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-10', 'studyFirstSubmitDate': '2020-04-26', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who meet one or both following criteria: need for intubation (for mechanical ventilation), occurrence of death during hospital stay.', 'timeFrame': 'At day28'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients admitted to ICU (for patients included out of ICU)', 'timeFrame': 'At day28'}, {'measure': 'Days alive and free from non invasive ventilation (NIV) or high flow nasal canula oxygen delivery (HFNC) (for those neither under NIV or HFNC at the time of study inclusion)', 'timeFrame': 'At day28'}, {'measure': 'Days alive and out of ICU', 'timeFrame': 'At day28'}, {'measure': 'Days alive and out of hospital', 'timeFrame': 'At day28'}, {'measure': 'Maximum oxygenotherapy rate during hospital stay [Time Frame: At day28]', 'timeFrame': 'At day28'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS', 'SARS-Cov-2 infection', 'Prone position', 'Oxygenotherapy', 'Intubation'], 'conditions': ['COVID', 'ARDS']}, 'referencesModule': {'references': [{'pmid': '41370078', 'type': 'DERIVED', 'citation': 'Harrois A, Jouffroy R, Ayed S, Bruel C, Savale L, Devaux M, Maillet M, Cerf C, Lejealle C, Moreno CG, Levrat A, Gueneau R, Jouveshomme S, Bonnin P, De Rudnicki S, Damoisel C, Gille T, Cordel H, Meslin S, Bocquillon V, Noel N, Vieillard-Baron A, Teboul JL, Tran M, Werner M, Pichon J, Janbain A, Vicaut E, Duranteau J; PROVID Study Group. Awake Prone Positioning in Patients With COVID-19 Respiratory Failure: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548201. doi: 10.1001/jamanetworkopen.2025.48201.'}]}, 'descriptionModule': {'briefSummary': 'The COVID epidemics is responsible for a huge number of death following COVID acute respiratory failure. First instance treatment includes oxygenotherapy up to 15L/min in spontaneous ventilation. However COVID infection can ultimately lead to an acute respiratory distress syndrome (ARDS) requiring mechanical ventilation in the intensive care unit (ICU). Guidelines on ARDS management are based on small ventilation volume (6 mL/kg), a pulmonary end expiratory pressure (PEEP) chosen to get the best pulmonary compliance, a plateau pressure lower than 30 cm of water and daily prone positioning when PaO2/FiO2 ratio is lower than 150. In ventilated ARDS patients, prone positioning has shown survival improvement. Though they applied this optimized management of ARDS patients, Chinese intensivists have recently reported mortality rate higher than 50% in ARDS COVID patients requiring intubation and mechanical ventilation. Before being intubated and admitted to ICU, COVID patients require increasing rate of oxygen delivery. From the start of the epidemics, we have observed that an oxygenotherapy rate higher than 3L/min at the initial phase of the disease was associated with a high risk of severe acute respiratory distress (30%)\n\nThe investigators hypothesize that prone positioning in patients in spontaneous ventilation (not tubed) from the stage of oxygenotherapy higher than 3L/min (to get an SpO2 of 95% or higher) would prevent respiratory worsening and the need for intubation. Prone positioning is easy to apply in patients in spontaneous ventilation since they can change position by themselves.', 'detailedDescription': "Patients admitted to the hospital with laboratory-confirmed SARS-CoV-2 infection as determined by PCR and/or CT scan showing typical radiological findings (ground glass abnormalities) and requiring O2 3L/min to get an SpO2 higher or equal to 95%.\n\nPatients will be randomised for their position : a group with prone positioning at least 6 hours a day during hosital stay until oxygen weaning or intubation (interventional group) and a group with no instruction regarding positioning (control group). In the interventional group, patients will be suggested to spend 6 hours or more in prone position and will report themselves the time spent in prone position each day. In the control group, patients won't be given any instruction regarding positioning.\n\nPatients will be clinically assessed as usual : monitoring 4 to 8 times a day in the ward and continuous monitoring in ICU.\n\nThe need for admission to ICU, high flow nasal oxygenation, non invasive ventilation or intubation or the occurrence of death will be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the hospital\n* Laboratory-confirmed SARS-CoV-2 infection as determined by PCR and/or CT scan showing typical radiological findings (ground glass abnormalities)\n* Need for O2 3L/min to get an SpO2 higher or equal to 95%.\n* Patient able to understand and to get in prone postion themself\n* No therapeutic limitation\n\nExclusion Criteria:\n\n* Age \\> 80 years\n* Pregnancy\n* Impossibility to get in prone position'}, 'identificationModule': {'nctId': 'NCT04366856', 'acronym': 'PROVID', 'briefTitle': 'PROne Positioning in coVID-19 Oxygeno-dependent Patients in Spontaneous Ventilation (PROVID Study)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'PROne Positioning in coVID-19 Oxygeno-dependent Patients in Spontaneous Ventilation (PROVID Study)', 'orgStudyIdInfo': {'id': 'APHP200504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: Prone positioning', 'description': 'the interventional group will be suggested to spend at least 6 hours a day in prone position', 'interventionNames': ['Behavioral: 1: Prone positioning']}, {'type': 'OTHER', 'label': '2: No instruction regarding positioning', 'description': 'the control group will get no instruction regarding positioning', 'interventionNames': ['Behavioral: 2: No instruction regarding positioning']}], 'interventions': [{'name': '1: Prone positioning', 'type': 'BEHAVIORAL', 'description': 'the interventional group will be suggested to spend at least 6 hours a day in prone position', 'armGroupLabels': ['1: Prone positioning']}, {'name': '2: No instruction regarding positioning', 'type': 'BEHAVIORAL', 'description': 'group with no instruction regarding positioning (control group)', 'armGroupLabels': ['2: No instruction regarding positioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': "Département d'Anesthésie Réanimation - Kremlin Bicêtre", 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}], 'overallOfficials': [{'name': 'Anatole HARROIS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}