Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT04395105
Status:
TERMINATED
Last Update Posted:
2021-06-02
First Post:
2020-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexamethasone for COVID-19 Related ARDS: a Multicenter, Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'whyStopped': 'Low rate of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-28', 'studyFirstSubmitDate': '2020-05-16', 'studyFirstSubmitQcDate': '2020-05-18', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilator-free days at 28 days', 'timeFrame': '28 days after randomization', 'description': 'Days without ventilator support in the first 28 days following randomization'}, {'measure': 'Time to successful discontinuation from mechanical ventilation', 'timeFrame': '28 days after randomization', 'description': 'Time to event (successful discontinuation from mechanical ventilation)'}], 'secondaryOutcomes': [{'measure': '28-days mortality', 'timeFrame': '28 days after randomization', 'description': 'Dead rate within 28 days of randomization'}, {'measure': 'Rate of nosocomial infections', 'timeFrame': '28 days after randomization', 'description': 'Rate of ventilator associated pneumonia, blood stream infection, urinary tract infection or candidemia in the first 28 days following randomization'}, {'measure': 'SOFA variation', 'timeFrame': '10 days after randomization', 'description': 'Variation in SOFA over the first 10 days after randomization'}, {'measure': 'Use of prone position', 'timeFrame': '10 days after randomization', 'description': 'Cumulative hours spent on prone position'}, {'measure': 'Delirium', 'timeFrame': '28 days after randomization', 'description': 'Frequency of delirium at ICU discharge'}, {'measure': 'Muscle weakness', 'timeFrame': '28 days after randomization', 'description': 'mMRC score at ICU discharge'}, {'measure': '90-day mortality', 'timeFrame': '90 days after randomization', 'description': 'Death rate within 90 days of randomization'}, {'measure': 'Peak daily blood glucose', 'timeFrame': '10 days after randomization', 'description': 'Interaction between treatment and daily change in glucose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Distress Syndrome, Adult', 'Covid-19']}, 'referencesModule': {'references': [{'pmid': '32843098', 'type': 'DERIVED', 'citation': 'Maskin LP, Olarte GL, Palizas F Jr, Velo AE, Lurbet MF, Bonelli I, Baredes ND, Rodriguez PO. High dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to COVID-19: a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Aug 26;21(1):743. doi: 10.1186/s13063-020-04646-y.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7447582', 'label': 'Protocol publication'}]}, 'descriptionModule': {'briefSummary': 'There is compelling data indicating that there is an excessive inflammatory response in some patients with COVID-19 leading them to develop ARDS that can be severe with a very poor prognosis. Many of these patients require very long mechanical ventilation times to survive, which have led to the collapse of the health system in some regions of the world. The current evidence for the treatment of these severe forms is inconsistent and most scientific societies and governmental or international organizations recommend evaluating treatments with randomized clinical trials. Corticosteroids, being non-specific anti-inflammatory drugs, could shorten the duration of respiratory failure and improve the prognosis. Due to the lack of solid data available regarding this serious disease, our objective is to randomly evaluate the efficacy and safety of the use of dexamethasone, a parenteral corticosteroid approved in Argentina, in patients with ARDS with confirmed respiratory infection due to SARS-CoV-2 (COVID-19).\n\nAfter RECOVERY trial prepublication, low dose (6 mg QD for 10 days) dexamethasone was recommended as the usual care treatment for severe COVID-19. At this time only 3 patients had been included in the trial. Thus, we updated our recommendations for centers and decided to compare two different doses of this glucocorticoid for the treatment of ADRS due to COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ARDS according to Berlin's definition\n* PCR confirmed COVID-19\n* Length of mechanical ventilation less or equal to 72 hours\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding women\n* Terminal illness with very poor prognosis according to the investigator judgement\n* Therapeutic limitation\n* Known immunocompromised condition\n* Chronic use of systemic corticosteroids\n* Participation in another randomized crinical trial\n* More than 5 days of treatment of low dose dexamethasone for COVID-19\n* Abscence of informed consent\n* Active participation in other randomized clinical trial"}, 'identificationModule': {'nctId': 'NCT04395105', 'briefTitle': 'Dexamethasone for COVID-19 Related ARDS: a Multicenter, Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno'}, 'officialTitle': 'High Versus Low Dose Dexamethasone for the Treatment of COVID-19 Related ARDS: a Multicenter and Randomized Open-label Clinical Trial', 'orgStudyIdInfo': {'id': '1264'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose Dexamethasone', 'description': 'Intravenous Dexamethasone 16 mg qd from day 1 to 5 followed by 8 mg qd from day 6 to 10', 'interventionNames': ['Drug: High-Dose Dexamethasone']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care - low dose Dexamethasone', 'description': 'Intravenous Dexamethasone 6 mg qd for 10 days based on RECOVERY trial'}], 'interventions': [{'name': 'High-Dose Dexamethasone', 'type': 'DRUG', 'otherNames': ['Corticosteroid'], 'description': 'IV Dexamethasone administered once daily: 16 mg from day 1 to 5 and 8 mg from day 6 to 10', 'armGroupLabels': ['High dose Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1425', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clínica Bazterrica', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1425', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Universitario Sede Pombo - IUC CEMIC', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanatorio Sagrado Corazon', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1431', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Hospital Universitario Sede Saaveda - IUC CEMIC'}], 'overallOfficials': [{'name': 'Pablo O Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno'}, {'name': 'Luis P Maskin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pulmonary and Critical Care Coordinator', 'investigatorFullName': 'Pablo Oscar Rodriguez', 'investigatorAffiliation': 'Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno'}}}}