Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-02 @ 10:05 AM
Study NCT ID:
NCT04377035
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2020-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Ultrasound in COVID-19
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-23', 'studyFirstSubmitDate': '2020-05-01', 'studyFirstSubmitQcDate': '2020-05-01', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis', 'timeFrame': '2.5 months'}, {'measure': 'Incident ARDS (Adult Respiratory Distress Syndrome) and intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis', 'timeFrame': '2.5 months'}, {'measure': 'Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis', 'timeFrame': '2.5 months'}], 'secondaryOutcomes': [{'measure': 'Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis', 'timeFrame': '2.5 months'}, {'measure': 'Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis', 'timeFrame': '2.5 months'}, {'measure': 'Death from any cause after hospital admission with a confirmed COVID-19 diagnosis at follow-up', 'timeFrame': '2.5 months to 10 years'}, {'measure': 'Incident stroke after hospital admission with a confirmed COVID-19 diagnosis at follow-up', 'timeFrame': '2.5 months to 10 years'}, {'measure': 'Incident heart failure after hospital admission with a confirmed COVID-19 diagnosis at follow-up', 'timeFrame': '2.5 months to 10 years'}, {'measure': 'Incident myocardial infarction after hospital admission with a confirmed COVID-19 diagnosis at follow-up', 'timeFrame': '2.5 months to 10 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '36845050', 'type': 'DERIVED', 'citation': 'Wodschow HZ, Davidovski FS, Christensen J, Lassen MCH, Skaarup KG, Nygaard H, Moller N, Rungby J, Biering-Sorensen T, Rossing P, Jensen NJ, Laursen JC. Oral ketone esters acutely improve myocardial contractility in post-hospitalized COVID-19 patients: A randomized placebo-controlled double-blind crossover study. Front Nutr. 2023 Feb 9;10:1131192. doi: 10.3389/fnut.2023.1131192. eCollection 2023.'}, {'pmid': '36129046', 'type': 'DERIVED', 'citation': 'Olsen FJ, Lassen MCH, Skaarup KG, Christensen J, Davidovski FS, Alhakak AS, Sengelov M, Nielsen AB, Johansen ND, Graff C, Bundgaard H, Hassager C, Jabbari R, Carlsen J, Kirk O, Lindholm MG, Wiese L, Kristiansen OP, Nielsen OW, Lindegaard B, Tonder N, Ulrik CS, Lamberts M, Sivapalan P, Gislason G, Iversen K, Jensen JUS, Schou M, Svendsen JH, Aalen JM, Smiseth OA, Remme EW, Biering-Sorensen T. Myocardial Work in Patients Hospitalized With COVID-19: Relation to Biomarkers, COVID-19 Severity, and All-Cause Mortality. J Am Heart Assoc. 2022 Oct 4;11(19):e026571. doi: 10.1161/JAHA.122.026571. Epub 2022 Sep 21.'}, {'pmid': '35453059', 'type': 'DERIVED', 'citation': 'Espersen C, Platz E, Alhakak AS, Sengelov M, Simonsen JO, Johansen ND, Davidovski FS, Christensen J, Bundgaard H, Hassager C, Jabbari R, Carlsen J, Kirk O, Lindholm MG, Kristiansen OP, Nielsen OW, Jeschke KN, Ulrik CS, Sivapalan P, Iversen K, Staehr Jensen JU, Schou M, Skaarup SH, Hojbjerg Lassen MC, Skaarup KG, Biering-Sorensen T. Lung ultrasound findings following COVID-19 hospitalization: A prospective longitudinal cohort study. Respir Med. 2022 Jun;197:106826. doi: 10.1016/j.rmed.2022.106826. Epub 2022 Apr 2.'}, {'pmid': '34815326', 'type': 'DERIVED', 'citation': 'Espersen C, Platz E, Skaarup KG, Lassen MCH, Lind JN, Johansen ND, Sengelov M, Alhakak AS, Nielsen AB, Bundgaard H, Hassager C, Jabbari R, Carlsen J, Kirk O, Lindholm MG, Kristiansen OP, Nielsen OW, Jeschke KN, Ulrik CS, Sivapalan P, Gislason G, Iversen K, Jensen JUS, Schou M, Skaarup SH, Biering-Sorensen T. Lung Ultrasound Findings Associated With COVID-19 ARDS, ICU Admission, and All-Cause Mortality. Respir Care. 2022 Jan;67(1):66-75. doi: 10.4187/respcare.09108. Epub 2021 Nov 23.'}, {'pmid': '34213740', 'type': 'DERIVED', 'citation': 'Skaarup KG, Lassen MCH, Espersen C, Lind JN, Johansen ND, Sengelov M, Alhakak AS, Nielsen AB, Ravnkilde K, Hauser R, Schops LB, Holt E, Bundgaard H, Hassager C, Jabbari R, Carlsen J, Kirk O, Bodtger U, Lindholm MG, Wiese L, Kristiansen OP, Walsted ES, Nielsen OW, Lindegaard B, Tonder N, Jeschke KN, Ulrik CS, Lamberts M, Sivapalan P, Pallisgaard J, Gislason G, Iversen K, Jensen JUS, Schou M, Skaarup SH, Platz E, Biering-Sorensen T. Lung ultrasound findings in hospitalized COVID-19 patients in relation to venous thromboembolic events: the ECHOVID-19 study. J Ultrasound. 2022 Sep;25(3):457-467. doi: 10.1007/s40477-021-00605-8. Epub 2021 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'The study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater Copenhagen with a laboratory confirmed diagnosis of COVID-19. The investigators aim to examine if echocardiography - both conventional and advanced - can be used to predict which patients will develop acute respiratory distress syndrome (ARDS) or other short-term acute complications, especially focusing on cardiovascular outcomes. In addition, using a novel technique of lung ultrasound (LUS), The investigators aim to analyze specific LUS-findings, and associate them with short-term prognosis and development of ARDS and long-term cardiovascular morbidity and mortality. In all patients included, The investigators aim to examine long-term complications at timepoints: 2, 5 and 10 years of follow-up and examine if echocardiography - alone and in combination with biomarkers - can be used to detect early signs of cardiac complications and predict long-term risk of cardiovascular morbidity and mortality following COVID-19 infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In.patients from hospitals of the greater Copenhagen area', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients hospitalized at hospitals of greater Copenhagen area and Zealand with a laboratory confirmed diagnosis of COVID-19 \\> 18 years of age.\n\nExclusion Criteria:\n\n* Persons not able to cooperate\n* Persons unable to understand and sign "informed consent"'}, 'identificationModule': {'nctId': 'NCT04377035', 'briefTitle': 'The Role of Ultrasound in COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'The ECHOVID-19 Study - A Prospective Cohort Study Investigating the Acute Effect of COVID-19 on the Heart and Lung by Ultrasound', 'orgStudyIdInfo': {'id': 'H-20021500'}}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Tor Biering-Sørensen, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor and Research Director, Cardiovascular Non-Invasive Imaging Research Laboratory', 'investigatorFullName': 'Tor Biering-Sørensen', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}