Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
Study NCT ID:
NCT04367350
Status:
UNKNOWN
Last Update Posted:
2020-04-29
First Post:
2020-04-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Registry of Corona Virus Disease 2019 (Covid-19) Patients With Neuromuscular Involvement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009205', 'term': 'Myocarditis'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-28', 'studyFirstSubmitDate': '2020-04-28', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of elevated creatine kinase in hyperacute phase', 'timeFrame': '1 week', 'description': 'Elevation of creatine kinase during hyperacute phase of corona virus disease 2019 (Covid-19)'}], 'secondaryOutcomes': [{'measure': 'Rate of elevated creatine kinase', 'timeFrame': '24 months', 'description': 'Elevation of creatine kinase during hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)'}, {'measure': 'Rate of two-peak elevation of creatine kinase during acute phase', 'timeFrame': '30 days', 'description': 'Two-peak elevation of creatine kinase during acute phase of corona virus disease 2019 (Covid-19)'}, {'measure': 'Rate of myositis-specific antibodies', 'timeFrame': '24 months', 'description': 'Presence of myositis-specific antibodies on admission, at two weeks, and at end of follow-up'}, {'measure': 'Rate of antimyocardial antibodies', 'timeFrame': '24 months', 'description': 'Presence of antimyocardial antibodies on admission, at two weeks, and at end of follow-up'}, {'measure': 'Area under the curve (AUC) of elevated creatine kinase', 'timeFrame': '24 months', 'description': 'Level of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19) assessed by the area under the curve (AUC)'}, {'measure': 'Peak-levels of elevated creatine kinase', 'timeFrame': '24 months', 'description': 'Maximal value of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)'}, {'measure': 'Peak-levels of troponin', 'timeFrame': '30 days', 'description': 'Maximal value of troponin in the acute phase of corona virus disease 2019 (Covid-19)'}, {'measure': 'Peak-levels of urine myoglobin', 'timeFrame': '30 days', 'description': 'Maximal value of urine myoglobin in the acute of corona virus disease 2019 (Covid-19)'}, {'measure': 'Rate of muscle hyperechogenicity', 'timeFrame': '24 months', 'description': 'Muscle hyperechogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score) during the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)'}, {'measure': 'Peak-muscle hyperechogenicity', 'timeFrame': '24 months', 'description': 'Peak-muscle hyperechogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score) during the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID', 'Sars-CoV2', 'Corona Virus Infection', 'Myositis', 'Myocarditis']}, 'descriptionModule': {'briefSummary': 'Prospective registry for multimodal assessment of neuromuscular pathology associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, enrolling consecutive patients with corona virus disease 2019 (Covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at Tübingen University Hospital.', 'detailedDescription': 'The prospective registry shall provide new insights into muscular involvement associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. For that reason consecutive patients with proven corona virus disease 2019 (Covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at Tübingen University Hospital, are enrolled. Multimodal assessment of neuromuscular pathology is based on medical history, laboratory biomarkers including inflammation parameters and autoimmune antibodies, vital parameters monitoring, muscle ultrasound, transthoracic echocardiography, electroneurography, as well as electromyography. Inclusion of follow-up visits permit longitudinal and prognostic evaluation of diagnostic and therapeutic interventions (e.g. immunomodulation with immunoglobulins, corticosteroids, or interleukin 6 receptor antagonists).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with corona virus disease 2019 (Covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at Tübingen University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection\n\nExclusion Criteria:\n\n* active or known history of myopathy or advanced stage neuropathy\n* refusal to participate in clinical research'}, 'identificationModule': {'nctId': 'NCT04367350', 'briefTitle': 'Prospective Registry of Corona Virus Disease 2019 (Covid-19) Patients With Neuromuscular Involvement', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Prospective Registry for Multimodal Assessment of Neuromuscular Pathology Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection', 'orgStudyIdInfo': {'id': '246/2020BO2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'laboratory biomarkers', 'type': 'DIAGNOSTIC_TEST', 'description': 'creatine kinase, troponin, urine myoglobin, and autoimmune antibodies'}, {'name': 'muscle ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Muscle echogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Grimm, MD', 'role': 'CONTACT', 'email': 'alexander.grimm@med.uni-tuebingen.de', 'phone': '+49 (0) 7071-29', 'phoneExt': '0'}, {'name': 'Sven Poli, MD', 'role': 'CONTACT', 'email': 'sven.poli@uni-tuebingen.de', 'phone': '+49 (0) 7071-29', 'phoneExt': '83269'}, {'name': 'Markus Krumbholz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Helene Häberle, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sophia Willikens, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Alexander Grimm, MD', 'role': 'CONTACT', 'email': 'alexander.grimm@med.uni-tuebingen.de', 'phone': '+49 (0) 7071-29', 'phoneExt': '0'}, {'name': 'Sven Poli, MD', 'role': 'CONTACT', 'email': 'sven.poli@uni-tuebingen.de', 'phone': '+49 (0) 7071-29', 'phoneExt': '83269'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}