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Prospective Registry of Corona Virus Disease 2019 (Covid-19) Patients With Neuromuscular Involvement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04367350
Recruitment Status : Unknown
Verified April 2020 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
COVID Sars-CoV2 Corona Virus Infection Myositis Myocarditis Diagnostic Test: laboratory biomarkers Diagnostic Test: muscle ultrasound

Detailed Description:
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).
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Prospective Registry for Multimodal Assessment of Neuromuscular Pathology Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Actual Study Start Date : March 20, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: laboratory biomarkers
    creatine kinase, troponin, urine myoglobin, and autoimmune antibodies
  • Diagnostic Test: muscle ultrasound
    Muscle echogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score)

Outcome Measures
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Primary Outcome Measures :
  1. Rate of elevated creatine kinase in hyperacute phase [ Time Frame: 1 week ]
    Elevation of creatine kinase during hyperacute phase of corona virus disease 2019 (Covid-19)


Secondary Outcome Measures :
  1. Rate of elevated creatine kinase [ Time Frame: 24 months ]
    Elevation of creatine kinase during hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)

  2. Rate of two-peak elevation of creatine kinase during acute phase [ Time Frame: 30 days ]
    Two-peak elevation of creatine kinase during acute phase of corona virus disease 2019 (Covid-19)

  3. Rate of myositis-specific antibodies [ Time Frame: 24 months ]
    Presence of myositis-specific antibodies on admission, at two weeks, and at end of follow-up

  4. Rate of antimyocardial antibodies [ Time Frame: 24 months ]
    Presence of antimyocardial antibodies on admission, at two weeks, and at end of follow-up

  5. Area under the curve (AUC) of elevated creatine kinase [ Time Frame: 24 months ]
    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)

  6. Peak-levels of elevated creatine kinase [ Time Frame: 24 months ]
    Maximal value of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)

  7. Peak-levels of troponin [ Time Frame: 30 days ]
    Maximal value of troponin in the acute phase of corona virus disease 2019 (Covid-19)

  8. Peak-levels of urine myoglobin [ Time Frame: 30 days ]
    Maximal value of urine myoglobin in the acute of corona virus disease 2019 (Covid-19)

  9. Rate of muscle hyperechogenicity [ Time Frame: 24 months ]
    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)

  10. Peak-muscle hyperechogenicity [ Time Frame: 24 months ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection

Exclusion Criteria:

  • active or known history of myopathy or advanced stage neuropathy
  • refusal to participate in clinical research
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367350


Contacts
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Contact: Alexander Grimm, MD +49 (0) 7071-29 ext 0 alexander.grimm@med.uni-tuebingen.de
Contact: Sven Poli, MD +49 (0) 7071-29 ext 83269 sven.poli@uni-tuebingen.de

Locations
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Germany
University Hospital Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Alexander Grimm, MD    +49 (0) 7071-29 ext 0    alexander.grimm@med.uni-tuebingen.de   
Contact: Sven Poli, MD    +49 (0) 7071-29 ext 83269    sven.poli@uni-tuebingen.de   
Sub-Investigator: Markus Krumbholz, MD         
Sub-Investigator: Helene Häberle, MD         
Sub-Investigator: Sophia Willikens, MD         
Sponsors and Collaborators
University Hospital Tuebingen
More Information
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04367350    
Other Study ID Numbers: 246/2020BO2
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
COVID-19
Coronavirus Infections
Myositis
Myocarditis
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases