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

April 28, 2020 updated by: University Hospital Tuebingen

Prospective Registry for Multimodal Assessment of Neuromuscular Pathology Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • Recruiting
        • University Hospital Tuebingen
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Markus Krumbholz, MD
        • Sub-Investigator:
          • Helene Häberle, MD
        • Sub-Investigator:
          • Sophia Willikens, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 months
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)
30 days
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
24 months
Rate of antimyocardial antibodies
Time Frame: 24 months
Presence of antimyocardial antibodies on admission, at two weeks, and at end of follow-up
24 months
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)
24 months
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)
24 months
Peak-levels of troponin
Time Frame: 30 days
Maximal value of troponin in the acute phase of corona virus disease 2019 (Covid-19)
30 days
Peak-levels of urine myoglobin
Time Frame: 30 days
Maximal value of urine myoglobin in the acute of corona virus disease 2019 (Covid-19)
30 days
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)
24 months
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)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2020

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

April 28, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 246/2020BO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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