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

NCT ID: NCT04367350

Last Updated: 2020-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-20

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID Sars-CoV2 Corona Virus Infection Myositis Myocarditis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

laboratory biomarkers

creatine kinase, troponin, urine myoglobin, and autoimmune antibodies

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Tuebingen

Tübingen, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alexander Grimm, MD

Role: CONTACT

+49 (0) 7071-29 ext. 0

Sven Poli, MD

Role: CONTACT

+49 (0) 7071-29 ext. 83269

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alexander Grimm, MD

Role: primary

+49 (0) 7071-29 ext. 0

Sven Poli, MD

Role: backup

+49 (0) 7071-29 ext. 83269

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

246/2020BO2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Covid-19 Virtual Recovery Study
NCT04950725 COMPLETED NA
Diaphragm Training Ultrasound
NCT04186325 RECRUITING NA