Clinical trial NCT04367350: Prospective Registry of Corona Virus Disease 2019 (Covid-19) Patients With Neuromuscular Involvement
Official title: Prospective Registry for Multimodal Assessment of Neuromuscular Pathology Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Sars-CoV2
Corona Virus Infection
Myositis
Myocarditis
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility 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

Primary outcomes:
measure: Rate of elevated creatine kinase in hyperacute phase
timeFrame: 1 week
Secondary outcomes:
measure: Rate of elevated creatine kinase
timeFrame: 24 months
measure: Rate of two-peak elevation of creatine kinase during acute phase
timeFrame: 30 days
measure: Rate of myositis-specific antibodies
timeFrame: 24 months
measure: Rate of antimyocardial antibodies
timeFrame: 24 months
measure: Area under the curve (AUC) of elevated creatine kinase
timeFrame: 24 months
measure: Peak-levels of elevated creatine kinase
timeFrame: 24 months
measure: Peak-levels of troponin
timeFrame: 30 days
measure: Peak-levels of urine myoglobin
timeFrame: 30 days
measure: Rate of muscle hyperechogenicity
timeFrame: 24 months
measure: Peak-muscle hyperechogenicity
timeFrame: 24 months
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
References: