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

• Conditions: Sars-CoV2; Corona Virus Infection; Myocarditis; Myositis; COVID

• Registration Number: NCT04367350
• Lead Sponsor: University Hospital Tuebingen

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).

Study Timeline

• Study Start: 2020-03-20
• Status Verified: 2020-04
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-28
• Last Update Submitted: 2020-04-28
• Study First Posted: 2020-04-29
• Last Update Posted: 2020-04-29
• Primary Completion: 2021-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of elevated creatine kinase in hyperacute phase	1 week	Elevation of creatine kinase during hyperacute phase of corona virus disease 2019 (Covid-19)

Secondary Outcome Measures

Name	Time	Method
Rate of two-peak elevation of creatine kinase during acute phase	30 days	Two-peak elevation of creatine kinase during acute phase of corona virus disease 2019 (Covid-19)
Rate of myositis-specific antibodies	24 months	Presence of myositis-specific antibodies on admission, at two weeks, and at end of follow-up
Rate of antimyocardial antibodies	24 months	Presence of antimyocardial antibodies on admission, at two weeks, and at end of follow-up
Area under the curve (AUC) of elevated creatine kinase	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)
Peak-muscle hyperechogenicity	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)
Rate of elevated creatine kinase	24 months	Elevation of creatine kinase during hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)
Peak-levels of elevated creatine kinase	24 months	Maximal value of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)
Peak-levels of troponin	30 days	Maximal value of troponin in the acute phase of corona virus disease 2019 (Covid-19)
Peak-levels of urine myoglobin	30 days	Maximal value of urine myoglobin in the acute of corona virus disease 2019 (Covid-19)
Rate of muscle hyperechogenicity	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)

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany