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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04367350
Other study ID # 246/2020BO2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 20, 2020
Est. completion date March 31, 2022

Study information

Verified date April 2020
Source University Hospital Tuebingen
Contact Alexander Grimm, MD
Phone +49 (0) 7071-29
Email alexander.grimm@med.uni-tuebingen.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date March 31, 2022
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
laboratory biomarkers
creatine kinase, troponin, urine myoglobin, and autoimmune antibodies
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)

Locations

Country Name City State
Germany University Hospital Tuebingen Tuebingen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of elevated creatine kinase in hyperacute phase Elevation of creatine kinase during hyperacute phase of corona virus disease 2019 (Covid-19) 1 week
Secondary Rate of elevated creatine kinase Elevation of creatine kinase during hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19) 24 months
Secondary Rate of two-peak elevation of creatine kinase during acute phase Two-peak elevation of creatine kinase during acute phase of corona virus disease 2019 (Covid-19) 30 days
Secondary Rate of myositis-specific antibodies Presence of myositis-specific antibodies on admission, at two weeks, and at end of follow-up 24 months
Secondary Rate of antimyocardial antibodies Presence of antimyocardial antibodies on admission, at two weeks, and at end of follow-up 24 months
Secondary Area under the curve (AUC) of elevated creatine kinase 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
Secondary Peak-levels of elevated creatine kinase Maximal value of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19) 24 months
Secondary Peak-levels of troponin Maximal value of troponin in the acute phase of corona virus disease 2019 (Covid-19) 30 days
Secondary Peak-levels of urine myoglobin Maximal value of urine myoglobin in the acute of corona virus disease 2019 (Covid-19) 30 days
Secondary Rate of muscle hyperechogenicity 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
Secondary Peak-muscle hyperechogenicity 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
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