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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367350
• Other study ID #: 246/2020BO2
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID
• Infection
• Myocarditis
• Myositis
• Sars-CoV2
• Severe Acute Respiratory Syndrome
• Virus Diseases

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