Prospective Registry of Corona Virus Disease 2019 (Covid-19) Patients With Neuromuscular Involvement
Prospective Registry for Multimodal Assessment of Neuromuscular Pathology Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2020
CompletedFirst Submitted
Initial submission to the registry
April 28, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedApril 29, 2020
April 1, 2020
1 year
April 28, 2020
April 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Rate of elevated creatine kinase
24 months
Rate of two-peak elevation of creatine kinase during acute phase
30 days
Rate of myositis-specific antibodies
24 months
Rate of antimyocardial antibodies
24 months
Area under the curve (AUC) of elevated creatine kinase
24 months
- +5 more secondary outcomes
Interventions
creatine kinase, troponin, urine myoglobin, and autoimmune antibodies
Muscle echogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score)
Eligibility Criteria
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.
You may qualify if:
- Age ≥ 18 years
- Proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
You may not qualify if:
- active or known history of myopathy or advanced stage neuropathy
- refusal to participate in clinical research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Tuebingen
Tübingen, 72076, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2020
First Posted
April 29, 2020
Study Start
March 20, 2020
Primary Completion
March 31, 2021
Study Completion
March 31, 2022
Last Updated
April 29, 2020
Record last verified: 2020-04