COVIDNCT04367350
Prospective Registry of Corona Virus Disease 2019 (Covid-19) Patients With Neuromuscular Involvement
An observational study of COVID and Sars-CoV2, run by University Hospital Tuebingen at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Sars-CoV2, Corona Virus Infection
- What is being tested?
- laboratory biomarkers and muscle ultrasound
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 20 Mar 2020to 31 Mar 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years
- Proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Who cannot join
- active or known history of myopathy or advanced stage neuropathy
- refusal to participate in clinical research
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen, 72076
Alexander Grimm, MD, +49 (0) 7071-29 ext. 0, alexander.grimm@med.uni-tuebingen.de
Sven Poli, MD, +49 (0) 7071-29 ext. 83269, sven.poli@uni-tuebingen.de
About this study
Official title: Prospective Registry for Multimodal Assessment of Neuromuscular Pathology Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
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.
Read the 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).
- Conditions
- COVID, Sars-CoV2, Corona Virus Infection, Myositis, Myocarditis
- Being tested
- laboratory biomarkers, muscle ultrasound
- Medical subject headings
- Coronavirus Infections, Myositis, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarkersDiagnostic test
creatine kinase, troponin, urine myoglobin, and autoimmune antibodies
muscle ultrasoundDiagnostic test
Muscle echogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score)
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of elevated creatine kinase in hyperacute phase
Elevation of creatine kinase during hyperacute phase of corona virus disease 2019 (Covid-19)
Measured: 1 week
Secondary outcomes (10)
Rate of elevated creatine kinase
Elevation of creatine kinase during hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)
Measured: 24 months
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)
Measured: 30 days
Rate of myositis-specific antibodies
Presence of myositis-specific antibodies on admission, at two weeks, and at end of follow-up
Measured: 24 months
Rate of antimyocardial antibodies
Presence of antimyocardial antibodies on admission, at two weeks, and at end of follow-up
Measured: 24 months
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)
Measured: 24 months
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)
Measured: 24 months
Peak-levels of troponin
Maximal value of troponin in the acute phase of corona virus disease 2019 (Covid-19)
Measured: 30 days
Peak-levels of urine myoglobin
Maximal value of urine myoglobin in the acute of corona virus disease 2019 (Covid-19)
Measured: 30 days
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)
Measured: 24 months
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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start20 Mar 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367350
- Sponsor's protocol ID
- 246/2020BO2
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry for Multimodal Assessment of Neuromuscular Pathology Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
- ClinicalTrials.gov ID
- NCT04367350
- Acronym / sponsor ID
- 246/2020BO2
- Conditions
- COVID, Sars-CoV2, Corona Virus Infection, Myositis, Myocarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Key exclusion criteria (2 listed)
- active or known history of myopathy or advanced stage neuropathy
- refusal to participate in clinical research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarkerscreatine kinase, troponin, urine myoglobin, and autoimmune antibodies | Diagnostic test | – |
| muscle ultrasoundMuscle echogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score) | Diagnostic test | – |
Primary outcome
Rate of elevated creatine kinase in hyperacute phase
Time frame: 1 week
Elevation of creatine kinase during hyperacute phase of corona virus disease 2019 (Covid-19)
10 secondary outcomes
Rate of elevated creatine kinase
Time frame: 24 months
Rate of two-peak elevation of creatine kinase during acute phase
Time frame: 30 days
Rate of myositis-specific antibodies
Time frame: 24 months
Rate of antimyocardial antibodies
Time frame: 24 months
Area under the curve (AUC) of elevated creatine kinase
Time frame: 24 months
Peak-levels of elevated creatine kinase
Time frame: 24 months
Peak-levels of troponin
Time frame: 30 days
Peak-levels of urine myoglobin
Time frame: 30 days
Rate of muscle hyperechogenicity
Time frame: 24 months
Peak-muscle hyperechogenicity
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Sars-CoV2, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Grimm, MD (+49 (0) 7071-29 ext. 0, alexander.grimm@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of elevated creatine kinase in hyperacute phase (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.