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COVIDNCT04397172

Intensive Care Associated Complications and Outcome of Acute Respiratory Distress Syndrome Due to COVID-19

An observational study of COVID and Corona Virus Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

COVID-19 patients with a severely symptomatic progression with development of an Acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing Critical… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
COVID, Corona Virus Infection, Sars-CoV2
What is being tested?
Study Arm
Type of treatment
Surgery or procedure
How many people
48 participants
Where
1 siteSwitzerland
Study dates
9 Apr 2020to 27 Nov 2023
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The present study aims to prospectively evaluate the incidence and severity of CIM in patients with ARDS due to SARS-CoV-2. The investigators therefore conduct a study including patients with ARDS admitted to the intensive care unit (ICU) due to the novel COVID-19 disease (SARS-CoV-2). The investigators plan to analyze 50 full data sets of ICU patients (regarding primary endpoint), out of which about 30-50% will be expected to develop CIM. There is no alternative group of patients with whom this study could be conducted.

Who may be able to join

  • Informed consent as documented by a surrogate assessment by an independent physician
  • Adult ICU Patients with ARDS due to SARS-CoV-2 requiring mechanical ventilation

Who cannot join

  • Age <18 years and > 80 years
  • Pregnancy and breast feeding
  • The presence of pre-existing:
  • Known (at time of inclusion) Polyneuropathy,
  • Known (at time of inclusion) Guillain-Barré syndrome,
  • Known (at time of inclusion) Acute or chronic spinal cord lesion,
  • Known (at time of inclusion) Myasthenia gravis, or
  • Known (at time of inclusion) Myopathy

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Inselspital Bern

    Bern, 3010

Other trials in Switzerland

About this study

Official title: Characterization of ARDS, Critical Illness Myopathy and Their Long-term Consequences in Patients With Covid-19 Disease: Effects of Inflammation, Mitochondrial Dysfunction and Plasma Concentrations of Various Sedative Drugs

COVID-19 patients with a severely symptomatic progression with development of an Acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing Critical illness myopathy (CIM). CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using (Muscle velocity recovery cycles) MRVC measurements.

The primary endpoint is the incidence of CIM in patients with ARDS due to SARS-CoV-2, diagnosed according to the current diagnostic criteria.

Read the detailed description

COVID-19 patients with a severely symptomatic progression with development of an ARDS due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing CIM. CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using MRVC measurements.

Objective:

The primary objective of this project is to prospectively evaluate the incidence and severity of CIM in patients with ARDS due to SARS-CoV-2.

The secondary objectives of this project include:

  1. To assess the quality of life of patients with and without CIM after ARDS due to SARS-CoV-2.
  2. To monitor changes in muscle excitability parameters in critically ill patients with ARDS due to SARS-CoV-2 in relation to a later confirmed diagnosis of CIM according to the current standards.
  3. To explore underlying pathophysiological processes for CIM (mitochondrial dysfunction, medication e.g. Neuromuscular blocking agents (NMBA), sedative drugs, and metabolic (amino acids, inflammatory parameters)).

Method:

After enrolment in the study, patients will be examined for the first time within 24 hours after admission to the ICU, and follow-up visits will be performed at day 2, 5 and 10 or upon termination of therapy with NMBA, respectively. The endpoint will be at the clinical follow-up appointment.

Being tested
Study Arm
Keywords
Corona, SARS-CoV2, ARDS, PICS
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Study ArmProcedure or surgery

    First inpatient examination (within 24 hours after admission to ICU):

    • Clinical examination
    • Laboratory tests, Biobanking, Mitochondrial function testing
    • Neurophysiological examination (MVRC recording)

    Follow-up inpatient examinations (day 2, 5 and 10 after admission):

    • Clinical examination
    • Laboratory tests, Biobanking, Mitochondrial functions testing
    • Neurophysiological examination (MVRC recording)
    • Day 10 only: Extended neurophysiological examination according to diagnostic criteria
    • Day 10 only: Grading of muscle strength (Medical Research Council (MRC) system)

    Follow-up outpatient examination (after discharge from intensive care):

    • Clinical examination
    • Grading of muscle strength (MRC)
    • Modified Rankin Scale (mRS)
    • Barthel Scale
    • Questionnaires (Short Form (36) Health Survey, Essener Questionnaire for Coping with a Disease and Beck's Depression Inventory II)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short Form (36) Health Survey (SF-36)

    Short Form (36) Health Survey (SF-36)

    Measured: 3 months

Secondary outcomes (7)

  1. Mortality

    Mortality

    Measured: 90 days

  2. Modified Rankin Scale (mRS)

    Modified Rankin Scale (mRS); (0=no Symptoms at all, 6=dead)

    Measured: 90 days

  3. Duration of mechanical ventilation in days

    Duration of mechanical ventilation in days

    Measured: 3 months

  4. Barthel Index

    Barthel Index (80-100= patient should be able to live independently, <20=total dependence)

    Measured: 3 months

  5. Beck's Depression Inventory II (BDI-II)

    Beck's Depression Inventory II (BDI-II)

    Measured: 3 months

  6. Essener Questionnaire for Coping with a Disease (EFK)

    Essener Questionnaire for Coping with a Disease (EFK); (0=no burden of disease, 180-strong burden of disease)

    Measured: 3 months

  7. Number of patients with Critical Illness Myopathy

    Number of patients with Critical Illness Myopathy

    Measured: day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start9 Apr 2020
  3. Primary completion31 Oct 2023
  4. Study completion27 Nov 2023

Why it stopped: Number of Covid-19 cases who need intensive care have greatly reduced, it is very difficult to find eligible patients for the study

Resources

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04397172
Sponsor's protocol ID
2020-00730
Status last verified
Nov 2023
First submitted
20 May 2020
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Belgnaoui SM, Paz S, Hiscott J. Orchestrating the interferon antiviral response through the mitochondrial antiviral signaling (MAVS) adapter. Curr Opin Immunol. 2011 Oct;23(5):564-72. doi: 10.1016/j.coi.2011.08.001. Epub 2011 Aug 22.

    PubMed 21865020

  • Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

    PubMed 32007143

  • Dinglas VD, Aronson Friedman L, Colantuoni E, Mendez-Tellez PA, Shanholtz CB, Ciesla ND, Pronovost PJ, Needham DM. Muscle Weakness and 5-Year Survival in Acute Respiratory Distress Syndrome Survivors. Crit Care Med. 2017 Mar;45(3):446-453. doi: 10.1097/CCM.0000000000002208.

    PubMed 28067712

  • De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.

    PubMed 12472328

  • de Letter MA, Schmitz PI, Visser LH, Verheul FA, Schellens RL, Op de Coul DA, van der Meche FG. Risk factors for the development of polyneuropathy and myopathy in critically ill patients. Crit Care Med. 2001 Dec;29(12):2281-6. doi: 10.1097/00003246-200112000-00008.

    PubMed 11801825

  • Griffiths J, Hatch RA, Bishop J, Morgan K, Jenkinson C, Cuthbertson BH, Brett SJ. An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Crit Care. 2013 May 28;17(3):R100. doi: 10.1186/cc12745.

    PubMed 23714692

  • Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

    PubMed 21470008

  • James MA. Use of the Medical Research Council muscle strength grading system in the upper extremity. J Hand Surg Am. 2007 Feb;32(2):154-6. doi: 10.1016/j.jhsa.2006.11.008. No abstract available.

    PubMed 17275587

  • Lacomis D. Electrophysiology of neuromuscular disorders in critical illness. Muscle Nerve. 2013 Mar;47(3):452-63. doi: 10.1002/mus.23615. Epub 2013 Feb 6.

    PubMed 23386582

  • Latronico N, Bolton CF. Critical illness polyneuropathy and myopathy: a major cause of muscle weakness and paralysis. Lancet Neurol. 2011 Oct;10(10):931-41. doi: 10.1016/S1474-4422(11)70178-8.

    PubMed 21939902

  • Liu Y, Yan LM, Wan L, Xiang TX, Le A, Liu JM, Peiris M, Poon LLM, Zhang W. Viral dynamics in mild and severe cases of COVID-19. Lancet Infect Dis. 2020 Jun;20(6):656-657. doi: 10.1016/S1473-3099(20)30232-2. Epub 2020 Mar 19. No abstract available.

    PubMed 32199493

  • Shi CS, Qi HY, Boularan C, Huang NN, Abu-Asab M, Shelhamer JH, Kehrl JH. SARS-coronavirus open reading frame-9b suppresses innate immunity by targeting mitochondria and the MAVS/TRAF3/TRAF6 signalosome. J Immunol. 2014 Sep 15;193(6):3080-9. doi: 10.4049/jimmunol.1303196. Epub 2014 Aug 18.

    PubMed 25135833

  • Weber-Carstens S, Deja M, Koch S, Spranger J, Bubser F, Wernecke KD, Spies CD, Spuler S, Keh D. Risk factors in critical illness myopathy during the early course of critical illness: a prospective observational study. Crit Care. 2010;14(3):R119. doi: 10.1186/cc9074. Epub 2010 Jun 18.

    PubMed 20565863

  • Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.

    PubMed 32085846

  • Z'Graggen WJ, Brander L, Tuchscherer D, Scheidegger O, Takala J, Bostock H. Muscle membrane dysfunction in critical illness myopathy assessed by velocity recovery cycles. Clin Neurophysiol. 2011 Apr;122(4):834-41. doi: 10.1016/j.clinph.2010.09.024. Epub 2010 Nov 1.

    PubMed 21044861

Questions about this trial

What is this clinical trial studying?

An observational study of COVID and Corona Virus Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

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 8 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: stopped early, as of the sponsor's last update on 6 Dec 2023. 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 Switzerland. 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?

The study was stopped early (reason given: Number of Covid-19 cases who need intensive care have greatly reduced, it is very difficult to find eligible patients for the study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Form (36) Health Survey (SF-36) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04397172, which also lists 15 linked publications.

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 6 Dec 2023.

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