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Chronic Fatigue Etiology and Recovery in Covid-19 Patients: the Role of Fatigability (FatCovid-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04363606
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
University of Saint-Etienne
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This symptom seems particularly pronounced in Covid-19 patients and may affect their quality of life by decreasing their capacity to perform simple tasks of daily life.

The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in the feeling of fatigue of Covid-19 patients. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology and its recovery will allow to optimize rehabilitation treatments to shorten the persistence of chronic fatigue and in fine improve life quality.


Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Intensive Care Unit Muscle Other: Questionnaires Biological: blood test Other: Maximal effort test Device: actigraphy Device: Neuromuscular evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Chronic Fatigue Etiology and Recovery in Covid-19 Patients : the Role of Fatigability and Stay in Intensive Care
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: "Non-fatigued" patients who have been in intensive care units Other: Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep

Biological: blood test
complete blood count and cytokine concentration

Other: Maximal effort test
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.

Device: actigraphy
assessment of sleep quality

Device: Neuromuscular evaluation
  • The maximum isometric force produced by the knee extensors will be measured on the ergometer
  • the intensity of muscular electrical activity recorded by surface electromyography
  • Peripheral nerve stimulation
  • Transcranial magnetic stimulation
  • Magnetic resonance imaging

Experimental: "Fatigued" patients who have been in intensive care units Other: Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep

Biological: blood test
complete blood count and cytokine concentration

Other: Maximal effort test
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.

Device: actigraphy
assessment of sleep quality

Device: Neuromuscular evaluation
  • The maximum isometric force produced by the knee extensors will be measured on the ergometer
  • the intensity of muscular electrical activity recorded by surface electromyography
  • Peripheral nerve stimulation
  • Transcranial magnetic stimulation
  • Magnetic resonance imaging

Experimental: patients who have not been in intensive care units Other: Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep

Biological: blood test
complete blood count and cytokine concentration

Other: Maximal effort test
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.

Device: actigraphy
assessment of sleep quality

Device: Neuromuscular evaluation
  • The maximum isometric force produced by the knee extensors will be measured on the ergometer
  • the intensity of muscular electrical activity recorded by surface electromyography
  • Peripheral nerve stimulation
  • Transcranial magnetic stimulation
  • Magnetic resonance imaging




Primary Outcome Measures :
  1. voluntary maximum force reduction [ Time Frame: 6 weeks post-discharge ]

Secondary Outcome Measures :
  1. Neuromuscular function : cortical activity [ Time Frame: 6 weeks post-discharge ]
    Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation

  2. Neuromuscular function : Peripheral function [ Time Frame: 6 weeks post-discharge ]
    Peripheral function by electrical nerve stimulation

  3. Maximal oxygen uptake (VO2max) [ Time Frame: 6 weeks post-discharge ]
    measured by effort test

  4. quality of sleep [ Time Frame: 6 weeks post-discharge ]
    measured by actigraphy

  5. muscle volume [ Time Frame: 6 weeks post-discharge ]
    with Magnetic resonance imaging

  6. metabolic fatigue [ Time Frame: 6 weeks post-discharge ]
    measured by a Phosphorus 31 Nuclear magnetic resonance test



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for patients who have been in intensive care :

  • Diagnosed with Covid-19
  • Ventilated in ICU for at least 3 consecutive days
  • ICU discharge between 4 and 8 weeks
  • Approval received from a physician
  • Command of the French language

Inclusion Criteria for patients who have NOT been in intensive care :

  • Diagnosed with Covid-19 : positive serological test or positive PCR test following nasopharyngeal swabbing
  • Approval received from a physician
  • Command of the French language

Exclusion Criteria:

  • Taking neuroactive substances that can alter corticospinal excitability
  • Patients with co-morbidities leading to significant fatigue: e.g. cancerous pathologies, sleep apnea
  • Patients with neurodegenerative or neuromuscular disease
  • Contraindication to the application of a magnetic field
  • Contraindication to the practice of Magnetic Resonance Imaging
  • Participant is pregnant
  • Patients with psychiatric disorders
  • Paraplegic and hemiplegic patients
  • Addictive disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363606


Contacts
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Contact: Jérome MOREL, MD PhD 0477828553 ext +33 jerome.morel@chu-st-etienne.fr

Locations
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France
CHU de Grenoble Not yet recruiting
Grenoble, France
Contact: Pierre BOUZAT, MD PhD         
Principal Investigator: Pierre BOUZAT, MD PhD         
Sub-Investigator: Renaud TAMISIER, MD PhD         
Sub-Investigator: Stéphane DOUTRELEAU, MD PhD         
Clinique de la Sauvegarde - Lyon Not yet recruiting
Lyon, France
Contact: Olivier DESEBBE, MD         
Principal Investigator: Olivier DESEBBE, MD         
Hôpital Croix Rousse - HCL Not yet recruiting
Lyon, France
Contact: Céline GUICHON, MD         
Sub-Investigator: Céline GUICHON, MD         
Sub-Investigator: Mélanie PRUDENT, MD         
Sub-Investigator: Emeric STAUFFER, MD         
Centre Hospitalier de Lyon Sud Recruiting
Pierre-benite, France, 69310
Contact: Sébastien COURAUD, MD PhD         
Principal Investigator: Sébastien COURAUD, MD PhD         
Chu Saint-Etienne Recruiting
Saint Etienne, France, 42055
Contact: Jérome MOREL, MD PhD    (0)477828553 ext +33    jerome.morel@chu-st-etienne.fr   
Sub-Investigator: Pierre CROISILLE, MD PhD         
Sub-Investigator: Léonard FEASSON, MD PhD         
Principal Investigator: Jérôme MOREL, MD PhD         
Principal Investigator: Guillaume THIERY, MD PhD         
Sub-Investigator: Pascal GIRAUX, MD         
Sub-Investigator: Lydia OUJAMAA, MD         
Sub-Investigator: Clément Foschia, MD         
Sub-Investigator: Marine Sorg, MD         
Clinique Mutualiste Saint Etienne Not yet recruiting
Saint Etienne, France, 42100
Contact: Vincent GAUTHIER, MD         
Principal Investigator: Vincent GAUTHIER, MD         
Hôpital Henry Gabrielle Recruiting
Saint-Genis-Laval, France, 69230
Contact: Sophie JACQUIN-COURTOIS, MD PhD         
Principal Investigator: Sophie JACQUIN-COURTOIS, MD PhD         
Hôpital privé de la Loire Not yet recruiting
Saint-Étienne, France, 42000
Principal Investigator: Laurent GERGELE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
University of Saint-Etienne
Investigators
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Principal Investigator: Jérome MOREL, MD PhD CHU de Saint Etienne
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04363606    
Other Study ID Numbers: 20CH085
2020-A00982-37 ( Other Identifier: ANSM )
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Neuromuscular function
Fatigability
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Fatigue
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases