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Long-term Neurocognitive and Psychiatric Consequences in Severe COVID-19 Survivors. (NPQCOVID)

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: NCT05019300
Recruitment Status : Recruiting
First Posted : August 24, 2021
Last Update Posted : August 31, 2021
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Constanza Caneo, Pontificia Universidad Catolica de Chile

Brief Summary:
Long-term neurocognitive and psychiatric consequences of COVID-19 remain mostly unknown to date. It has been reported that coronaviruses cause direct central nervous system infection (Needham et al. 2020). Besides that, new or worsening cognitive impairment commonly occurs and persists in survivors of intensive care unit (ICU) stay (Hosey & Needham. 2020). The purpose of our study is to search and describe the cognitive and psychiatric long-term consequences of COVID-19 on patients who have been discharged from critical care units. This is an ambidirectional cohort study, that attempts to follow adults discharged from critical Care Units Adults due to COVID-19 up to 12 months after discharge, to evaluate the presence of cognitive impairment, linguistic and phonation function, depression, fatigue, functional gastroenterological symptoms, anxiety, or post traumatic disorder, and performance in activities of daily living and physical response to exercise as well.

Condition or disease Intervention/treatment
Covid19 Neurocognitive Dysfunction Biological: Exposure: COVID-19 severity

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Neurocognitive and Psychiatric Consequences of COVID-19 in Patients Discharged From Critical Care Units. A Cohort Study of the Advance Interdisciplinary Rehabilitation Register (AIRR) Covid-19 Working Group.
Actual Study Start Date : May 24, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COVID-19 patients discharged from critical care units
Adults over 18 years of age who have been hospitalized after COVID-19 diagnosis in the critical care units of Red Salud UC Christus who have been cognitively evaluated with Montreal Cognitive Assessment (MoCA) days prior to their discharge. All patients with a previous history of confirmed neurocognitive or psychotic disorders, prior to hospital admission, were excluded.
Biological: Exposure: COVID-19 severity
COVID-19 severity between 4 to 7 points according the seven-category scale of clinical status reported by Huang et al. (2021) and severe to critical symptomatic levels on spectrum of disease reported by Wu and McGoogan (2020).




Primary Outcome Measures :
  1. Cognitive impairment screening [ Time Frame: 12 months ]

    Montreal Cognitive Assessment (MoCA®). Evaluation of cognitive domains (visuospatial, executive function; attention and memory; orientation; language).

    Min score: 0 Max score: 30 Cut-off for chilean population: < 21 for mild cognitive impairment. < 20 for dementia

    Setting: Home and online



Secondary Outcome Measures :
  1. Cognitive performance [ Time Frame: 12 months ]

    Cambridge Neuropsychological Test Automated Battery (CANTAB®)

    Included tests:

    Reaction time test, (RTI) Paired associate learning (PAL) Spatial Working Memory (SWM) Spatial Span (SSP) Rapid Visual Information Processing (RVP) Cambridge Gambling Task (CGT) Intra/Extra Dimensional Set Shift (IED) Stockings of Cambridge (SOC)

    Scores: z-scores normalized by sex and educational level

    Setting: Home


  2. Neurological Soft Signs [ Time Frame: 12 months ]

    Test: Heidelberg Neurological Soft Signs Scale

    16 items on five factors ("motor coordination": Ozeretzki's test, diadochokinesis, pronation/supination, finger-to-thumb opposition, speech and articulation; "sensory integration": gait, tandem walking, two-point discrimination; "complex motor tasks": finger-to-nose test, fist-edge-palm test; "right/left and spatial orientation": right/left orientation, graphesthesia, face-hand test, stereognosis; "hard signs": arm holding test, mirror movements). All items except for gait, tandem gait, Ozeretzki's test, speech and articulation and right/left orientation are assessed separately for both, right and left sites respectively. Ratings are given on a 0-3 point scale (no/slight/moderate/marked abnormality).

    Higher scores mean worse outcomes. Min score: 0 Max score: 48 No cut-off point established in the literature.

    Setting: Home


  3. Anxiety [ Time Frame: 12 months ]

    Test: Generalized Anxiety Disorder-7 score

    The seven items assess (1) feeling nervous, anxious, or on edge; (2) being able to stop or control worrying; (3) worrying too much about different things; (4) trouble relaxing; (5) being restless; (6) becoming easily annoyed or irritable; and (7) feeling afraid as if something awful might happen.

    Increasing scores on the scale are strongly associated with multiple domains of functional impairment and increasing anxiety.

    The cut-off point suggested is of ≥10 Min score: 0 Max score: 21

    Setting: online


  4. Depressive syndrome [ Time Frame: 12 months ]

    Test: Patient Health Questionary-2 (PHQ-2) score for screening of depressive syndrome

    The cut-off point suggested is of ≥3 Min score: 0 Max score: 6

    Setting: online


  5. Post Traumatic Stress Disorder [ Time Frame: 12 months ]

    Test: Post Traumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) score

    20-item self-report measure that assesses the 20 DSM-5 symptoms of Post Traumatic Stress Disorder.

    The cut-off point suggested is of ≥33 Min score: 0 Max score: 80

    Setting: online


  6. Physical disability [ Time Frame: 12 months ]

    Test: Barthel Index score

    Measures physical disability behaviour relating to activities of daily living.

    Scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.

    Setting: online


  7. Exercise endurance [ Time Frame: 12 months ]

    Performance on 6 minutes- walk test

    Evaluation of aerobic capacity and exercise endurance.

    Setting: Home


  8. Fatigue [ Time Frame: 12 months ]

    Measured by the Modified fatigue impact scale (MFIS). The MFIS is a modified version of the 40-item Fatigue Impact Scale (FIS), which was originally developed to assess the effects of fatigue on quality of life in patients with chronic diseases. The FIS has patients rate the extent to which fatigue has affected their life in the past 4 weeks on a questionnaire consisting of 10 "physical" items, 10 "cognitive" items, and 20 "social" items, with 0 indicating "no problem" and 4 indicating "extreme problem."

    The cut-off point suggested is of ≥38 Min score: 0 Max score: 160

    Setting: online


  9. Global functionality [ Time Frame: 12 months ]

    Post-Covid-19 functional scale 5 levels of severity, where o is non impairment and 5 is the highest level of impairment.

    Setting: online


  10. Quality of life related to health [ Time Frame: 12 months ]

    Test: The 5-level EuroQol 5D health questionnaire. (EQ-5D-5L) Self rated.

    Min score: 0 Max score: 100 highest score means worst quality of life.

    Setting: online


  11. Muscle strength [ Time Frame: 12 months ]
    Dynamometry Setting: Home

  12. Pain severity [ Time Frame: 12 months ]

    Scale: Stanford pain scale

    Min: 0 represents no pain Max: 10 represents unimaginable or unspeakable pain Setting: online


  13. Spontaneous Speech [ Time Frame: 12 months ]

    Spontaneous Speech is a useful research tool to assess the scope of language disorders in people with neurological deficits. Short samples be analyzed during a brief interview and based of 10 linguistics parameters, it will characterized level and the type of language deficit. The 10 linguistic parameters are based on the ALEA method

    Setting: Home and online


  14. Verbal fluency [ Time Frame: 12 months ]

    Verbal fluency (phonological and sematic) will be assed by requesting the participants to elicit word under 1 minute for letter F, A and S and for the category animals.

    Setting: Home and online


  15. complex post-traumatic stress disorder [ Time Frame: 12 months ]

    Test: International Trauma Questionnaire self-report measure for post-traumatic stress disorder (PTSD) and complex post-traumatic stress disorder (CPTSD), corresponding to the diagnostic criteria in the International Classification of Diseases, 11th Revision (ICD-11).

    Setting: online


  16. irritable bowel syndrome [ Time Frame: 12 months ]
    Rome IV criteria Setting: online

  17. Insomnia [ Time Frame: 12 months ]

    Scale: Pittsburgh insomnia rating scale

    Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

    Setting: online


  18. Dysautonomia [ Time Frame: 12 months ]

    Scales: Scales for outcomes in Parkinson's dysfunction-autonomic (SCOPA-AUT), Orthostatic hypotension symptom assessment (OHSA) and Orthostatic hypotension activity scale (OHACT).

    Setting: online


  19. Dyspnea [ Time Frame: 12 months ]

    Test: Chronic obstructive pulmonary disease (COPD) assessment test (CAT).

    Min: 0 Max: 40 CAT ≥10 corresponds to either GOLD Group B or D. Group B patients' preferred treatment is to start either on LABA, or LAMA and if persistent symptoms then combination LAMA/LABA therapy-these are the minimum for patients with CAT Score ≥10.

    CAT <10 corresponds to GOLD Group A or C. Group A patients' preferred treatment is to start bronchodilator (LABA or LAMA) and evaluate the effect.

    Setting: online




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COVID-19 patients over 18 years of age discharged from critical care units at Red de Salud UC Christus who presented MoCA® cognitive test result less than 26 points at the time of discharge.
Criteria

Inclusion Criteria:

  • Adults over 18 years of age who have been hospitalized at critical care units, who were admitted for a diagnosis of COVID-19 and who present a score on the MOCA® cognitive test of less than 26 points at the time of hospital discharge .

Exclusion Criteria:

  • History of underlying cognitive disorder. History of underlying primary psychotic disorder. MOCA® cognitive test score greater than or equal to 26 points at the time of hospital discharge.

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): NCT05019300


Contacts
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Contact: Constanza Caneo, MD +56942909250 cmcaneo@uc.cl
Contact: Carolina Mendez, PhD +56 942595693 carolinamendez@uc.cl

Locations
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Chile
Centro de Investigaciones Médicas, Centro de Investigación Clínica UC, Hospital Clínico UC, San Carlos de Apoquindo, Departamento de Ciencias de la Salud, Escuela de Medicina, Red UC-Christus, Campus Clínico San JoaPontificia Universidad Catolica de Chile Recruiting
Santiago, Chile, 8320000
Contact: Constanza Caneo, MD    +56942909250    cmcaneo@uc.cl   
Contact: Carolina Mendez-Orellana, PhD    +56 942595693    carolinamendez@uc.cl   
Sub-Investigator: Felipe Leon, MD         
Sub-Investigator: Francisco Palacios, MD         
Principal Investigator: Carolina Astudillo, PhD         
Principal Investigator: Felix Bacigalupo, PhD         
Principal Investigator: Claudia Gonzalez, PhD         
Principal Investigator: Bernardita Soler, PhD         
Principal Investigator: Jaime Godoy, MD         
Principal Investigator: Sebastian Bravo, MD         
Principal Investigator: Claudia Saez, MD         
Principal Investigator: Luis Rojas, PhD         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Director: Rafael Medina, PhD Pontificia Universidad Catolica de Chile
Study Director: Arnoldo Riquelme, PhD Pontificia Universidad Catolica de Chile
Principal Investigator: Constanza Caneo, MD Pontificia Universidad Catolica de Chile
Principal Investigator: Carolina Mendez, PhD Pontificia Universidad Catolica de Chile
Publications:

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Responsible Party: Constanza Caneo, Clinical Assistant Professor, C-L Psychiatrist, PI NPQCOVID, Advance Interdisciplinary Rehabilitation Register, (AIRR) Covid-19 Working group, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT05019300    
Other Study ID Numbers: 0000001
1U19AI135972 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We are available to be contacted by researchers aiming to conduct secondary analyses based on our study, after providing a study protocol based on international guidelines, in order to ensure adequate use of our data.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: January 2024
Access Criteria: contact to responsable researcher C Caneo

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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 Constanza Caneo, Pontificia Universidad Catolica de Chile:
COVID-19
Intensive Care Units
Functionality
Fatigue
Anxiety
Insomnia
Long-term cognitive impairment
language disorders
Verbal fluency
Depression
Post traumatic stress
exercise endurance
Additional relevant MeSH terms:
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COVID-19
Cognitive Dysfunction
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders