Neuropsychological Sequelae and Long COVID-19 Fatigue

Last updated: March 12, 2023
Sponsor: Centro Hospitalar Universitario do Algarve
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Post-traumatic Stress Disorders

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT05323318
141/21
  • Ages 18-95
  • All Genders

Study Summary

An association of fatigue with post-viral neuropsychological disturbs has been reported. Among patients hospitalized with COVID-19 there is an increased incidence of anxiety and depression symptoms. In addition, a quarter of patients experience at least mild symptoms of acute post traumatic stress disorder. (Mazza, M. G. et al 2020). The prevalence of chronic fatigue syndrome had a correlation with post-traumatic stress disorder (PTSD) in a study conducted after the outbreak of the COVID-19 in Iran (Silmani et al, 2021), that showed 5.8% of subjects suffering from PTSD after 6 months of SARS-CoV-2 infection onset.

In this Study we propose to use a tool to quantify the degree of physical and psychological fatigue in post-COVID-19 patients, and assess the correlation of fatigue with the neuropsychiatric sequelae in hospitalized and non hospitalized patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years;
  • Previous COVID-19 at least six months after the diagnosis duly documented in theclinical record;
  • Persistent symptoms after cure criteria defined by WHO Symptomatic patients thatattend the post-COVID-19 follow-up consultation of the study centres.
  • SARS-CoV-2 RNA confirmed by a positive real-time reverse-transcription polymerasechain reaction on a nasopharyngeal swab.
  • SARS-CoV-2 antigen confirmed on a nasopharyngeal swab, by a healthcare professional.

Exclusion

Exclusion Criteria:

  • Patients with PTSD previous diagnosis
  • Severe psychiatric disorders documented in the clinical record
  • Patients not able to respond the questionnaire
  • Patients who had a concomitant severe neurological disorder
  • Clinical and radiological diagnosis of Stroke with sequelae
  • Clinical diagnosis of Alzheimer's Disease
  • Clinical diagnosis of Parkinson's disease
  • Patients with persistent fatigue symptoms in the 6 months before SARS-CoV 2 infection

Study Design

Total Participants: 200
Study Start date:
April 01, 2022
Estimated Completion Date:
April 30, 2023

Study Description

This study will address the neuropsychiatric sequelae that remain for at least 6 months after SARS-CoV-2 acute infection, as depression, anxiety and/or post-traumatic stress disorder.

The patiensts will be assessed at the post-COVID-19 outpatient clinics of five Portuguese Hospitals. In the first visit (T1) will be collected the demographic characteristics; the medical history; and the screening of acute disease symptoms and severity. In the second visit (T2), the time frame will be at least 6 months after the positive test and no longer than 9 months, a set of structured questionnaires will be provided, including: the Chalder Fatigue Scale, Anxiety and Depression Hospital Scale (HADS), The Posttraumatic Stress Symptoms-14 (PTSS-14) adapted to COVID-19 and the EuroQol 5-Dimensions (EQ-5D).

Connect with a study center

  • Hospital Particular de Alvor

    Alvor, 8500-322
    Portugal

    Active - Recruiting

  • Hospital Professor Doutor Fernando Fonseca (Hff)

    Amadora, 2720-276
    Portugal

    Completed

  • Hospital de Faro (Chua)

    Faro, 8000-386
    Portugal

    Completed

  • Hospital Distrital Figueira Da Foz (Hdff)

    Figueira Da Foz, 3094-001
    Portugal

    Site Not Available

  • Hospital de Portimao

    Portimao, 8500-338
    Portugal

    Active - Recruiting

  • Hospital Sao Joao (Chusj)

    Porto, 4200-319
    Portugal

    Site Not Available

  • Hospital de Sao Sebastiao (Chedv)

    Santa Maria Da Feira, 4520-211
    Portugal

    Active - Recruiting

  • Hospital de Vila Franca de Xira (Hvfx)

    Vila Franca de Xira, 2600-009
    Portugal

    Suspended

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