Neuropsychological Sequelae and Long COVID-19 Fatigue (PostCoV2Psy)

March 12, 2023 updated by: Ligia Pires, Centro Hospitalar Universitario do Algarve

Neuropsychological Sequelae as a Risk Factor for Long COVID-19 Fatigue

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Portugal
      • Alvor, Portugal, 8500-322
        • Recruiting
        • Hospital Particular de Alvor
        • Contact:
        • Contact:
          • Ligia Pires, MD
        • Sub-Investigator:
          • Armin Bidarian, PHD
      • Amadora, Portugal, 2720-276
        • Completed
        • Hospital Professor Doutor Fernando Fonseca (Hff)
      • Faro, Portugal, 8000-386
        • Completed
        • Hospital de Faro (CHUA)
      • Portimao, Portugal, 8500-338
        • Recruiting
        • Hospital de Portimao
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Claudia Reis, MD
        • Sub-Investigator:
          • Rita Falcão, MD
        • Sub-Investigator:
          • Rute Martins, MD
      • Santa Maria Da Feira, Portugal, 4520-211
        • Recruiting
        • Hospital de Sao Sebastiao (Chedv)
        • Principal Investigator:
          • Lucia Gonzalez, Nurse
      • Vila Franca de Xira, Portugal, 2600-009
        • Suspended
        • Hospital de Vila Franca de Xira (Hvfx)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted in five Portuguese Hospitals, Universitary and district, in which a follow-up post-COVID-19 medical consultation has been implemented

Description

Inclusion Criteria:

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neuropsychological Sequelae
Post-COVID-19 symptomatic patients with neuropsychological sequelae
Other: Neuropsychological Sequelae
Neuropsychological Sequelae after SARS-CoV-2 symtomatic infection
Without Neuropsychological Sequelae
Post-COVID-19 symptomatic patients Without neuropsychological sequelae

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of fatigue in patients with post-COVID-19 depression and/or anxiety
Time Frame: 6-9 months

Fatigue will be assessed with the Chalder fatigue scale:

- Global score (0-33), that also spans two dimensions-physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11). This is a Likert scoring system that allows for means and distributions to be calculated for both the global total as well as the two sub-scales.

Depression and anxiety will be assessed with the Hospital Anxiety and Depression Scale

  • Depression HADS subscale scoring: Normal 0-7; Boderline abnormal 8-10; Abnormal 11-21
  • Anxiety HADS subscale scoring: Normal 0-7; Borderline 8-10; Abnormal 11-21
6-9 months
Prevalence of fatigue in patients with post-COVID-19 post-traumatic stress disorder
Time Frame: 6-9 months

Fatigue will be assessed with the Chalder fatigue scale (global and binary score).

PTSD will be assessed with the Post-Traumatic Stress Syndrome 14 Questions Inventory (PTSS-14) adapted to COVID-19:

- Positive case between 46-98 points
6-9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of post-COVID-19 fatigue in quality of life.
Time Frame: 6-9 months

Fatigue will be assessed with the Chalder fatigue scale (binary score and global score).

Quality of live will be assessed by the original EQ-5D questionnaire, that comprises two parts:

- EQ-5D-3L, health state classification scheme of five items (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each having three alternatives (1= no problems, 2= moderate problems, and 3= severe problems). Calculating a single index score combines these five dimensions.

The index value of a particular health state thus indicates the preference for being in that health state in relation to death, which has been set equal to 0 and best possible health (eg, no problems on any of the five items) which has been set to 1.0.

- EQ VAS, a visual analog scale to health state ranging from 0 (worst possible health state) to 100 (best possible health state).
6-9 months
Impact of post-COVID-19 neuropsychological sequelae in quality of life
Time Frame: 6-9 months
Evaluate if the positive cases for anxiety, depression and/or PTSD have lower quality of live (The tools will be the same of previous outcomes).
6-9 months
Evaluate if neuropsychological are associated with severity of acute COVID-19
Time Frame: 6-9 months

Depression and anxiety will be assessed with the Hospital Anxiety and Depression Scale

  • Depression HADS subscale scoring: Normal 0-7; Boderline abnormal 8-10; Abnormal 11-21
  • Anxiety HADS subscale scoring: Normal 0-7; Borderline 8-10; Abnormal 11-21

Posttraumatic Stress Symptoms-14 instrument, adapted in this protocol for COVID-19 survivors:

- PTSS 14 scoring > 45 points

Acute COVID-19 severity will be categorized as mild illness (mild symptoms without the radiographic appearance of pneumonia), pneumonia (having symptoms and the radiographic evidence of pneumonia, with no requirement for supplemental oxygen), severe pneumonia (having pneumonia, including one of the following: respiratory rate > 30 breaths/minute; severe respiratory distress; or SpO2 ≤ 93% on room air at rest), and critical cases (e.g. respiratory failure requiring mechanical ventilation or nasal high flow oxygen, septic shock, other organ failure occurrence or admission into the ICU).
6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar Universitario do Algarve

Collaborators

Universidade do Porto
Universidade do Algarve

Investigators

  • Study Chair: Ligia Pires, MD, Centro Hospitalar Universitario do Algarve
  • Study Director: Joana Berger, PHD, Universität Bern
  • Principal Investigator: Ligia Pires, MD, Centro Hospitalar Universitario do Algarve
  • Principal Investigator: Marta Drummond, PHD, Universidade do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

March 30, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

April 8, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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