Neuropsychological Sequelae and Long COVID-19 Fatigue (PostCoV2Psy)

Centro Hospitalar Universitario do Algarve

Status: Enrolling

Conditions: COVID-19; Fatigue Syndrome, Chronic; Anxiety Depression; Post Traumatic Stress Disorder; Mental Fatigue

Treatments: Other: Neuropsychological Sequelae

Study type: Observational

Funder types: Other

Identifiers

NCT05323318

141/21

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Neuropsychological Sequelae

Description:

Post-COVID-19 symptomatic patients with neuropsychological sequelae

Treatment:

Other: Neuropsychological Sequelae

Without Neuropsychological Sequelae

Description:

Post-COVID-19 symptomatic patients Without neuropsychological sequelae