Clinical trial NCT05323318: Neuropsychological Sequelae and Long COVID-19 Fatigue
Official title: Neuropsychological Sequelae as a Risk Factor for Long COVID-19 Fatigue
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety Depression
Post Traumatic Stress Disorder
Mental Fatigue
COVID-19
Fatigue Syndrome, Chronic
Keywords: SARS-CoV-2, fatigue, psychological disorders
Lead sponsor: Centro Hospitalar Universitario do Algarve
Sponsor class: OTHER
Collaborators: name: Universidade do Algarve
name: Universidade do Porto
First posted: 2022-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of fatigue in patients with post-COVID-19 depression and/or anxiety
timeFrame: 6-9 months
measure: Prevalence of fatigue in patients with post-COVID-19 post-traumatic stress disorder
timeFrame: 6-9 months
Secondary outcomes:
measure: Impact of post-COVID-19 fatigue in quality of life.
timeFrame: 6-9 months
measure: Impact of post-COVID-19 neuropsychological sequelae in quality of life
timeFrame: 6-9 months
measure: Evaluate if neuropsychological are associated with severity of acute COVID-19
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Alvor
country: Portugal
facility: Hospital Particular de Alvor
city: Amadora
country: Portugal
facility: Hospital Professor Doutor Fernando Fonseca (Hff)
city: Faro
country: Portugal
facility: Hospital de Faro (Chua)
city: Portimao
country: Portugal
facility: Hospital de Portimao
city: Santa Maria Da Feira
country: Portugal
facility: Hospital de Sao Sebastiao (Chedv)
city: Vila Franca de Xira
country: Portugal
facility: Hospital de Vila Franca de Xira (Hvfx)
Study officials:
affiliation: Centro Hospitalar Universitario do Algarve
name: Ligia Pires, MD
role: STUDY_CHAIR
affiliation: Universitat Bern
name: Joana Berger, PHD
role: STUDY_DIRECTOR
affiliation: Centro Hospitalar Universitario do Algarve
name: Ligia Pires, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade do Porto
name: Marta Drummond, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferreira LN, Ferreira PL, Pereira LN, Oppe M. The valuation of the EQ-5D in Portugal. Qual Life Res. 2014 Mar;23(2):413-23. doi: 10.1007/s11136-013-0448-z. Epub 2013 Jun 8.
citation: Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.
citation: Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147-53. doi: 10.1016/0022-3999(93)90081-p.
citation: Rasa S, Nora-Krukle Z, Henning N, Eliassen E, Shikova E, Harrer T, Scheibenbogen C, Murovska M, Prusty BK; European Network on ME/CFS (EUROMENE). Chronic viral infections in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). J Transl Med. 2018 Oct 1;16(1):268. doi: 10.1186/s12967-018-1644-y.
citation: Simani L, Ramezani M, Darazam IA, Sagharichi M, Aalipour MA, Ghorbani F, Pakdaman H. Prevalence and correlates of chronic fatigue syndrome and post-traumatic stress disorder after the outbreak of the COVID-19. J Neurovirol. 2021 Feb;27(1):154-159. doi: 10.1007/s13365-021-00949-1. Epub 2021 Feb 2.
citation: Mazza MG, De Lorenzo R, Conte C, Poletti S, Vai B, Bollettini I, Melloni EMT, Furlan R, Ciceri F, Rovere-Querini P; COVID-19 BioB Outpatient Clinic Study group; Benedetti F. Anxiety and depression in COVID-19 survivors: Role of inflammatory and clinical predictors. Brain Behav Immun. 2020 Oct;89:594-600. doi: 10.1016/j.bbi.2020.07.037. Epub 2020 Jul 30.