Neuropsychological Sequelae and Long COVID-19 Fatigue

COVID-19 Clinical Trial

— PostCoV2Psy  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323318
• Other study ID #: 141/21
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2023
• Source: Centro Hospitalar Universitario do Algarve
• Contact: Ligia Pires, MD
• Phone: +351282450300
• Email: alves1029[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 30, 2023
• Est. primary completion date: March 30, 2023
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Depression
• COVID-19
• Fatigue
• Fatigue Syndrome, Chronic
• Mental Fatigue
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Neuropsychological Sequelae
Neuropsychological Sequelae after SARS-CoV-2 symtomatic infection

Locations

Country	Name	City	State
Portugal	Hospital Particular de Alvor	Alvor
Portugal	Hospital Professor Doutor Fernando Fonseca (Hff)	Amadora
Portugal	Hospital de Faro (Chua)	Faro
Portugal	Hospital de Portimao	Portimao
Portugal	Hospital de Sao Sebastiao (Chedv)	Santa Maria Da Feira
Portugal	Hospital de Vila Franca de Xira (Hvfx)	Vila Franca de Xira

Sponsors (3)

Lead Sponsor	Collaborator
Centro Hospitalar Universitario do Algarve	Universidade do Algarve, Universidade do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (6)

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. — View 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. — View 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. — View 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 p — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of fatigue in patients with post-COVID-19 depression and/or anxiety	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
Primary	Prevalence of fatigue in patients with post-COVID-19 post-traumatic stress disorder	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	Impact of post-COVID-19 fatigue in quality of life.	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
Secondary	Impact of post-COVID-19 neuropsychological sequelae in quality of life	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
Secondary	Evaluate if neuropsychological are associated with severity of acute COVID-19	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