NCT04771624

Brief Summary

As it is evident that Covid-19 may have some impacts on cognition, the primary aim of this study is to investigate -if any- deficits of attention, working memory and executive functions after Covid-19.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

February 22, 2021

Last Update Submit

November 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological test scores

    Neuropsychological test scores of Covid-19 patients in comparison with healthy control subjects

    Up to 90 days

Secondary Outcomes (1)

  • Severity of the disease

    Up to 90 days

Study Arms (2)

Patients

Subjects who have been Covid positive by RT-PCR at least 60 days ago and not having any symptoms of Covid-19 at the moment

Healthy

Subjects who do not have any general medical, neurological or psychiatric disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In this study, 50 healthcare personnel diagnosed as Covid-19 by RT-PCR treated at the Department of Infectious Diseases, Gazi Yaşargil Tranining and Research Hospital, Sağlık Bilimleri Üniversitesi, Diyarbakır, have been randomly recorded and followed up for 60 days, and age, sex, education level and professionally matched 50 healthy subjects randomly recruited from the personnel of the same hospital.

You may qualify if:

  • Covid-19 patients:
  • Diagnosed as Covid-19 by RT-PCR at least 60 days but not more than 90 days ago
  • Asymptomatic at the moment
  • Not having any other general medical, neurological or psychiatric conditions except Covid-19 at the time of acute infection
  • Healthy subjects:
  • Not having any of Covid-19 symptoms at the testing time point
  • Not having any general medical, neurological or psychiatric condition

You may not qualify if:

  • Covid-19 patients:
  • Diagnosed as Covid-19 by RT-PCR less than 60 days or more than 90 days ago
  • Having any symptom of acute phase of Covid-19
  • Having any other general medical, neurlogical or psychiatric contidions
  • Healthy subjects:
  • Having any of Covid-19 symptoms at the testing time point
  • Having any general medical, neurological or psychiatric condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

Location

Related Publications (3)

  • Wilson BA, Betteridge S, Fish J. Neuropsychological consequences of Covid-19. Neuropsychol Rehabil. 2020 Oct;30(9):1625-1628. doi: 10.1080/09602011.2020.1808483. No abstract available.

    PMID: 32869697BACKGROUND
  • Zhou H, Lu S, Chen J, Wei N, Wang D, Lyu H, Shi C, Hu S. The landscape of cognitive function in recovered COVID-19 patients. J Psychiatr Res. 2020 Oct;129:98-102. doi: 10.1016/j.jpsychires.2020.06.022. Epub 2020 Jun 30.

    PMID: 32912598BACKGROUND
  • Guo Q, Zheng Y, Shi J, Wang J, Li G, Li C, Fromson JA, Xu Y, Liu X, Xu H, Zhang T, Lu Y, Chen X, Hu H, Tang Y, Yang S, Zhou H, Wang X, Chen H, Wang Z, Yang Z. Immediate psychological distress in quarantined patients with COVID-19 and its association with peripheral inflammation: A mixed-method study. Brain Behav Immun. 2020 Aug;88:17-27. doi: 10.1016/j.bbi.2020.05.038. Epub 2020 May 19.

    PMID: 32416290BACKGROUND

MeSH Terms

Conditions

COVID-19Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Mehmet D Güleken, MD

    Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

October 30, 2020

Primary Completion

April 30, 2021

Study Completion

November 1, 2021

Last Updated

November 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

All the data of the participants is being declared as it will be preserved, in the informed consent at the point of enrollment

Locations