NCT05293561

Brief Summary

SARS-COV-2 (severe acute respiratory syndrome- corona virus - 2) infection reframed medical knowledge in many aspects, yet there is still a lot to be discovered. Coronavirus disease 19 (COVID-19) can cause neuropsychiatric, psychological and psychosocial impairments. Literature regarding cognitive impact of COVID-19 is still limited. Objective: evaluation of cognitive function, anxiety and depression among patients with Coronavirus disease 19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

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

June 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

March 22, 2022

Last Update Submit

January 30, 2024

Conditions

Keywords

COVID-19; Cognitive Impairment; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

  • Cognitive impairment

    degree of affection in cognition due to COVID-19 infection

    1 month

Secondary Outcomes (1)

  • Level of Anxiety and depression among COVID-19 cases

    1 month

Study Arms (2)

COVID-19 cases

O2 saturation readings, Mini-mental state examination (MMSE), Hamilton's anxiety (HAM-A) Hamilton's depression rating scales (HAM-D)

control

O2 saturation readings, Mini-mental state examination (MMSE), Hamilton's anxiety (HAM-A) Hamilton's depression rating scales (HAM-D)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COVID-19 patients diagnosed using Real Time-Polymerase Chain Reaction to confirm the diagnosis and healthy control belonging to either gender. COVID-19 patients recruited from home isolation at first visit in outpatient clinic and then after end of isolation period for 14 days, patients included from hospital isolation ward; also recruited from the respiratory isolation ICU, chest department of Assiut university hospital.

You may qualify if:

  • COVID-19 patients diagnosed using Real Time-Polymerase Chain Reaction to confirm the diagnosis

You may not qualify if:

  • neurological disorders, psychological disorders, dementia, Alzheimer's disease, end-organ failure conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 711111, Egypt

Location

Related Publications (2)

  • Alemanno F, Houdayer E, Parma A, Spina A, Del Forno A, Scatolini A, Angelone S, Brugliera L, Tettamanti A, Beretta L, Iannaccone S. COVID-19 cognitive deficits after respiratory assistance in the subacute phase: A COVID-rehabilitation unit experience. PLoS One. 2021 Feb 8;16(2):e0246590. doi: 10.1371/journal.pone.0246590. eCollection 2021.

    PMID: 33556127BACKGROUND
  • Germani A, Buratta L, Delvecchio E, Gizzi G, Mazzeschi C. Anxiety Severity, Perceived Risk of COVID-19 and Individual Functioning in Emerging Adults Facing the Pandemic. Front Psychol. 2020 Dec 7;11:567505. doi: 10.3389/fpsyg.2020.567505. eCollection 2020.

    PMID: 33364996BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionCOVID-19Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehavior

Study Officials

  • Waleed Gamal elddin, MD

    Assiut university hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Chest diseases and tuberculosis

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 24, 2022

Study Start

June 1, 2021

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations