Cognitive Impact in Patients With COVID-19 Infection

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05293561
Collaborator
(none)
100
1
9
11.1

Study Details

Study Description

Brief Summary

SARS-COV-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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    COVID-19 results in a variety of symptoms with multi-organ affection, including fever, cough; grave respiratory symptoms, gastrointestinal manifestations and fatigue. As more is learned, neurological and psychological symptoms appear to manifest in a large subscale of patients. Headache, dizziness and even a cerebrovascular event have been reported. Anosmia and ageusia reported as early indicators of SARS-CoV-2 infection, suggesting that early neurological involvement may be relevant.

    Public health emergencies as COVID-19 are likely to cause adverse neuropsychiatric impacts. Cognitive impairments after SARS-COV-2 infection were noticed, COVID-19 patients complain of poor concentration, declined memory, and insomnia, as well as anxiety and depression symptoms.

    The battle against COVID-19 is still continuing worldwide. People's adherence to confinement regulations and response to vaccination campaigns is essential, which is largely affected by their knowledge, attitudes, and practices towards COVID-19. Home isolation and social distancing are also associated with fear, frustrations, uncertainty, anxiety and depressive symptoms.

    During the acute phase of COVID-19 infection, about 36% of cases develop neurological symptoms of which 25% can be attributed to the direct involvement of the central nervous system. Patients who show neurological symptoms included cases with or without pre-existing neurological disorders. While on intensive care units, patients showed agitation, confusion, and corticospinal tract signs such as enhanced tendon reflexes and clonus. COVID-19 can further lead to changes of coagulation and, in particular, to inflammation-induced disseminated intravascular coagulation (DIC).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Cognitive Impact in Patients With COVID-19 Infection
    Actual Study Start Date :
    Jun 1, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2022
    Anticipated Study Completion Date :
    Mar 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive impairment [1 month]

      degree of affection in cognition due to COVID-19 infection

    Secondary Outcome Measures

    1. Level of Anxiety and depression among COVID-19 cases [1 month]

      Level of Anxiety and depression among COVID-19 cases

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • covid-19 patients diagnosed using Real Time-Polymerase Chain Reaction to confirm the diagnosis
    Exclusion Criteria:
    • neurological disorders, psychological disorders, dementia, Alzheimer's disease, end-organ failure conditions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Assiut Egypt 711111

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Waleed Gamal elddin, MD, Assiut university hospitals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Waleed Gamal Elddin Khaleel, Lecturer of Chest diseases and tuberculosis, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05293561
    Other Study ID Numbers:
    • WGEK-NCG
    First Posted:
    Mar 24, 2022
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Waleed Gamal Elddin Khaleel, Lecturer of Chest diseases and tuberculosis, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 24, 2022