NCT05143320

Brief Summary

Recent studies suggest cognitive, emotional and behavioural impairments occur in patients after SARS-CoV-2 infection. Problems with memory, attention, information processing and executive functions are particularly prevalent in these patients, probably due to hypothesised sensitivity of the hippocampus to the virus. Cognitive impairment is also present in patients with no neurological, neuropsychological and neuropsychiatric history. Therefore, the aim of the present study is to describe neuropsychological and neuropsychiatric features in patients recovered from moderate to severe forms of Covid-19 some weeks after hospital dismission.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
Last Updated

December 3, 2021

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

December 2, 2021

Last Update Submit

December 2, 2021

Conditions

Keywords

Covid-19CognitionTeleneuropsychologyMemoryExecutive Functions

Outcome Measures

Primary Outcomes (1)

  • Cognitive and neuropsychiatirc symptoms in Covid-19 patients

    Prevalence of neuropsychological and neuropsychiatric impairment in patients after hospitalization in patients with Sars-Cov2 infection.

    About 20 days after hospital dismission

Study Arms (2)

Covid+

Covid-

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who were hospitalized in the Covid ward and recovered from the acute phase of Covid-19 with no need of ICU admission. All patients had SARS-Cov-2 infection confirmed by positive PCR from nasopharyngeal swab. Neuropsychological study was performed on average 20 days after hospital discharge to have the most recent possible cognitive profile related to the infection. We enrolled 29 healthy controls (Covid-) who did not have SARS COV 2 infections with a 1:1 match by age, education and gender.

You may qualify if:

  • Positive PCR from nasopharyngeal swab
  • No ICU admission

You may not qualify if:

  • Diagnosis of neurologic or psychiatric disorders;
  • Previous cognitive impairment;
  • Other medical conditions negatively affecting the cognitive status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Moriggia Pelascini" Hospital

Gravedona, Como, 22015, Italy

Location

Related Publications (1)

  • Cian V, De Laurenzis A, Siri C, Gusmeroli A, Canesi M. Cognitive and Neuropsychiatric Features of COVID-19 Patients After Hospital Dismission: An Italian Sample. Front Psychol. 2022 May 24;13:908363. doi: 10.3389/fpsyg.2022.908363. eCollection 2022.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 3, 2021

Study Start

January 8, 2021

Primary Completion

May 21, 2021

Study Completion

October 29, 2021

Last Updated

December 3, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations