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CompletedNCT05143320Updated Dec 3, 2021

Cognitive, Emotional and Behavioural Impairments in Patients After Sars-Cov2 Infection

An observational study in COVID-19 and Sars-CoV-2 Infection, sponsored by Ospedale Generale Di Zona Moriggia-Pelascini. Completed at 1 site in Italy. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-03.

Sponsored by Ospedale Generale Di Zona Moriggia-Pelascini · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
29
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • COVID-19
  • Sars-CoV-2 Infection

Keywords

  • Covid-19
  • Cognition
  • Teleneuropsychology
  • Memory
  • Executive Functions
03

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability 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.

Inclusion criteria

  • Positive PCR from nasopharyngeal swab
  • No ICU admission

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
29 participants (actual)
Patient registry
No

Groups and cohorts

  • Covid+
  • Covid-
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What researchers measure

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.

    Time frame: About 20 days after hospital dismission

06

Study locations

1 site
  • "Moriggia Pelascini" Hospital
    Gravedona, Como 22015, Italy
07

References and documents

Publications

  • 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. PubMed 35686079 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT05143320
Lead sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Responsible party
Sponsor
First posted
Dec 3, 2021
Start date
Jan 8, 2021
Primary completion
May 21, 2021
Completion
Oct 29, 2021
Last update
Dec 3, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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