- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05143320
Cognitive, Emotional and Behavioural Impairments in Patients After Sars-Cov2 Infection
December 2, 2021 updated by: Ospedale Generale Di Zona Moriggia-Pelascini
Cognitive and Neuropsychiatric Features of COVID-19 Patients After Hospital Dismission: an Italian Sample.
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
29
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Como
-
Gravedona, Como, Italy, 22015
- "Moriggia Pelascini" Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Positive PCR from nasopharyngeal swab
- No ICU admission
Exclusion Criteria:
- Diagnosis of neurologic or psychiatric disorders;
- Previous cognitive impairment;
- Other medical conditions negatively affecting the cognitive status.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Covid+
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Covid-
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive and neuropsychiatirc symptoms in Covid-19 patients
Time Frame: About 20 days after hospital dismission
|
Prevalence of neuropsychological and neuropsychiatric impairment in patients after hospitalization in patients with Sars-Cov2 infection.
|
About 20 days after hospital dismission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2021
Primary Completion (Actual)
May 21, 2021
Study Completion (Actual)
October 29, 2021
Study Registration Dates
First Submitted
December 2, 2021
First Submitted That Met QC Criteria
December 2, 2021
First Posted (Actual)
December 3, 2021
Study Record Updates
Last Update Posted (Actual)
December 3, 2021
Last Update Submitted That Met QC Criteria
December 2, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NPS impairment in Covid-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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