COVID-19NCT05143320
Cognitive, Emotional and Behavioural Impairments in Patients After Sars-Cov2 Infection
An observational study of COVID-19 and Sars-CoV-2 Infection, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Sars-CoV-2 Infection
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2021to 29 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Positive PCR from nasopharyngeal swab
- No ICU admission
Who cannot join
- Diagnosis of neurologic or psychiatric disorders;
- Previous cognitive impairment;
- Other medical conditions negatively affecting the cognitive status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19, Sars-CoV-2 Infection
- Keywords
- Covid-19, Cognition, Teleneuropsychology, Memory, Executive Functions
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Covid+ | Not described | |
| Covid- | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive and neuropsychiatirc symptoms in Covid-19 patients
Prevalence of neuropsychological and neuropsychiatric impairment in patients after hospitalization in patients with Sars-Cov2 infection.
Measured: About 20 days after hospital dismission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start8 Jan 2021
- Primary completion21 May 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143320
- Sponsor's protocol ID
- NPS impairment in Covid-19
- Status last verified
- Dec 2021
- First submitted
- 2 Dec 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Neuropsychiatric Features of COVID-19 Patients After Hospital Dismission: an Italian Sample.
- ClinicalTrials.gov ID
- NCT05143320
- Acronym / sponsor ID
- NPS impairment in Covid-19
- Conditions
- COVID-19, Sars-CoV-2 Infection
- Keywords
- Covid-19, Cognition, Teleneuropsychology, Memory, Executive Functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid+ | – | – |
| Covid- | – | – |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Positive PCR from nasopharyngeal swab
- No ICU admission
Key exclusion criteria (3 listed)
- Diagnosis of neurologic or psychiatric disorders;
- Previous cognitive impairment;
- Other medical conditions negatively affecting the cognitive status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Derived from this study: PubMed 35686079Cian 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.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Sars-CoV-2 Infection, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive and neuropsychiatirc symptoms in Covid-19 patients (time frame: About 20 days after hospital dismission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05143320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.