Cognitive ImpairmentNCT05293561
Cognitive Impact in Patients With COVID-19 Infection
An observational study of Cognitive Impairment and COVID-19 Respiratory Infection, run by Assiut University at 1 site in Egypt.
Trial summary
SARS-COV-2 (severe acute respiratory syndrome- corona virus - 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment, COVID-19 Respiratory Infection
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Dec 2022
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: COVID-19 patients diagnosed using Real Time-Polymerase Chain Reaction to confirm the diagnosis and healthy control belonging to either gender. COVID-19 patients recruited from home isolation at first visit in outpatient clinic and then after end of isolation period for 14 days, patients included from hospital isolation ward; also recruited from the respiratory isolation ICU, chest department of Assiut university hospital.
Who may be able to join
- COVID-19 patients diagnosed using Real Time-Polymerase Chain Reaction to confirm the diagnosis
Who cannot join
- neurological disorders, psychological disorders, dementia, Alzheimer's disease, end-organ failure conditions
Trial locations and contacts
1 site in 1 country.
About this study
SARS-COV-2 (severe acute respiratory syndrome- corona virus - 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.
Read the 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).
- Keywords
- COVID-19; Cognitive Impairment; Anxiety; Depression
- Medical subject headings
- Cognitive Dysfunction, COVID-19, Anxiety Disorders, Depression
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-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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive impairment
degree of affection in cognition due to COVID-19 infection
Measured: 1 month
Secondary outcomes (1)
Level of Anxiety and depression among COVID-19 cases
Level of Anxiety and depression among COVID-19 cases
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Jun 2021
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Gamal Elddin Khaleel, Assiut University
- Investigators
- Waleed Gamal elddin, MD, Principal investigator, Assiut university hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293561
- Sponsor's protocol ID
- WGEK-NCG
- Status last verified
- Jan 2024
- First submitted
- 22 Mar 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alemanno F, Houdayer E, Parma A, Spina A, Del Forno A, Scatolini A, Angelone S, Brugliera L, Tettamanti A, Beretta L, Iannaccone S. COVID-19 cognitive deficits after respiratory assistance in the subacute phase: A COVID-rehabilitation unit experience. PLoS One. 2021 Feb 8;16(2):e0246590. doi: 10.1371/journal.pone.0246590. eCollection 2021.
PubMed 33556127Germani A, Buratta L, Delvecchio E, Gizzi G, Mazzeschi C. Anxiety Severity, Perceived Risk of COVID-19 and Individual Functioning in Emerging Adults Facing the Pandemic. Front Psychol. 2020 Dec 7;11:567505. doi: 10.3389/fpsyg.2020.567505. eCollection 2020.
PubMed 33364996
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impact in Patients With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT05293561
- Acronym / sponsor ID
- WGEK-NCG
- Keywords
- COVID-19; Cognitive Impairment; Anxiety; Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 24 Mar 2022 (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.
SARS-COV-2 (severe acute respiratory syndrome- corona virus - 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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients diagnosed using Real Time-Polymerase Chain Reaction to confirm the diagnosis and healthy control belonging to either gender. COVID-19 patients recruited from home isolation at first visit in outpatient clinic and then after end of isolation period for 14 days, patients included from hospital isolation ward; also recruited from the respiratory isolation ICU, chest department of Assiut university hospital.
Key inclusion criteria (1 listed)
- COVID-19 patients diagnosed using Real Time-Polymerase Chain Reaction to confirm the diagnosis
Key exclusion criteria (1 listed)
- neurological disorders, psychological disorders, dementia, Alzheimer's disease, end-organ failure conditions
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 impairment
Time frame: 1 month
degree of affection in cognition due to COVID-19 infection
1 secondary outcome
Level of Anxiety and depression among COVID-19 cases
Time frame: 1 month
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 31 Jan 2024.
- Background: PubMed 33556127Alemanno F, Houdayer E, Parma A, Spina A, Del Forno A, Scatolini A, Angelone S, Brugliera L, Tettamanti A, Beretta L, Iannaccone S. COVID-19 cognitive deficits after respiratory assistance in the subacute phase: A COVID-rehabilitation unit experience. PLoS One. 2021 Feb 8;16(2):e0246590. doi: 10.1371/journal.pone.0246590. eCollection 2021.
- Background: PubMed 33364996Germani A, Buratta L, Delvecchio E, Gizzi G, Mazzeschi C. Anxiety Severity, Perceived Risk of COVID-19 and Individual Functioning in Emerging Adults Facing the Pandemic. Front Psychol. 2020 Dec 7;11:567505. doi: 10.3389/fpsyg.2020.567505. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Waleed Gamal elddin, MD principal investigator
Assiut university hospitals
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 Cognitive Impairment and COVID-19 Respiratory Infection, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 31 Jan 2024. 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 Egypt. 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 impairment (time frame: 1 month). 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 NCT05293561, which also lists 2 linked publications.
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 31 Jan 2024.