Covid19NCT04881305
Characterizing Long-term Cognitive and Emotional Impairment in Post-COVID-19 Sequelae
An observational study of Covid19 and Post-COVID / Long-COVID, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Weeks and months after they have seemingly recovered from COVID-19, many patients continue to suffer from major long-term effects. While the virus typically hits the respiratory system, accumulating evidence now indicates a variety of other, non-respiratory symptoms, some of which manifest long after recovery from the… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Covid19, Post-COVID / Long-COVID
- What is being tested?
- questionnaires and neuropsychological assessment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2021to 1 Dec 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19
Who may be able to join
- Symptomatic individuals who recovered from COVID-19, 3-8 months after the onset of the acute stage of the disease. All individuals will be Israeli citizens, fluent Hebrew speakers with normal/corrected to normal vision and hearing abilities.
Who cannot join
- Asymptomatic convalescents, and symptomatic convalescents who have a history of one or more of the following: Chronic obstructive pulmonary disease (COPD), Congestive heart failure (CHF), ischemic heart disease (IHD), Cerebrovascular accident (CVA), Chronic Kidney disease (CKD) with glomerular filtration rate of less than 30ml/minute, Cirrhosis of the liver, Hypoxia (less than 80% oxygen levels at room air), neurologic disease, diagnosed decline in cognitive function prior to disease onset , psychiatric disease or usage of anti-psychotic medications, addiction to drugs or alcohol.
- In addition, a potential participant will be excluded from participation if he/she has a contraindication to magnetic resonance (MR) scanning, as defined by the Rabin Medical Center regulations: this includes patients with unremovable non-MR compatible implants, pregnant women and participants who suffer from claustrophobia.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 49100
Ili Margalit, MD, MPH, 0524510093
Ili Margalit, MD, MPH
About this study
Weeks and months after they have seemingly recovered from COVID-19, many patients continue to suffer from major long-term effects. While the virus typically hits the respiratory system, accumulating evidence now indicates a variety of other, non-respiratory symptoms, some of which manifest long after recovery from the acute phase of the disease. Neurologically-related symptoms among COVID-19 convalescents include extreme fatigue, headaches, sleep and mood disorders, cognitive decline and long-lasting impairments in the gustatory and olfactory systems. Interestingly, it seems that there is no direct link between the severity of the disease in its acute stage and the existence or the severity of the long-lasting symptoms. This means that to date, the possibility that even patients who present mild to moderate symptoms will still go on to develop long-lasting neuropsychiatric disorders following the disease cannot be ruled out. Unfortunately, most of the scientific literature relies on self-report of recovered patients and on qualitative assessments of healthcare workers. The literature still lacks a quantified objective characterization of these long-term impairments. Such data ought to be collected using designated questionnaires and validated neuropsychological assessments.
In order to allow for a better understanding of the biological mechanisms that underlie long-term effects of COVID-19, comprehensive research in this population is required. Alongside the identification of the variety of symptoms involved, the importance of an interdisciplinary approach that will take into account the emotional and cognitive aspects of the patients is necessary. Patients need accurate information about the possible consequences of this disease, in order to reduce their anxiety and, if needed, to allow them and their family members and caretakers to prepare for the comings. A systematic characterization of the mental effects of COVID-19 will allow global healthcare systems to develop prevention and rehabilitation programs and provide psychological and/or psychiatric follow-up and intervention programs, according to circumstances. By elucidating the mechanisms underlying emotional and cognitive deficits in COVID-19 convalescents, this study may improve future management of the consequences of the pandemic, potentially contributing to the development of efficient medical treatments for populations who suffer from the long-term effects of the disease.
Read the detailed description
70 participants (above 18 years of age) will be recruited from the post-COVID recovery clinic at the Beilinson Hospital, in the Rabin Medical Center (RMC). Only patients previously diagnosed using reverse transcription-polymerase chain reaction (RT-PCR), and that had no neurological or psychiatric disease prior to the COVID-19 episode, will be included. To avoid the risk of measuring adverse effects of lack of oxygen and/or artificial respiration procedures, COVID-19 patients who suffered from severe acute disease (according to World Health Organization criteria) will be excluded from participation. All potential participants will be given a detailed explanation about the research goals and procedure and they will all be asked to sign an institutional review board (IRB) consent form. Two groups, matched for age (5± years), will be examined: 35 case study patients: convalescents who report suffering from cognitive/emotional decline after recovering from COVID-19, and 35 control cases: convalescents with no cognitive/emotional complaints Participants will undergo: (1) An evaluation of COVID-19-related symptoms such as fatigue, post-exertional malaise, dizziness, etc. (2) A comprehensive evaluation of behavioral measures (e.g., hearing, vision, olfaction, sleep, social engagement) (3) A short validated neuropsychological evaluation, of multiple cognitive domains, with an emphasis on the memory domain; motivational factors will also be taken into account using performance validity tests (4) A thorough well-being and emotional state assessment, including the evaluation of mood disturbance and quality of life. The assessment will involve both self-report and cognitive tasks, previously associated with psychopathology. By recruiting a heterogeneous cohort in terms of symptom severity, the investigators will be able to test possible correlations between the emotional and cognitive impairments. In addition to the above-mentioned evaluations, a subgroup of participants will undergo either magnetic resonance imaging (MRI) or fluorodeoxyglucose (FDG)-positron emission tomography (PET)-computed tomography (CT), with the aim of clarifying the neural mechanisms underlying the neurologically-related symptoms.
- Conditions
- Covid19, Post-COVID / Long-COVID
- Being tested
- questionnaires and neuropsychological assessment
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires and neuropsychological assessmentDiagnostic test
Participants will undergo: (1) An evaluation of COVID-19-related symptoms such as fatigue, post-exertional malaise, dizziness, etc. (2) A comprehensive evaluation of behavioral measures (e.g., hearing, vision, olfaction, sleep, social engagement) (3) A short validated neuropsychological evaluation, of multiple cognitive domains, with an emphasis on the memory domain; motivational factors will also be taken into account using performance validity tests (4) A thorough well-being and emotional state assessment, including the evaluation of mood disturbance and quality of life. The assessment will involve both self-report and cognitive tasks, previously associated with psychopathology. In addition to the above-mentioned evaluations, a subgroup of participants will undergo either MRI examination or FDG PET-CT, with the aim of clarifying the neural mechanisms underlying the neurologically-related symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Adults recovered from COVID-19 (diagnosed using RT-PCR), 3-8 months after the onset of the acute stage of the disease, with cognitive/emotional complaints. Receives: Diagnostic Test: questionnaires and neuropsychological assessment | |
| Controls | Adults recovered from COVID-19 (diagnosed using RT-PCR), 3-8 months after the onset of the acute stage of the disease, reporting no cognitive/emotional complaints. Receives: Diagnostic Test: questionnaires and neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive/emotional impairment
abnormal outcome in the neuropsychological assessment
Measured: at time of testing (3 - 8 months after diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 May 2021
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881305
- Sponsor's protocol ID
- RMC-0939-20
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 11 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Long-term Cognitive and Emotional Impairment in Post-COVID-19 Sequelae
- ClinicalTrials.gov ID
- NCT04881305
- Acronym / sponsor ID
- RMC-0939-20
- Conditions
- Covid19, Post-COVID / Long-COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 11 May 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.
Weeks and months after they have seemingly recovered from COVID-19, many patients continue to suffer from major long-term effects. While the virus typically hits the respiratory system, accumulating evidence now indicates a variety of other, non-respiratory symptoms, some of which manifest long after recovery from the acute phase of the disease. Neurologically-related symptoms among COVID-19 convalescents include extreme fatigue, headaches, sleep and mood disorders, cognitive decline and long-lasting impairments in the gustatory and olfactory systems. Interestingly, it seems that there is no direct link between the severity of the disease in its acute stage and the existence or the severity of the long-lasting symptoms. This means that to date, the possibility that even patients who present mild to moderate symptoms will still go on to develop long-lasting neuropsychiatric disorders following the disease cannot be ruled out. Unfortunately, most of the scientific literature relies on self-report of recovered patients and on qualitative assessments of healthcare workers. The literature still lacks a quantified objective characterization of these long-term impairments. Such data ought to be collected using designated questionnaires and validated neuropsychological assessments.
In order to allow for a better understanding of the biological mechanisms that underlie long-term effects of COVID-19, comprehensive research in this population is required. Alongside the identification of the variety of symptoms involved, the importance of an interdisciplinary approach that will take into account the emotional and cognitive aspects of the patients is necessary. Patients need accurate information about the possible consequences of this disease, in order to reduce their anxiety and, if needed, to allow them and their family members and caretakers to prepare for the comings. A systematic characterization of the mental effects of COVID-19 will allow global healthcare systems to develop prevention and rehabilitation programs and provide psychological and/or psychiatric follow-up and intervention programs, according to circumstances. By elucidating the mechanisms underlying emotional and cognitive deficits in COVID-19 convalescents, this study may improve future management of the consequences of the pandemic, potentially contributing to the development of efficient medical treatments for populations who suffer from the long-term effects of the disease.
Detailed description
70 participants (above 18 years of age) will be recruited from the post-COVID recovery clinic at the Beilinson Hospital, in the Rabin Medical Center (RMC). Only patients previously diagnosed using reverse transcription-polymerase chain reaction (RT-PCR), and that had no neurological or psychiatric disease prior to the COVID-19 episode, will be included. To avoid the risk of measuring adverse effects of lack of oxygen and/or artificial respiration procedures, COVID-19 patients who suffered from severe acute disease (according to World Health Organization criteria) will be excluded from participation. All potential participants will be given a detailed explanation about the research goals and procedure and they will all be asked to sign an institutional review board (IRB) consent form. Two groups, matched for age (5± years), will be examined: 35 case study patients: convalescents who report suffering from cognitive/emotional decline after recovering from COVID-19, and 35 control cases: convalescents with no cognitive/emotional complaints Participants will undergo: (1) An evaluation of COVID-19-related symptoms such as fatigue, post-exertional malaise, dizziness, etc. (2) A comprehensive evaluation of behavioral measures (e.g., hearing, vision, olfaction, sleep, social engagement) (3) A short validated neuropsychological evaluation, of multiple cognitive domains, with an emphasis on the memory domain; motivational factors will also be taken into account using performance validity tests (4) A thorough well-being and emotional state assessment, including the evaluation of mood disturbance and quality of life. The assessment will involve both self-report and cognitive tasks, previously associated with psychopathology. By recruiting a heterogeneous cohort in terms of symptom severity, the investigators will be able to test possible correlations between the emotional and cognitive impairments. In addition to the above-mentioned evaluations, a subgroup of participants will undergo either magnetic resonance imaging (MRI) or fluorodeoxyglucose (FDG)-positron emission tomography (PET)-computed tomography (CT), with the aim of clarifying the neural mechanisms underlying the neurologically-related symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: questionnaires and neuropsychological assessmentAdults recovered from COVID-19 (diagnosed using RT-PCR), 3-8 months after the onset of the acute stage of the disease, with cognitive/emotional complaints. |
| Controls | – | Diagnostic Test: questionnaires and neuropsychological assessmentAdults recovered from COVID-19 (diagnosed using RT-PCR), 3-8 months after the onset of the acute stage of the disease, reporting no cognitive/emotional complaints. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19
Key inclusion criteria (1 listed)
- Symptomatic individuals who recovered from COVID-19, 3-8 months after the onset of the acute stage of the disease. All individuals will be Israeli citizens, fluent Hebrew speakers with normal/corrected to normal vision and hearing abilities.
Key exclusion criteria (2 listed)
- Asymptomatic convalescents, and symptomatic convalescents who have a history of one or more of the following: Chronic obstructive pulmonary disease (COPD), Congestive heart failure (CHF), ischemic heart disease (IHD), Cerebrovascular accident (CVA), Chronic Kidney disease (CKD) with glomerular filtration rate of less than 30ml/minute, Cirrhosis of the liver, Hypoxia (less than 80% oxygen levels at room air), neurologic disease, diagnosed decline in cognitive function prior to disease onset , psychiatric disease or usage of anti-psychotic medications, addiction to drugs or alcohol.
- In addition, a potential participant will be excluded from participation if he/she has a contraindication to magnetic resonance (MR) scanning, as defined by the Rabin Medical Center regulations: this includes patients with unremovable non-MR compatible implants, pregnant women and participants who suffer from claustrophobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaires and neuropsychological assessmentParticipants will undergo: (1) An evaluation of COVID-19-related symptoms such as fatigue, post-exertional malaise, dizziness, etc. (2) A comprehensive evaluation of behavioral measures (e.g., hearing, vision, olfaction, sleep, social engagement) (3) A short validated neuropsychological evaluation, of multiple cognitive domains, with an emphasis on the memory domain; motivational factors will also be taken into account using performance validity tests (4) A thorough well-being and emotional state assessment, including the evaluation of mood disturbance and quality of life. The assessment will involve both self-report and cognitive tasks, previously associated with psychopathology. In addition to the above-mentioned evaluations, a subgroup of participants will undergo either MRI examination or FDG PET-CT, with the aim of clarifying the neural mechanisms underlying the neurologically-related symptoms. | Diagnostic test | Cases, Controls |
Primary outcome
cognitive/emotional impairment
Time frame: at time of testing (3 - 8 months after diagnosis)
abnormal outcome in the neuropsychological assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
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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.
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 Covid19 and Post-COVID / Long-COVID, run by Rabin Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 11 May 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irit Shapira-Lichter, Dr (+97239376567, iritsh7@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive/emotional impairment (time frame: at time of testing (3 - 8 months after diagnosis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2021.