Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04881305 |
| Other study ID # |
RMC-0939-20 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
December 1, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Rabin Medical Center |
| Contact |
Irit Shapira-Lichter, Dr |
| Phone |
+97239376567 |
| Email |
iritsh7[@]clalit.org.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
