Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05220241 |
Other study ID # |
MVT_2021_26 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2022 |
Est. completion date |
July 1, 2024 |
Study information
Verified date |
October 2023 |
Source |
Fondation Ophtalmologique Adolphe de Rothschild |
Contact |
Amélie Yavchitz, MD, PhD |
Phone |
0033148036454 |
Email |
ayavchitz[@]for.paris |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
NEUROCOVID is a prospective multicenter study comparing the proportion of patients with
SARS-CoV-2 viral RNA at the level of the olfactory clefts in a group of cases compared to a
group of controls as well as the correlations between the virological and cellular
abnormalities observed in the olfactory mucosa and the severity of the clinical neurological
profile
Description:
More than 15% of people who developed COVID-19 would still have at least one symptom six
months older. In France, this would concern several hundred thousand people. The societal
consequences are important. The symptoms are very polymorphic; they evolve in a fluctuating
fashion and persist for several months. Neurological symptoms are often in the foreground and
include different symptoms, among which:
- Cognitive disorders (psychic slowing down, lack of clarity in thought, difficulty in
remembering certain facts, difficulty in performing double tasks, difficulty in finding
words).
- Sensory disturbances such as burning or tingling with or without root topography,
dizziness.
- Neurovegetative manifestations: sudden tachycardia, palpitations, vasomotor disorders,
excessive sweating, digestive disorders or post prandial malaise, feelings of malaise
(lipothymia with or without hypotension), dyspnea or a feeling of dyspnea, urinary
disorders
- Sleep disorders (insomnia, sleep fragmentation, nightmares or hypersomnia)
- Tension type headaches.
The mechanisms explaining the occurrence of these symptoms are still debated. An important
result is the recent demonstration by the UK's National Statistics Office that people with
"long COVID" may, for some, remain carriers of the SARS-CoV-2 virus for several months. So
far, viral persistence has only been demonstrated in a few specific cases of
immunocompromised people, almost all of them having been hospitalized.
Recently, in a pilot study conducted jointly by the Institut Pasteur and AP-HP, we
demonstrated that viral RNA could be found in immunocompetent patients with prolonged
neurological symptoms after COVID-19 (Melo et al 2021). This study concerned 4 patients
explored by micro-brushing the mucous membrane of the olfactory cracks under local anesthesia
more than 4 months after the initial COVID-19. In all patients, SARS-CoV-2 RNA persisted in
significant amounts.
Although this demonstration currently only concerns a small number of people, this study
provides evidence that the virus can remain hidden in the olfactory cracks (a tissue that is
part of the nervous system), including in people with PCR nasopharyngeal and / or SARS-CoV-2
serology become negative. This persistence of the virus after a so-called "acute" infection
is not unique. In EBOLA virus disease, some people have been shown to keep the virus in their
semen for several months.
It is now necessary to determine whether this persistence is specific to long COVID, what are
the mechanisms and the consequences of this persistence of the virus.
One of the hypotheses is that the virus would persist in endothelial cells and / or support
cells. Intermittent reactivation of the virus would lead to intermittent inflammation,
secretion of pro-inflammatory cytokines, activation of coagulation and innate immunity cells
(monocytes, mast cells, astrocytes, cerebral glial cells) or adaptive This activation could
be due to origin of possible micro-thrombosis responsible for a decrease in the oxygen supply
in the tissues. This tissue hypoxia could cause the intermittent "brain fog" complained about
by patients and the cerebral hypo-metabolisms seen on CT scans. The virus could infect other
cells as well, and the issue of direct infection of neurons remains unresolved.
In this study, we want to assess whether viral persistence is specific to patients with
prolonged symptoms following COVID-19, to assess whether the presence of SARS-CoV-2 RNA is
correlated with the ability of the virus to replicate, study the cellular abnormalities
associated with the presence of viruses, and correlate the observed cellular and virological
abnormalities with the clinical profile of patients.
We are interested in central neurological disorders, in particular cognitive disorders,
because they are often in the foreground, and they are by far the most disabling symptoms for
patients.