Clinical trial NCT05719025: Markers of Neurological Damage Post Covid-19 in PLWH
Official title: Markers of Neurological Damage Post Covid-19 in People Living With HIV (PLWH)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Hiv
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * HIV+ COVID+: people living with HIV that get corona virus disease 19 (COVID19) diagnosed at least 9 month ago with a positive rino-pharingeal swab (molecular or antigenic), or with compatible clinic and a positive sierologic test for Sars-CoV2 before the vaccination; Age \> 50 years old, no gender.
* HIV+ COVID-: people living with HIV that had not get COVID19. Age\>50 years; no gender.
* HIV- COVID+: people without HIV that get COVID19 diagnosed at least 9 month ago with a positive rino-pharingeal swab (molecular or antigenic), or with compatible clinic and a positive sierologic test for Sars-CoV2 before the vaccination; Age \> 50 years old, no gender.
* HIV- COVID-: people without HIV that had not get COVID19 (healthy people and volunteers) Age\>50 years; no gender.

Brief summary: Both HIV infection and Covid-19 are associated to cognitive and psychiatric impairment, like anxiety and depression. These disturbs are well-known in HIV infection and partially characterized in Covid-19.

Detailed description: HIV has an high neurotropism and the HIV-associated dementia was one of the most frequent clinical complications and principal cause of death before the introduction of antiretroviral theraphy (ART). However, also in PLWH taking ART and with suppressed viral load over years, the proportion of neuro-cognitive impairment, anxiety and depression remain higher then the general population.

These problems may be the consequence of a persistent systemic and central nervous system (CNS) immuno-activation caused by the persistence of viral reservoir in the peripheric and tissutal lymphocytes.

Neurological and psychiatric problems have been described in a variable proportion in patients with corona virus disease 19 (COVID-19) and in the complex it doesn't seems to be the direct consequence of CNS cellular infection, but rather of inflammation and coagulations disorder due to COVID-19 in the nervous tissue.

Eligibility criteria: Inclusion Criteria:

* HIV+ COVID+: people living with HIV that get corona virus disease 19 (COVID19) diagnosed at least 9 month ago with a positive rino-pharyngeal swab (molecular or antigenic), or with compatible clinic and a positive serologic test for Sars-CoV2 before the vaccination; Age \> 50 years old, no gender.
* HIV+ COVID-: people living with HIV that had not get COVID19. Age\>50 years; no gender.
* HIV- COVID+: people without HIV that get COVID19 diagnosed at least 9 month ago with a positive rino-pharyngeal swab (molecular or antigenic), or with compatible clinic and a positive serologic test for Sars-CoV2 before the vaccination; Age \> 50 years old, no gender.
* HIV- COVID-: people without HIV that had not get COVID19 (healthy people and volunteers) Age\>50 years; no gender.

Exclusion Criteria:

* Inability to perform the neuro-cognitive or functional tests due to neurologic deficit (inability to writing, reading, understand how to perform the tests)

Primary outcomes:
measure: Impact on neurological damage of COVID-19 in PLWH
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Frequency of neurocognitive and muscular (strength and balance) impairment
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele Turro
Study officials:
References: