Markers of Neurological Damage Post Covid-19 in PLWH (NeuroCOV-HIV)

Markers of Neurological Damage Post Covid-19 in People Living With HIV (PLWH)

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Hiv

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Paola Cinque, MD; Phone Number: +390226433160; Email: cinque.paola@hsr.it

Study Locations

• Italy
  • Milano, Italy, 20127
    • Recruiting
    • IRCCS Ospedale San Raffaele Turro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
HIV + COVID+
HIV + COVID -
HIV - COVID +
HIV- COVID-

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on neurological damage of COVID-19 in PLWH	Assessing the impact of COVID-19 in PLWH concerning the neurological damage, by measuring blood's markers like the Neurofilament Light Protein (NfL) and the Glial Fibrillary Acidic Protein (gFAP)	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of neurocognitive and muscular (strength and balance) impairment	Assessing the prevalence of: neurocognitive impairment, altered muscular function (strenght and balance), plasmatic level of Ubiquitin Carboxy-terminal Hydrolase L1 Neurons (UCH-L1) and total-tau, soluble and cellular infiammation's markers in blood and the expression profile of messenger ribonucleic acid (mRNA) in lymphocytes and the humoral and cellular answer against Sars-CoV2 in people living with HIV which had and ad not contract COVID-19	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Scientific Institute San Raffaele

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 24, 2022
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Wounds and Injuries; COVID-19; Trauma, Nervous System
• Other Study ID Numbers: Neuro COV-HIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No