Markers of Neurological Damage Post Covid-19 in PLWH

NCT05719025 | Unknown

• 1 other identifier: Neuro COV-HIV
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Hiv

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency of neurocognitive and muscular (strength and balance) impairment

  Through study completion, an average of 1 year

Study Arms (4)

HIV + COVID+

HIV + COVID -

HIV - COVID +

HIV- COVID-

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele Turro

Milan, 20127, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

COVID-19; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Paola Cinque, MD

CONTACT

+390226433160; cinque.paola@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: February 8, 2023
• Study Start: October 24, 2022
• Primary Completion: March 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)