Markers of Neurological Damage Post Covid-19 in PLWH | NCT05719025

Studies
Markers of Neurological Damage Post Covid-19 in PLWH

NCT05719025

Sponsor

Scientific Institute San Raffaele

Status

Unknown status

Last Update Posted

Feb 8, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

COVID-19
Hiv

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 24, 2022Actual

Primary Completion Date

Mar 2023Estimated

Completion Date

Oct 2023Estimated

First Submitted Date

Oct 18, 2022

First Submission Date that Met QC Criteria

Feb 7, 2023

First Posted Date

Feb 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2023

Last Update Posted Date

Feb 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

9 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Label	Type	Description	Intervention Names
HIV + COVID+
HIV + COVID -
HIV - COVID +
HIV- COVID-

ID	Term
D000086382	COVID-19
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections