Differences in Immune Response Among HIV-1-infected Individuals With Previous or Current COVID-19 (CoVIHDis).
CoVIHDis
Differences in Susceptibility and Cytokine Profile, Specific CD4/CD8 T Cell Response, Toll Like Receptors (TLRs) and Killer Immunoglobulin-like Receptors (KIRs) Among HIV-1-infected Individuals With Previous or Current COVID-19
1 other identifier
observational
90
1 country
1
Brief Summary
People living with HIV could have different susceptibility and outcome to the SARS CoV-2 infection. The risk of SARS CoV-2 infection in this population could be no related to HIV infection, immunodepression or antiretroviral therapy, but to the different susceptibility as measured by ACE2 or CD26 receptors. Also, patients with HIV-1 infection could have different cytokine profile and cellular immune response after SARS-CoV-2 infection, leading to a differential outcome,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2020
CompletedFirst Posted
Study publicly available on registry
August 26, 2020
CompletedStudy Start
First participant enrolled
January 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedOctober 18, 2022
October 1, 2022
2 years
August 22, 2020
October 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in immune cellular response
Differences in cellular response to SARS-COV-2 peptides
3 months
Study Arms (2)
Cases
HIV-1 infected individuals with previous or current diagnosis of SARS-CoV-2 infection, defined as the presence of suggestive symptoms and a positive PCR from the nasopharyngeal swab.
Controls
HIV-1-infected individuals of the same age (range, 5 years) and sex, who not have been diagnosed of clinical (asymptomatic) or confirmed SARS CoV-2 infection, but were positive for IgG antibodies (controls group 1) or with no evidence of SARS-CoV-2 infection (no previous neither current symptoms, negative for IgM/IgG antibodies, controls group 2)
Interventions
* ACE2 and CD26 receptor study * Cytokine profile: Quantification of plasma cytokine levels * SARS-CoV-2 CD4/CD8 T cell response * TLR7/8 activation * KIR characterization
Eligibility Criteria
HIV infected patients in regular follow up
You may qualify if:
- adult (\>18 year-old), confirmed HIV-1-infection, and provide written informed consent, with previous SARS CoV-2 infection as demonstrated by clinical and a positive PCR (cases) or no previous compatible symptoms and no diagnosis of SARS-CoV-2 infection (controls, classified according to serological determination)
You may not qualify if:
- unable to provide a written informed consent.
- immunological alterations (chronic intake of corticoid or immunosuppresants)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Ramon y Cajal
Madrid, 28034, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose L Casado, PhD
Hospital Ramon y Cajal
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2020
First Posted
August 26, 2020
Study Start
January 10, 2021
Primary Completion
December 30, 2022
Study Completion
March 30, 2023
Last Updated
October 18, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share