Effects of COVID-19 on Endothelium in HIV-Positive Patients in Sub-Saharan Africa

NCT04709302 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 342

Last updated 2023-03-10

No results posted yet for this study

Summary

Background: Coronavirus disease 2019 (COVID-19) has affected almost every country in the world, especially in terms of health system capacity and economic burden. People from sub-Saharan Africa (SSA) often face interaction between human immunodeficiency virus (HIV) infection and non-communicable diseases such as cardiovascular disease. Role of HIV infection and anti-retroviral treatment (ART) in altered cardiovascular risk is questionable and there is still need to further carry out research in this field. However, thus far it is unclear, what impact the COVID-19 co-infection in people living with HIV (PLHIV), with or without therapy will have. The ENDOCOVID project aims to investigate whether and how HIV-infection in COVID-19 patients modulates the time course of the disease, alters cardiovascular risk, and changes vascular endothelial function and coagulation parameters/ thrombosis risk.

Methods: In this long-term study, cardiovascular research on PLHIV with or without ART with COVID-19 and HIV-negative with COVID-19 will be carried out via clinical and biochemical measurements for cardiovascular risk factors and biomarkers of cardiovascular disease (CVD). Vascular and endothelial function will be measured by brachial artery flow-mediated dilatation (FMD), carotid intima-media thickness (IMT) assessments, and retinal blood vessel analyses, along with vascular endothelial biomarkers and coagualation markers. The correlation between HIV-infection in COVID-19 PLHIV with or without ART and its role in enhancement of cardiovascular risk and endothelial dysfunction will be assessed. Potential changes in these endpoints by COVID-19 will be followed for 4 weeks across the three groups (PLHIVwith or without ART and HIV negatives).

Impact of project: The ENDOCOVID project aims to evaluate in the long-term the cardiovascular risk and vascular endothelial function in PLHIV thus revealing an important transitional cardiovascular phenotype in COVID-19.

Conditions

  • Covid19
  • Hiv
  • ART

Interventions

BIOLOGICAL

COVID-19

Patients diagnosed with a COVID-19 infection

BIOLOGICAL

HIV

Patients diagnosed HIV-positive

DRUG

ART

Patients on ART

Sponsors & Collaborators

  • University of Olso

    collaborator UNKNOWN
  • Kristiania University College

    collaborator OTHER
  • Walter Sisulu University

    collaborator OTHER
  • Lagos State University

    collaborator OTHER
  • Management Sciences for Health

    collaborator OTHER
  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Nandu Goswami, Dr PhD · Medical University of Graz

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2024-06-30
Completion
2025-12-31

Countries

  • Nigeria
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04709302 on ClinicalTrials.gov