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

NCT04709302 | Unknown DMC

• 1 other identifier: ENDOCOVID
• Study Type: observational
• Target: 342
• Locations: 2 countries
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (3)

• Number of patients developing Acute Respiratory Distress Syndrome

  Comparison of all three groups, recorded for each patient

  through study completion, up to 3 months

• Number of ICU admissions

  Comparison of all three groups, recorded for each patient

  through study completion, up to 3 months

• Number of Deaths

  Comparison of all three groups

  through study completion, up to 3 months

Secondary Outcomes (15)

• Cardiometabolic Status: ADMA

  through study completion, an average of 3 months

• Cardiometabolic Status: Cholesterol

  through study completion, an average of 3 months

• Cardiometabolic Status: Triglycerides

  through study completion, an average of 3 months

• Cardiometabolic Status: HDL cholesterol

  through study completion, an average of 3 months

• Cardiometabolic Status: LDL cholesterol

  through study completion, an average of 3 months

Study Arms (3)

COVID-19 positive, HIV-positive with ART

Patients tested positive for SARS-CoV-2 Patients tested positive for HIV who are on ART

Biological: COVID-19; Biological: HIV; Drug: ART

COVID-19 positive, HIV-positive without ART

Patients tested positive for SARS-CoV-2 Patients tested positive for HIV ART naive group

Biological: COVID-19; Biological: HIV

COVID-19 positive, HIV-negative

Patients tested positive for SARS-CoV-2 Patients tested positive for HIV ART naive group

Biological: COVID-19

Interventions

COVID-19 BIOLOGICAL

Patients diagnosed with a COVID-19 infection

Also known as: SARS-CoV-2 positive

COVID-19 positive, HIV-negative; COVID-19 positive, HIV-positive with ART; COVID-19 positive, HIV-positive without ART

HIV BIOLOGICAL

Patients diagnosed HIV-positive

COVID-19 positive, HIV-positive with ART; COVID-19 positive, HIV-positive without ART

ART DRUG

Patients on ART

COVID-19 positive, HIV-positive with ART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants of the ENDOCOVID study population are patients with COVID-19, who at the same time are infected with HIV (with or without ART), or are HIV negative. Some may be admitted in the ICU. For inclusion into the study, participants must be positive for SARS-CoV-2 RNA and 18 years or older. Participants will be excluded from the study if they are less than 3 months post-partum and those with other co-infections than HIV such as tuberculosis Participants fulfilling the criteria will be invited into the study and asked to provide written informed consent.

You may qualify if:

• PLHIV without antiretroviral therapy but with COVID-19 infection
• PLHIV with antiretroviral therapy and COVID-19 infection
• HIV-negative patients, sex- and age matched, infected with COVID-19;
• older than 18 years

You may not qualify if:

• Those with known co-infections such as hepatitis B and C
• with a viral load of HIV RNA \>1000 copies/ml under ART or with advanced symptoms of AIDS
• negative for SARS-CoV-2 RNA

Sponsors & Collaborators

• Medical University of Graz: lead
• University of Olso: collaborator
• Kristiania University College: collaborator
• Walter Sisulu University: collaborator
• Lagos State University: collaborator
• Management Sciences for Health: collaborator

Study Sites (3)

University of Ilorin Teaching Hospital

Ilorin, Kwara State, Nigeria

Location

Lagos Stae University Teaching Hospital Ikeja

Lagos, Nigeria

Location

Walter Sisulu University

Mthatha, South Africa

Location

Related Publications (1)

• Goswami N, Fredriksen PM, Lundin KEA, Agu C, Elias SO, Motaung KS, Brix B, Cvirn G, Sourij H, Stelzl E, Kessler HH, Salon A, Nkeh-Chungag B. COVID-19 and its effects on endothelium in HIV-positive patients in sub-Saharan Africa: Cardiometabolic risk, thrombosis and vascular function (ENDOCOVID STUDY). BMC Infect Dis. 2021 Jul 31;21(1):719. doi: 10.1186/s12879-021-06426-8.

  PMID: 34332551 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

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

Study Officials

• Nandu Goswami, Dr PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: February 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 10, 2023

Record last verified: 2023-03

Locations

NG (2); ZA (1)