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Completed

NCT Number: NCT05481216

HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV

HIV CoCo is a European multi-centre, multi-country, retrospective, observational case-control study that will aim to describe clinical outcomes and identify risk factors for People Living With HIV (PLWHIV) who are co-infected with the SARS-CoV-2 coronavirus.

The study will address two central questions:

1. Is there a particular risk for COVID-19 in PLWHIV as compared to HIV seronegative control COVID-19 cases? 2. Are there particular factors, within the group of PLWHIV, which put them at risk for a more severe COVID-19 disease course?

The study will address these questions by recruiting patients co-infected with both HIV and SARS-CoV-2 and comparing them to two control groups - one group infected with SARS-CoV-2 only and another group infected with HIV only. Only deidentified, real-world retrospective data will be used for the study, collected as part of standard, routine clinical care.

Additionally, this study will also look to:

1. Describe the differences in the clinical manifestation of COVID-19 in PLWHIV compared to HIV seronegative controls 2. Describe the response to treatment, including supportive care and novel therapies against COVID-19, including antiviral or immunomodulatory therapy 3. Describe the co-morbidities in PLWHIV and controls with COVID-19 4. Compare the severity of COVID-19 between PLWHIV and the COVID-19 only controls at diagnosis and hospital admission.

Data will be collected about patient outcomes from COVID-19 (including hospitalisation for COVID-19, length of stay in hospital, critical care admission, ventilation/oxygenation requirements, and need for kidney replacement therapy), as well as pre-existing health conditions, and relevant blood results at COVID-19 diagnosis.

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Key information

Conditions

HIV-1-infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint Pierre, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Cases (PLWHIV + COVID-19)
  • Any gender
  • At least 18 years of age
  • Documented HIV-1 infection
  • Confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021
  • Controls (COVID-19)

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  • Any gender
  • At least 18 years of age
  • No documented HIV-1 infection
  • Confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021
  • Meet the matching criteria

For comparing PLWHIV & COVID-19 versus HIV seronegative COVID-19 patients, a 1:1 matching will be performed according to the following criteria:

  • Age (+/- 5 years)
  • Sex
  • Ethnicity (where available)
  • Month of COVID-19 diagnosis (+/- 2 months)
  • COVID-19 diagnosis inpatient OR
  • COVID-19 diagnosis outpatient (ambulatory)
  • Controls (PLWHIV)
  • Any gender
  • At least 18 years of age
  • Documented HIV-1 infection
  • No evidence of SARS-CoV-2 infection
  • Meet the matching criteria

For comparing PLWHIV & COVID-19 versus PLWHIV without COVID-19, a 1:2 matching for similar risk of acquiring COVID-19 will be performed according to the following criteria:

  • Age (+/- 5 years)
  • Sex
  • Ethnicity (where available)

Exclusion criteria

For cases (PLWHIV + COVID-19) and for COVID-19 only controls:

  • COVID-19 diagnosed based on clinical criteria

Treatment and study plan

COVID-19

Other

Diagnosed with COVID-19 infection

HIV-1 infection

Other

Diagnosed with HIV-1 infection

Primary outcomes

  1. Number of Composite Primary End Point (Critical Care Admission, Palliative Discharge When Discharged From Hospital, or Mortality Within the 6 Weeks After Diagnosis of COVID-19) Events

    Time frame: From baseline (diagnosis of COVID-19) to Week 6

    The primary endpoint is a composite of the number of critical care admission (high dependency unit or intensive care unit), mortality in hospital or palliative discharge when discharged from hospital, or mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital (where applicable) events. Time-to-event methods, including Kaplan-Meier survival curves and Cox proportional-hazards models, will be used for this analysis. The time to the primary endpoints will be defined as:

    • For participants admitted to critical care Time = [Date of Critical care admission - Date of positive PCR test for COVID-19] + 1
    • For participants admitted to critical care before diagnosis of COVID-19, Time=1 day.
    • For participants with palliative discharge when discharged from hospital Time = [Date of discharge from hospital to palliative care - Date of positive PCR test for COVID-19] + 1.
    • For participants died Time = [Date of death - Date of positive PCR test for COVID-19] + 1.

  2. Kaplan-Meier Estimate of Primary End Point

    Time frame: From Baseline (diagnosis of COVID-19 ) to week 6

    Kaplan-Meier estimate of the composite number of critical care admission, palliative discharge and death events

  3. Number of Palliative Discharge

    Time frame: Baseline (diagnosis of COVID-19) to week 6

    Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events

  4. Mortality

    Time frame: Baseline (diagnosis of COVID-19) to week 6

    Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital

  5. Number of Critical Care Admission Events

    Time frame: Baseline (diagnosis of COVID-19) to week 6

    Number of admission events to a high dependency unit or intensive care unit

  6. HIV Viral Load

    Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

    Identification of risk factors for COVID-19 infection within the group of PLHIV: HIV viral load

  7. Time Since HIV Diagnosis

    Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

    Identification of risk factors for COVID-19 infection within the group of PLHIV: Time since HIV diagnosis

  8. Chronic Obstructive Pulmonary Disease

    Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

    Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Obstructive Pulmonary Disease

  9. CD4 Cell Count

    Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

    Identification of risk factors for COVID-19 infection within the group of PLHIV: CD4 cell count

  10. Chronic Kidney Disease

    Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

    Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Kidney Disease

  11. Body Weight

    Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)

    Identification of risk factors for COVID-19 infection within the group of PLHIV: Body weight

Secondary outcomes

  1. Number of Hospitalisation Events

    Time frame: Baseline (diagnosis of COVID-19) to week 6

    Number of hospital admission for COVID-19 events

  2. Length of Hospital Stay

    Time frame: Baseline (diagnosis of COVID-19) to week 6

    Length of stay in hospital following hospitalisation for COVID-19

  3. Length of Stay in ICU

    Time frame: Baseline (diagnosis of COVID-19) to week 6

    Median Length of Stay in Intensive Care Unit

  4. Ventilator-free Days (VFDs)

    Time frame: 6 weeks after diagnosis of COVID-19

    Number of ventilator-free days

  5. Extracorporeal Membrane Oxygenation (ECMO)

    Time frame: Baseline (diagnosis of COVID-19) to week 6

    Length of extracorporeal membrane oxygenation

  6. Need for Kidney Replacement Therapy

    Time frame: Baseline(diagnosis of COVID-19) to week 6

    The number of patients requiring kidney replacement therapy

  7. Measurement of Total Comorbidity Burden

    Time frame: 6 weeks after diagnosis of COVID-19

    Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Index consists of 19 conditions, each with an assigned weight from 1 to 6 according to the relative risk of dying. The total score is derived by summing up the weights of comorbid conditions presented. Based on the CCI score, the severity of comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5. The minimum score value is 0 and maximum is 37. A higher score means a more greater mortality risk.

  8. Estimate Risk of 30-day Mortality After COVID-19 Infection

    Time frame: Baseline (diagnosis of COVID-19) to week 6

    Estimate risk of 30-day mortality after COVID-19 infection using pre-COVID health status (estimated using the Veterans Health Administration COVID-19 (VACO) index). The VACO index is expressed as a percentage and calculated based on age, sex, Charlson comorbidity index (CCI), and the presence of myocardial infarction (MI) or peripheral vascular disease (PVD). The index range is from 0.2 to 48.0. A higher score means a greater risk of mortality.

  9. Blood Cell Counts at COVID-19 Diagnosis

    Time frame: Baseline (Diagnosis of COVID-19)

    The endpoint is the blood cell counts at COVID-19 diagnosis. The analyses will be performed with all PLHIV with COVID-19 and matched HIV-uninfected individual with COVID-19 who have data regarding the blood cell count of interest at COVID-19 diagnosis

  10. Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis

    Time frame: Baseline(COVID-19 diagnosis)

    The endpoint is the liver function (ALT, AST) and tissue damage (lactate dehydrogenase) parameters at COVID-19 diagnosis.

  11. Inflammatory Markers and Kidney Function Tests

    Time frame: Baseline (COVID-19 Diagnosis)

    Inflammatory markers and Kidney Function tests at COVID-19 diagnosis

  12. Biological Parameters at COVID-19 Diagnosis

    Time frame: Baseline(COVID-19 diagnosis)

    Biological parameters (D-dimer and Ferritin levels) at COVID-19 diagnosis

  13. Cholesterol, Triglyceride and Glucose Levels

    Time frame: Baseline(COVID-19 diagnosis)

    Cholesterol, Triglyceride and Glucose levels at COVID-19 diagnosis

  14. Red Blood Cell Count

    Time frame: Baseline(COVID-19 Diagnosis)

    Red blood cell (RBC) count at COVID-19 Diagnosis

  15. Haemoglobin Levels

    Time frame: Baseline(COVID-19 diagnosis)

    Haemoglobin levels at COVID-19 diagnosis

  16. Haematocrit

    Time frame: Baseline (COVID-19 diagnosis)

    Haematocrit levels at COVID-19 diagnosis

  17. MCV Levels

    Time frame: Baseline(COVID-19 diagnosis)

    Mean Corpuscular volume (MCV) levels at COVID-19 diagnosis

  18. MCH Levels

    Time frame: Baseline(COVID-19 diagnosis)

    Mean Corpuscular Haemoglobin levels at COVID-19 diagnosis

  19. HbA1C Levels

    Time frame: Baseline(COVID-19 diagnosis)

    Glycated Haemoglobin (HbA1C) levels at COVID-19 diagnosis

  20. C-reactive Protein Levels

    Time frame: Baseline(COVID-19 diagnosis)

    C-reactive protein levels at COVID-19 diagnosis

Sponsors and collaborators

Lead sponsor

NEAT ID Foundation

Other

Collaborators

  • Gilead Sciences

Registry information

Acronym: HIV CoCo

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2022
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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