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

NEAT ID Foundation

Status: Completed

Conditions: COVID-19; HIV-1-infection

Treatments: Other: HIV-1 infection; Other: COVID-19

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05481216

303CoCo

Details and patient eligibility

About

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.

Enrollment: 2,598 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• • Cases (PLWHIV + COVID-19)

  1. Any gender

  2. At least 18 years of age

  3. Documented HIV-1 infection

  4. 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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  1. Any gender
  2. At least 18 years of age
  3. No documented HIV-1 infection
  4. 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
  5. 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)

  1. Any gender
  2. At least 18 years of age
  3. Documented HIV-1 infection
  4. No evidence of SARS-CoV-2 infection
  5. 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

Trial design

2,598 participants in 3 patient groups

PLWHIV with COVID-19 cases

Description:

Patients who are at least 18 years of age with documented HIV-1 infection and 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.

Treatment:

Other: HIV-1 infection

Other: COVID-19

PLWHIV without COVID-19 controls

Description:

Patients at least 18 years of age with documented HIV-1 infection.

Treatment:

Other: HIV-1 infection

HIV seronegative patients with COVID-19 controls

Description:

Patients at least 18 years of age with 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.

Treatment:

Other: COVID-19