N/A N=2,598

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

HIV-1-infection · COVID-19

Bottom Line

View on ClinicalTrials.gov: NCT05481216 ↗

Enrolled (actual)

2,598

Serious AEs

28.6%

Results posted

Mar 2025

Primary outcome: Primary: 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 — 66; 67 Events

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: COVID-19 (Other); HIV-1 infection (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NEAT ID Foundation
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	66; 67	—
PRIMARY Kaplan-Meier Estimate of Primary End Point	13.6; 6.1	—
PRIMARY Number of Palliative Discharge	1; 0	—
PRIMARY Mortality	24; 23	—
PRIMARY Number of Critical Care Admission Events	55; 58	—
PRIMARY HIV Viral Load	427; 888; 73; 104	0.009 sig
PRIMARY Time Since HIV Diagnosis	17.1; 18.3	0.033 sig
PRIMARY Chronic Obstructive Pulmonary Disease	36; 43	0.012 sig
PRIMARY CD4 Cell Count	630; 630	0.458
PRIMARY Chronic Kidney Disease	38; 32	<0.001 sig
PRIMARY Body Weight	80; 77	<0.001 sig
SECONDARY Number of Hospitalisation Events	200; 208	—
SECONDARY Length of Hospital Stay	11; 9	—
SECONDARY Length of Stay in ICU	18; 7	—
SECONDARY Ventilator-free Days (VFDs)	—	—
SECONDARY Extracorporeal Membrane Oxygenation (ECMO)	—	—
SECONDARY Need for Kidney Replacement Therapy	13; 6	—
SECONDARY Measurement of Total Comorbidity Burden	2.35; 0.99	—
SECONDARY Estimate Risk of 30-day Mortality After COVID-19 Infection	2.65; 2.00	—
SECONDARY Blood Cell Counts at COVID-19 Diagnosis	212.1; 237.2; 7.2; 7.4; 7.0; 8.3	—
SECONDARY Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis	42.0; 47.4; 55.2; 54.0; 357.5; 412.2	—
SECONDARY Inflammatory Markers and Kidney Function Tests	0.7; 0.7; 52.6; 39.7; 1.8; 1.1	—
SECONDARY Biological Parameters at COVID-19 Diagnosis	1653.8; 1561.9; 1039.5; 1113.0	—
SECONDARY Cholesterol, Triglyceride and Glucose Levels	4.4; 3.8; 1.6; 1.9; 7.0; 7.4	—
SECONDARY Red Blood Cell Count	4.4; 4.6	—
SECONDARY Haemoglobin Levels	13.0; 13.1	—
SECONDARY Haematocrit	2.8; 2.8	—
SECONDARY MCV Levels	91.4; 87.3	—
SECONDARY MCH Levels	30.2; 29.1	—
SECONDARY HbA1C Levels	60.5; 99.2	—
SECONDARY C-reactive Protein Levels	12.6; 13.6	—

Summary

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.

Eligibility Criteria

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)
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05481216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.