COVID-19, HIV-1-infection
Conditions
Brief 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.
Interventions
OTHERCOVID-19
Diagnosed with COVID-19 infection
OTHERHIV-1 infection
Diagnosed with HIV-1 infection
Sponsors
Gilead Sciences
NEAT ID Foundation
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) <!-- --> 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Kaplan-Meier Estimate of Primary End Point | 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 |
| Number of Palliative Discharge | Baseline (diagnosis of COVID-19) to week 6 | Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events |
| Mortality | Baseline (diagnosis of COVID-19) to week 6 | Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital |
| Number of Critical Care Admission Events | Baseline (diagnosis of COVID-19) to week 6 | Number of admission events to a high dependency unit or intensive care unit |
| HIV Viral Load | 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 |
| Time Since HIV Diagnosis | 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 |
| Chronic Obstructive Pulmonary Disease | 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 |
| CD4 Cell Count | 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 |
| Chronic Kidney Disease | 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 |
| Body Weight | 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
| Measure | Time frame | Description |
|---|---|---|
| Biological Parameters at COVID-19 Diagnosis | Baseline(COVID-19 diagnosis) | Biological parameters (D-dimer and Ferritin levels) at COVID-19 diagnosis |
| Cholesterol, Triglyceride and Glucose Levels | Baseline(COVID-19 diagnosis) | Cholesterol, Triglyceride and Glucose levels at COVID-19 diagnosis |
| Red Blood Cell Count | Baseline(COVID-19 Diagnosis) | Red blood cell (RBC) count at COVID-19 Diagnosis |
| Haemoglobin Levels | Baseline(COVID-19 diagnosis) | Haemoglobin levels at COVID-19 diagnosis |
| Number of Hospitalisation Events | Baseline (diagnosis of COVID-19) to week 6 | Number of hospital admission for COVID-19 events |
| MCV Levels | Baseline(COVID-19 diagnosis) | Mean Corpuscular volume (MCV) levels at COVID-19 diagnosis |
| MCH Levels | Baseline(COVID-19 diagnosis) | Mean Corpuscular Haemoglobin levels at COVID-19 diagnosis |
| HbA1C Levels | Baseline(COVID-19 diagnosis) | Glycated Haemoglobin (HbA1C) levels at COVID-19 diagnosis |
| C-reactive Protein Levels | Baseline(COVID-19 diagnosis) | C-reactive protein levels at COVID-19 diagnosis |
| Haematocrit | Baseline (COVID-19 diagnosis) | Haematocrit levels at COVID-19 diagnosis |
| Length of Hospital Stay | Baseline (diagnosis of COVID-19) to week 6 | Length of stay in hospital following hospitalisation for COVID-19 |
| Length of Stay in ICU | Baseline (diagnosis of COVID-19) to week 6 | Median Length of Stay in Intensive Care Unit |
| Ventilator-free Days (VFDs) | 6 weeks after diagnosis of COVID-19 | Number of ventilator-free days |
| Extracorporeal Membrane Oxygenation (ECMO) | Baseline (diagnosis of COVID-19) to week 6 | Length of extracorporeal membrane oxygenation |
| Need for Kidney Replacement Therapy | Baseline(diagnosis of COVID-19) to week 6 | The number of patients requiring kidney replacement therapy |
| Measurement of Total Comorbidity Burden | 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. |
| Estimate Risk of 30-day Mortality After COVID-19 Infection | 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. |
| Blood Cell Counts at COVID-19 Diagnosis | 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 |
| Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis | Baseline(COVID-19 diagnosis) | The endpoint is the liver function (ALT, AST) and tissue damage (lactate dehydrogenase) parameters at COVID-19 diagnosis. |
| Inflammatory Markers and Kidney Function Tests | Baseline (COVID-19 Diagnosis) | Inflammatory markers and Kidney Function tests at COVID-19 diagnosis |
Countries
Belgium, France, Netherlands, Spain, United Kingdom
Participant flow
Recruitment details
PLWH were identified from European sites in the NEAT ID network. PLWH are routinely followed-up at specialized outpatient clinics with regular follow up visits as standard of care. HIV-COVID+ inpatient controls were from the same sites of the NEAT ID network. HIV-COVID-19+ outpatient controls were from the anonymized real-world primary care medical database THIN.
Pre-assignment details
PCR-confirmed SARS-CoV-2 infected PLWH (HIV+COVID+) were matched 1:1(outpatient) or 1:3(inpatient )against HIV negative PCR-confirmed COVID-19-infected individuals (HIV-COVID+) and 1:2 COVID-19 negative PLWH (HIV+COVID-).
Participants by arm
| Arm | Count |
|---|---|
| PLWHIV With COVID-19 Cases 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.
COVID-19: Diagnosed with COVID-19 infection
HIV-1 infection: Diagnosed with HIV-1 infection | 500 |
| PLWHIV Without COVID-19 Controls Patients at least 18 years of age with documented HIV-1 infection.
HIV-1 infection: Diagnosed with HIV-1 infection | 992 |
| HIV Seronegative Patients With COVID-19 Controls 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.
COVID-19: Diagnosed with COVID-19 infection | 1,106 |
| Total | 2,598 |
Baseline characteristics
| Characteristic | PLWHIV With COVID-19 Cases | HIV Seronegative Patients With COVID-19 Controls | PLWHIV Without COVID-19 Controls | Total |
|---|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 11.3 | 51 years STANDARD_DEVIATION 11.1 | 52 years STANDARD_DEVIATION 11.1 | 51.6 years STANDARD_DEVIATION 11.2 |
| Age, Customized Age (years) <60 years | 388 Participants | 878 Participants | 778 Participants | 2044 Participants |
| Age, Customized Age (years) ≥ 60 years | 112 Participants | 228 Participants | 214 Participants | 554 Participants |
| Blood cell counts at COVID-19 diagnosis Basophils | 0.05 10^9/L cells STANDARD_DEVIATION 0.17 | 0.04 10^9/L cells STANDARD_DEVIATION 0.16 | — | 0.05 10^9/L cells STANDARD_DEVIATION 0.16 |
| Blood cell counts at COVID-19 diagnosis Eosinophils | 0.07 10^9/L cells STANDARD_DEVIATION 0.12 | 0.13 10^9/L cells STANDARD_DEVIATION 0.59 | — | 0.10 10^9/L cells STANDARD_DEVIATION 0.42 |
| Blood cell counts at COVID-19 diagnosis Lymphocytes | 2.0 10^9/L cells STANDARD_DEVIATION 3.9 | 1.8 10^9/L cells STANDARD_DEVIATION 3.2 | — | 1.9 10^9/L cells STANDARD_DEVIATION 3.6 |
| Blood cell counts at COVID-19 diagnosis Monocytes | 1.0 10^9/L cells STANDARD_DEVIATION 3.3 | 0.7 10^9/L cells STANDARD_DEVIATION 1.1 | — | 0.8 10^9/L cells STANDARD_DEVIATION 2.5 |
| Blood cell counts at COVID-19 diagnosis Neutrophils | 7.0 10^9/L cells STANDARD_DEVIATION 11.9 | 8.3 10^9/L cells STANDARD_DEVIATION 14.3 | — | 7.7 10^9/L cells STANDARD_DEVIATION 13.2 |
| Blood cell counts at COVID-19 diagnosis Platelet count | 212 10^9/L cells STANDARD_DEVIATION 87.9 | 237 10^9/L cells STANDARD_DEVIATION 105.5 | — | 225 10^9/L cells STANDARD_DEVIATION 97.9 |
| Blood cell counts at COVID-19 diagnosis WBC count | 7.2 10^9/L cells STANDARD_DEVIATION 3.5 | 7.4 10^9/L cells STANDARD_DEVIATION 4.1 | — | 7.3 10^9/L cells STANDARD_DEVIATION 3.8 |
| Body Mass Index | 28.1 kg/m^2 STANDARD_DEVIATION 6 | 28.7 kg/m^2 STANDARD_DEVIATION 6.2 | 26.8 kg/m^2 STANDARD_DEVIATION 5.4 | 27.7 kg/m^2 STANDARD_DEVIATION 5.9 |
| Body weight | 82 kg STANDARD_DEVIATION 17.1 | 81 kg STANDARD_DEVIATION 19.1 | 79 kg STANDARD_DEVIATION 16.1 | 80.4 kg STANDARD_DEVIATION 17.6 |
| CD4 cell count | 654 cells/mm^3 STANDARD_DEVIATION 332.9 | — | 669 cells/mm^3 STANDARD_DEVIATION 321.9 | 664 cells/mm^3 STANDARD_DEVIATION 325.6 |
| Comorbidities Cerebrovascular Accident | 19 Participants | 24 Participants | 25 Participants | 68 Participants |
| Comorbidities Chronic Kidney Disease | 38 Participants | 14 Participants | 32 Participants | 84 Participants |
| Comorbidities Chronic Obstructive Pulmonary Disease | 36 Participants | 35 Participants | 43 Participants | 114 Participants |
| Comorbidities Congestive Heart Failure | 13 Participants | 21 Participants | 20 Participants | 54 Participants |
| Comorbidities Connective Tissue Disease | 21 Participants | 144 Participants | 25 Participants | 190 Participants |
| Comorbidities Current or history of Cancer | 46 Participants | 79 Participants | 99 Participants | 224 Participants |
| Comorbidities Dementia | 16 Participants | 6 Participants | 19 Participants | 41 Participants |
| Comorbidities Diabetes | 59 Participants | 131 Participants | 97 Participants | 287 Participants |
| Comorbidities Hemiplegia | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Comorbidities History of Pneumonia | 83 Participants | 46 Participants | 146 Participants | 275 Participants |
| Comorbidities Leukemia | 1 Participants | 3 Participants | 3 Participants | 7 Participants |
| Comorbidities Liver Disease | 69 Participants | 54 Participants | 141 Participants | 264 Participants |
| Comorbidities Lymphoma | 12 Participants | 10 Participants | 30 Participants | 52 Participants |
| Comorbidities Myocardial Infarction | 16 Participants | 17 Participants | 34 Participants | 67 Participants |
| Comorbidities Paralysis of Arm(s) or Leg(s) | 3 Participants | 6 Participants | 3 Participants | 12 Participants |
| Comorbidities Peptic Ulcer Disease | 21 Participants | 30 Participants | 35 Participants | 86 Participants |
| Comorbidities Peripheral Vascular Disease | 28 Participants | 9 Participants | 42 Participants | 79 Participants |
| COVID-19 diagnosis location Inpatient | 176 Diagnosis location | 176 Diagnosis location | — | 352 Diagnosis location |
| COVID-19 diagnosis location Outpatient | 310 Diagnosis location | 930 Diagnosis location | — | 1240 Diagnosis location |
| C-Reactive Protein (CRP) at COVID-19 diagnosis | 12.6 mg/L STANDARD_DEVIATION 18.7 | 13.6 mg/L STANDARD_DEVIATION 21.8 | — | 13.1 mg/L STANDARD_DEVIATION 20.3 |
| Drug treatment for COVID-19 Anticoagulants | 13 Participants | 18 Participants | — | 31 Participants |
| Drug treatment for COVID-19 Anti-IL1 Inhibitors | 2 Participants | 1 Participants | — | 3 Participants |
| Drug treatment for COVID-19 Anti-IL6 Inhibitors | 8 Participants | 20 Participants | — | 28 Participants |
| Drug treatment for COVID-19 Azithromycin | 39 Participants | 46 Participants | — | 85 Participants |
| Drug treatment for COVID-19 Glucocorticoids | 32 Participants | 53 Participants | — | 85 Participants |
| Drug treatment for COVID-19 Hydroxychloroquine | 62 Participants | 49 Participants | — | 111 Participants |
| Drug treatment for COVID-19 Lopinavir/ritonavir | 25 Participants | 36 Participants | — | 61 Participants |
| Drug treatment for COVID-19 Monoclonal antibodies against SARS-CoV2 | 1 Participants | 7 Participants | — | 8 Participants |
| Drug treatment for COVID-19 Other antibiotics | 39 Participants | 44 Participants | — | 83 Participants |
| Drug treatment for COVID-19 Others | 18 Participants | 33 Participants | — | 51 Participants |
| Drug treatment for COVID-19 Reconvalescent plasma | 3 Participants | 1 Participants | — | 4 Participants |
| Drug treatment for COVID-19 Remdesivir | 9 Participants | 14 Participants | — | 23 Participants |
| Drug treatment for COVID-19 Tocilizumab | 5 Participants | 3 Participants | — | 8 Participants |
| Ferritin and D-dimer levels at COVID-19 diagnosis D-dimer | 1653.8 ng/mL STANDARD_DEVIATION 2452.7 | 1561.9 ng/mL STANDARD_DEVIATION 2299.8 | — | 1607.9 ng/mL STANDARD_DEVIATION 2371 |
| Ferritin and D-dimer levels at COVID-19 diagnosis Ferritin | 1039.5 ng/mL STANDARD_DEVIATION 1398.8 | 1113.0 ng/mL STANDARD_DEVIATION 1143.6 | — | 1076.6 ng/mL STANDARD_DEVIATION 1271.5 |
| Glucose, Cholesterol and Triglycerides at COVID-19 diagnosis Glucose | 7.0 mmol/L STANDARD_DEVIATION 3.6 | 7.4 mmol/L STANDARD_DEVIATION 5.1 | — | 7.2 mmol/L STANDARD_DEVIATION 4.4 |
| Glucose, Cholesterol and Triglycerides at COVID-19 diagnosis Total cholesterol | 4.4 mmol/L STANDARD_DEVIATION 0.9 | 3.8 mmol/L STANDARD_DEVIATION 1.3 | — | 4.1 mmol/L STANDARD_DEVIATION 1.1 |
| Glucose, Cholesterol and Triglycerides at COVID-19 diagnosis Triglycerides | 1.6 mmol/L STANDARD_DEVIATION 0.9 | 1.9 mmol/L STANDARD_DEVIATION 1.3 | — | 1.8 mmol/L STANDARD_DEVIATION 1.1 |
| Haematocrit at COVID-19 diagnosis | 2.8 L/L STANDARD_DEVIATION 3 | 2.8 L/L STANDARD_DEVIATION 3.3 | — | 2.8 L/L STANDARD_DEVIATION 3.2 |
| Haemoglobin at COVID-19 diagnosis | 13.0 g/dL STANDARD_DEVIATION 2.3 | 13.1 g/dL STANDARD_DEVIATION 2.2 | — | 13.1 g/dL STANDARD_DEVIATION 2.2 |
| HbA1C levels at COVID-19 diagnosis | 60.5 mmol/mol STANDARD_DEVIATION 36.7 | 99.9 mmol/mol STANDARD_DEVIATION 72 | — | 79.9 mmol/mol STANDARD_DEVIATION 56.8 |
| HIV viral load <50 copies/ml | 423 Participants | — | 878 Participants | 1301 Participants |
| HIV viral load ≥50 copies/ml | 69 Participants | — | 98 Participants | 167 Participants |
| Inflammatory Markers and Kidney Function Tests Calcium | 4.9 mg/dL STANDARD_DEVIATION 3.2 | 5.7 mg/dL STANDARD_DEVIATION 9 | — | 5.3 mg/dL STANDARD_DEVIATION 6.7 |
| Inflammatory Markers and Kidney Function Tests Serum creatinine | 1.8 mg/dL STANDARD_DEVIATION 3.3 | 1.1 mg/dL STANDARD_DEVIATION 1.1 | — | 1.4 mg/dL STANDARD_DEVIATION 2.5 |
| Inflammatory Markers and Kidney Function Tests Total bilirubin | 0.7 mg/dL STANDARD_DEVIATION 0.9 | 0.7 mg/dL STANDARD_DEVIATION 0.9 | — | 0.7 mg/dL STANDARD_DEVIATION 0.9 |
| Inflammatory Markers and Kidney Function Tests Urea | 52.6 mg/dL STANDARD_DEVIATION 64 | 39.7 mg/dL STANDARD_DEVIATION 30.2 | — | 46.1 mg/dL STANDARD_DEVIATION 50.3 |
| Lactate dehydrogenase, ALT and AST levels at COVID-19 diagnosis ALT | 42.0 U/L STANDARD_DEVIATION 78.9 | 47.4 U/L STANDARD_DEVIATION 44.7 | — | 44.7 U/L STANDARD_DEVIATION 63.9 |
| Lactate dehydrogenase, ALT and AST levels at COVID-19 diagnosis AST | 55.2 U/L STANDARD_DEVIATION 118.4 | 54.0 U/L STANDARD_DEVIATION 50.5 | — | 54.6 U/L STANDARD_DEVIATION 90.6 |
| Lactate dehydrogenase, ALT and AST levels at COVID-19 diagnosis Lactate dehydrogenase | 357.5 U/L STANDARD_DEVIATION 205.3 | 412.2 U/L STANDARD_DEVIATION 237.1 | — | 384.9 U/L STANDARD_DEVIATION 222.8 |
| MCH at COVID-19 diagnosis | 30.2 pg STANDARD_DEVIATION 2.8 | 29.1 pg STANDARD_DEVIATION 2.4 | — | 29.6 pg STANDARD_DEVIATION 2.7 |
| MCV at COVID diagnosis | 91.4 fL STANDARD_DEVIATION 7.3 | 87.3 fL STANDARD_DEVIATION 8.6 | — | 89.3 fL STANDARD_DEVIATION 8.2 |
| Month of COVID-19 diagnosis | 102020 month/year | 102020 month/year | — | 102020 month/year |
| Race/Ethnicity, Customized Ethnicity Asian | 4 Participants | 4 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Ethnicity Black | 163 Participants | 86 Participants | 329 Participants | 578 Participants |
| Race/Ethnicity, Customized Ethnicity Not stated | 58 Participants | 78 Participants | 120 Participants | 256 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 12 Participants | 4 Participants | 23 Participants | 39 Participants |
| Race/Ethnicity, Customized Ethnicity White Caucasian | 226 Participants | 148 Participants | 464 Participants | 838 Participants |
| Race/Ethnicity, Customized Ethnicity White Mixed | 37 Participants | 24 Participants | 49 Participants | 110 Participants |
| RBC Count at COVID-19 Diagnosis | 4.4 10^12/L cells STANDARD_DEVIATION 0.8 | 4.6 10^12/L cells STANDARD_DEVIATION 0.7 | — | 4.5 10^12/L cells STANDARD_DEVIATION 0.8 |
| Region of Enrollment Belgium | 50 Participants | 144 Participants | 4 Participants | 198 Participants |
| Region of Enrollment France | 53 Participants | 230 Participants | 682 Participants | 965 Participants |
| Region of Enrollment Netherlands | 38 Participants | 78 Participants | 24 Participants | 140 Participants |
| Region of Enrollment Spain | 165 Participants | 321 Participants | 116 Participants | 602 Participants |
| Region of Enrollment United Kingdom | 194 Participants | 333 Participants | 166 Participants | 693 Participants |
| Sex: Female, Male Female | 176 Participants | 409 Participants | 348 Participants | 933 Participants |
| Sex: Female, Male Male | 324 Participants | 697 Participants | 644 Participants | 1665 Participants |
| Time since HIV diagnosis | 17.8 years STANDARD_DEVIATION 9.5 | — | 18.7 years STANDARD_DEVIATION 9.3 | 18.4 years STANDARD_DEVIATION 9.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 24 / 486 | 23 / 1,106 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 224 / 486 | 231 / 1,106 |
Outcome results
Primary
Body Weight
Identification of risk factors for COVID-19 infection within the group of PLHIV: Body weight
Time frame: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Population: The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 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). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Body Weight | 80 kg |
| HIV Seronegative Patients With COVID-19 Controls | Body Weight | 77 kg |
Comparison: Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculatedp-value: <0.00195% CI: [1.34, 2.25]Regression, Logistic
Primary
CD4 Cell Count
Identification of risk factors for COVID-19 infection within the group of PLHIV: 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)
Population: The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 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). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLWHIV With COVID-19 Cases | CD4 Cell Count | 630 per 100 unit for the model |
| HIV Seronegative Patients With COVID-19 Controls | CD4 Cell Count | 630 per 100 unit for the model |
Comparison: Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculatedp-value: 0.45895% CI: [0.95, 1.02]Regression, Logistic
Primary
Chronic Kidney Disease
Identification of risk factors for COVID-19 infection within the group of PLHIV: 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)
Population: The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 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). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Chronic Kidney Disease | 38 participants |
| HIV Seronegative Patients With COVID-19 Controls | Chronic Kidney Disease | 32 participants |
Comparison: Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculatedp-value: <0.00195% CI: [1.61, 4.57]Regression, Logistic
Primary
Chronic Obstructive Pulmonary Disease
Identification of risk factors for COVID-19 infection within the group of PLHIV: 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)
Population: The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 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). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Chronic Obstructive Pulmonary Disease | 36 participants |
| HIV Seronegative Patients With COVID-19 Controls | Chronic Obstructive Pulmonary Disease | 43 participants |
Comparison: Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculatedp-value: 0.01295% CI: [1.16, 3.22]Regression, Logistic
Primary
HIV Viral Load
Identification of risk factors for COVID-19 infection within the group of PLHIV: 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)
Population: The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 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). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PLWHIV With COVID-19 Cases | HIV Viral Load | <50 | 427 copies/ml |
| PLWHIV With COVID-19 Cases | HIV Viral Load | ≥50 | 73 copies/ml |
| HIV Seronegative Patients With COVID-19 Controls | HIV Viral Load | <50 | 888 copies/ml |
| HIV Seronegative Patients With COVID-19 Controls | HIV Viral Load | ≥50 | 104 copies/ml |
Comparison: Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19.p-value: 0.009Regression, Logistic
Primary
Kaplan-Meier Estimate of Primary End Point
Kaplan-Meier estimate of the composite number of critical care admission, palliative discharge and death events
Time frame: From Baseline (diagnosis of COVID-19 ) to week 6
Population: There were 486 HIV+COVID+ cases included in the analysis as 14 cases lacked HIV-COVID+ inpatient controls and were excluded. This measure was analysed in participants diagnosed with COVID-19 and is not reported for the HIV+COVID-19- arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Kaplan-Meier Estimate of Primary End Point | 13.6 percentage of events |
| HIV Seronegative Patients With COVID-19 Controls | Kaplan-Meier Estimate of Primary End Point | 6.1 percentage of events |
95% CI: [0.73, 2.29]
Comparison: The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.95% CI: [0.73, 2.29]
Primary
Mortality
Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital
Time frame: Baseline (diagnosis of COVID-19) to week 6
Population: 486 HIV+COVID+ vs HIV-COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked COVID+ inpatient controls and were excluded. This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Mortality | 24 Participants |
| HIV Seronegative Patients With COVID-19 Controls | Mortality | 23 Participants |
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
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.
Time frame: From baseline (diagnosis of COVID-19) to Week 6
Population: There were 486 HIV+COVID+ cases included in the analysis as 14 cases lacked HIV-COVID+ inpatient controls and were excluded. This outcome was analysed in participants diagnosed with COVID-19 and is not applicable and not reported to the HIV+COVID-19- arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLWHIV With COVID-19 Cases | 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 Events |
| HIV Seronegative Patients With COVID-19 Controls | 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 | 67 Events |
Primary
Number of Critical Care Admission Events
Number of admission events to a high dependency unit or intensive care unit
Time frame: Baseline (diagnosis of COVID-19) to week 6
Population: 486 HIV+COVID+ vs HIV-COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked COVID+ inpatient controls and were excluded. This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Number of Critical Care Admission Events | 55 events |
| HIV Seronegative Patients With COVID-19 Controls | Number of Critical Care Admission Events | 58 events |
Primary
Number of Palliative Discharge
Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events
Time frame: Baseline (diagnosis of COVID-19) to week 6
Population: 486 HIV+COVID+ vs HIV-COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked COVID+ inpatient controls. This measure was analysed for participants with COVID-19 .It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Number of Palliative Discharge | 1 Participants |
| HIV Seronegative Patients With COVID-19 Controls | Number of Palliative Discharge | 0 Participants |
Primary
Time Since HIV Diagnosis
Identification of risk factors for COVID-19 infection within the group of PLHIV: 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)
Population: The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 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). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Time Since HIV Diagnosis | 17.1 per 10 unit of the model |
| HIV Seronegative Patients With COVID-19 Controls | Time Since HIV Diagnosis | 18.3 per 10 unit of the model |
Comparison: Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculatedp-value: 0.03395% CI: [0.74, 0.99]Regression, Logistic
Secondary
Biological Parameters at COVID-19 Diagnosis
Biological parameters (D-dimer and Ferritin levels) at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Population: The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had D-dimer and Ferritin levels data available and could not be included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PLWHIV With COVID-19 Cases | Biological Parameters at COVID-19 Diagnosis | D-dimer | 1653.8 ng/mL |
| PLWHIV With COVID-19 Cases | Biological Parameters at COVID-19 Diagnosis | Ferritin | 1039.5 ng/mL |
| HIV Seronegative Patients With COVID-19 Controls | Biological Parameters at COVID-19 Diagnosis | D-dimer | 1561.9 ng/mL |
| HIV Seronegative Patients With COVID-19 Controls | Biological Parameters at COVID-19 Diagnosis | Ferritin | 1113.0 ng/mL |
Secondary
Blood Cell Counts at COVID-19 Diagnosis
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
Time frame: Baseline (Diagnosis of COVID-19)
Population: Due to the retrospective nature of this data collection study, not all patients in the PLWHIV with COVID and the HIV seronegative with COVID groups had blood cell counts available and could not be included in the analysis. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PLWHIV With COVID-19 Cases | Blood Cell Counts at COVID-19 Diagnosis | Neutrophils | 7.0 10^9/L cells |
| PLWHIV With COVID-19 Cases | Blood Cell Counts at COVID-19 Diagnosis | Monocytes | 1.0 10^9/L cells |
| PLWHIV With COVID-19 Cases | Blood Cell Counts at COVID-19 Diagnosis | WBC count | 7.2 10^9/L cells |
| PLWHIV With COVID-19 Cases | Blood Cell Counts at COVID-19 Diagnosis | Eosinophils | 0.07 10^9/L cells |
| PLWHIV With COVID-19 Cases | Blood Cell Counts at COVID-19 Diagnosis | Lymphocytes | 2.0 10^9/L cells |
| PLWHIV With COVID-19 Cases | Blood Cell Counts at COVID-19 Diagnosis | Basophils | 0.05 10^9/L cells |
| PLWHIV With COVID-19 Cases | Blood Cell Counts at COVID-19 Diagnosis | Platelet count | 212.1 10^9/L cells |
| HIV Seronegative Patients With COVID-19 Controls | Blood Cell Counts at COVID-19 Diagnosis | Basophils | 0.04 10^9/L cells |
| HIV Seronegative Patients With COVID-19 Controls | Blood Cell Counts at COVID-19 Diagnosis | Platelet count | 237.2 10^9/L cells |
| HIV Seronegative Patients With COVID-19 Controls | Blood Cell Counts at COVID-19 Diagnosis | WBC count | 7.4 10^9/L cells |
| HIV Seronegative Patients With COVID-19 Controls | Blood Cell Counts at COVID-19 Diagnosis | Neutrophils | 8.3 10^9/L cells |
| HIV Seronegative Patients With COVID-19 Controls | Blood Cell Counts at COVID-19 Diagnosis | Lymphocytes | 1.8 10^9/L cells |
| HIV Seronegative Patients With COVID-19 Controls | Blood Cell Counts at COVID-19 Diagnosis | Monocytes | 0.7 10^9/L cells |
| HIV Seronegative Patients With COVID-19 Controls | Blood Cell Counts at COVID-19 Diagnosis | Eosinophils | 0.13 10^9/L cells |
Secondary
Cholesterol, Triglyceride and Glucose Levels
Cholesterol, Triglyceride and Glucose levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Population: The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had Cholesterol, Triglyceride and Glucose data available and could not be included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PLWHIV With COVID-19 Cases | Cholesterol, Triglyceride and Glucose Levels | Total Cholesterol | 4.4 mmol/L |
| PLWHIV With COVID-19 Cases | Cholesterol, Triglyceride and Glucose Levels | Total Triglycerides | 1.6 mmol/L |
| PLWHIV With COVID-19 Cases | Cholesterol, Triglyceride and Glucose Levels | Glucose | 7.0 mmol/L |
| HIV Seronegative Patients With COVID-19 Controls | Cholesterol, Triglyceride and Glucose Levels | Total Cholesterol | 3.8 mmol/L |
| HIV Seronegative Patients With COVID-19 Controls | Cholesterol, Triglyceride and Glucose Levels | Total Triglycerides | 1.9 mmol/L |
| HIV Seronegative Patients With COVID-19 Controls | Cholesterol, Triglyceride and Glucose Levels | Glucose | 7.4 mmol/L |
Secondary
C-reactive Protein Levels
C-reactive protein levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Population: The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had CRP data available and could not be included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | C-reactive Protein Levels | 12.6 mg/L |
| HIV Seronegative Patients With COVID-19 Controls | C-reactive Protein Levels | 13.6 mg/L |
Secondary
Estimate Risk of 30-day Mortality After COVID-19 Infection
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.
Time frame: Baseline (diagnosis of COVID-19) to week 6
Population: This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm. Data required to analyse this measure was not available for all participants in the HIV+COVID+ and HIV-COVID+ groups due to the retrospective nature of this study, and was only collected for 172 participants per group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Estimate Risk of 30-day Mortality After COVID-19 Infection | 2.65 percentage of 30- day mortality risk |
| HIV Seronegative Patients With COVID-19 Controls | Estimate Risk of 30-day Mortality After COVID-19 Infection | 2.00 percentage of 30- day mortality risk |
Secondary
Extracorporeal Membrane Oxygenation (ECMO)
Length of extracorporeal membrane oxygenation
Time frame: Baseline (diagnosis of COVID-19) to week 6
Population: Data was not collected
Secondary
Haematocrit
Haematocrit levels at COVID-19 diagnosis
Time frame: Baseline (COVID-19 diagnosis)
Population: The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had Haematocrit data available and could not be included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Haematocrit | 2.8 L/L |
| HIV Seronegative Patients With COVID-19 Controls | Haematocrit | 2.8 L/L |
Secondary
Haemoglobin Levels
Haemoglobin levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Population: The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had Haemoglobin data available and could not be included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Haemoglobin Levels | 13.0 g/dL |
| HIV Seronegative Patients With COVID-19 Controls | Haemoglobin Levels | 13.1 g/dL |
Secondary
HbA1C Levels
Glycated Haemoglobin (HbA1C) levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Population: The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had HbA1C data available and could not be included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | HbA1C Levels | 60.5 mmol/mol |
| HIV Seronegative Patients With COVID-19 Controls | HbA1C Levels | 99.2 mmol/mol |
Secondary
Inflammatory Markers and Kidney Function Tests
Inflammatory markers and Kidney Function tests at COVID-19 diagnosis
Time frame: Baseline (COVID-19 Diagnosis)
Population: The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had kidney function and inflammatory marker data available and could not be included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PLWHIV With COVID-19 Cases | Inflammatory Markers and Kidney Function Tests | Total Bilirubin | 0.7 mg/dL |
| PLWHIV With COVID-19 Cases | Inflammatory Markers and Kidney Function Tests | Urea | 52.6 mg/dL |
| PLWHIV With COVID-19 Cases | Inflammatory Markers and Kidney Function Tests | Serum creatinine | 1.8 mg/dL |
| PLWHIV With COVID-19 Cases | Inflammatory Markers and Kidney Function Tests | Calcium | 4.9 mg/dL |
| HIV Seronegative Patients With COVID-19 Controls | Inflammatory Markers and Kidney Function Tests | Calcium | 5.7 mg/dL |
| HIV Seronegative Patients With COVID-19 Controls | Inflammatory Markers and Kidney Function Tests | Total Bilirubin | 0.7 mg/dL |
| HIV Seronegative Patients With COVID-19 Controls | Inflammatory Markers and Kidney Function Tests | Serum creatinine | 1.1 mg/dL |
| HIV Seronegative Patients With COVID-19 Controls | Inflammatory Markers and Kidney Function Tests | Urea | 39.7 mg/dL |
Secondary
Length of Hospital Stay
Length of stay in hospital following hospitalisation for COVID-19
Time frame: Baseline (diagnosis of COVID-19) to week 6
Population: 486 HIV+COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked HIV-COVID+ inpatient controls and were excluded. This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Length of Hospital Stay | 11 days |
| HIV Seronegative Patients With COVID-19 Controls | Length of Hospital Stay | 9 days |
Secondary
Length of Stay in ICU
Median Length of Stay in Intensive Care Unit
Time frame: Baseline (diagnosis of COVID-19) to week 6
Population: 486 HIV+COVID+ vs HIV-COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked COVID+ inpatient controls. This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Length of Stay in ICU | 18 days |
| HIV Seronegative Patients With COVID-19 Controls | Length of Stay in ICU | 7 days |
Secondary
Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis
The endpoint is the liver function (ALT, AST) and tissue damage (lactate dehydrogenase) parameters at COVID-19 diagnosis.
Time frame: Baseline(COVID-19 diagnosis)
Population: The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had liver function data available and could not be included in the analysis. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PLWHIV With COVID-19 Cases | Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis | ALT | 42.0 U/L |
| PLWHIV With COVID-19 Cases | Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis | AST | 55.2 U/L |
| PLWHIV With COVID-19 Cases | Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis | Lactate dehydrogenase | 357.5 U/L |
| HIV Seronegative Patients With COVID-19 Controls | Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis | ALT | 47.4 U/L |
| HIV Seronegative Patients With COVID-19 Controls | Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis | AST | 54.0 U/L |
| HIV Seronegative Patients With COVID-19 Controls | Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis | Lactate dehydrogenase | 412.2 U/L |
Secondary
MCH Levels
Mean Corpuscular Haemoglobin levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Population: The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had MCH data available and could not be included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | MCH Levels | 30.2 pg |
| HIV Seronegative Patients With COVID-19 Controls | MCH Levels | 29.1 pg |
Secondary
MCV Levels
Mean Corpuscular volume (MCV) levels at COVID-19 diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Population: The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had MCV data available and could not be included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | MCV Levels | 91.4 fL |
| HIV Seronegative Patients With COVID-19 Controls | MCV Levels | 87.3 fL |
Secondary
Measurement of Total Comorbidity Burden
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.
Time frame: 6 weeks after diagnosis of COVID-19
Population: This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm. Co-morbidity data required to analyse this measure was not available for all participants in the HIV+COVID+ and HIV-COVID+ groups due to the retrospective nature of this study, and was only collected for 170 participants per group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Measurement of Total Comorbidity Burden | 2.35 score on a scale |
| HIV Seronegative Patients With COVID-19 Controls | Measurement of Total Comorbidity Burden | 0.99 score on a scale |
Secondary
Need for Kidney Replacement Therapy
The number of patients requiring kidney replacement therapy
Time frame: Baseline(diagnosis of COVID-19) to week 6
Population: This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm. Kidney replacement data was not available for all participants in the HIV+COVID+ and HIV-COVID+ groups due to the retrospective nature of this study, and was only collected for 129 participants per group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Need for Kidney Replacement Therapy | 13 participants |
| HIV Seronegative Patients With COVID-19 Controls | Need for Kidney Replacement Therapy | 6 participants |
Secondary
Number of Hospitalisation Events
Number of hospital admission for COVID-19 events
Time frame: Baseline (diagnosis of COVID-19) to week 6
Population: 486 HIV+COVID+ vs HIV-COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked HIV-COVID+ inpatient controls and were excluded. This measure was analysed for participants hospitalised with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Number of Hospitalisation Events | 200 events |
| HIV Seronegative Patients With COVID-19 Controls | Number of Hospitalisation Events | 208 events |
Secondary
Red Blood Cell Count
Red blood cell (RBC) count at COVID-19 Diagnosis
Time frame: Baseline(COVID-19 Diagnosis)
Population: The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had Red Blood Cell count data available and could not be included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWHIV With COVID-19 Cases | Red Blood Cell Count | 4.4 10^12/L cells |
| HIV Seronegative Patients With COVID-19 Controls | Red Blood Cell Count | 4.6 10^12/L cells |
Secondary
Ventilator-free Days (VFDs)
Number of ventilator-free days
Time frame: 6 weeks after diagnosis of COVID-19
Population: Data was not collected