| 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.
| 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. | Posted | | Number | | Events | | From baseline (diagnosis of COVID-19) to Week 6 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
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| Primary | Kaplan-Meier Estimate of Primary End Point | Kaplan-Meier estimate of the composite number of critical care admission, palliative discharge and death events | 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. | Posted | | Number | 95% Confidence Interval | percentage of events | | From Baseline (diagnosis of COVID-19 ) to week 6 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Number of Palliative Discharge | Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events | 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. | Posted | | Count of Participants | | Participants | | Baseline (diagnosis of COVID-19) to week 6 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Mortality | Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital | 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. | Posted | | Count of Participants | | Participants | | Baseline (diagnosis of COVID-19) to week 6 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Number of Critical Care Admission Events | Number of admission events to a high dependency unit or intensive care unit | 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. | Posted | | Number | | events | | Baseline (diagnosis of COVID-19) to week 6 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | HIV Viral Load | Identification of risk factors for COVID-19 infection within the group of PLHIV: HIV viral load | 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. | Posted | | Number | | copies/ml | | Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Number of Hospitalisation Events | Number of hospital admission for COVID-19 events | 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. | Posted | | Number | | events | | Baseline (diagnosis of COVID-19) to week 6 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Length of Hospital Stay | Length of stay in hospital following hospitalisation for COVID-19 | 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. | Posted | | Median | 95% Confidence Interval | days | | Baseline (diagnosis of COVID-19) to week 6 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Length of Stay in ICU | Median Length of Stay in Intensive Care Unit | 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. | Posted | | Median | 95% Confidence Interval | days | | Baseline (diagnosis of COVID-19) to week 6 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Ventilator-free Days (VFDs) | Number of ventilator-free days | | Posted | | | | | | 6 weeks after diagnosis of COVID-19 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Extracorporeal Membrane Oxygenation (ECMO) | Length of extracorporeal membrane oxygenation | | Posted | | | | | | Baseline (diagnosis of COVID-19) to week 6 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Need for Kidney Replacement Therapy | The number of patients requiring kidney replacement therapy | 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. | Posted | | Number | | participants | | Baseline(diagnosis of COVID-19) to week 6 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | 95% Confidence Interval | score on a scale | | 6 weeks after diagnosis of COVID-19 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | HIV Seronegative Patients With COVID-19 Controls |
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| 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. | 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. | Posted | | Median | Inter-Quartile Range | percentage of 30- day mortality risk | | Baseline (diagnosis of COVID-19) to week 6 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Mean | 95% Confidence Interval | 10^9/L cells | | Baseline (Diagnosis of COVID-19) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | 95% Confidence Interval | U/L | | Baseline(COVID-19 diagnosis) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Inflammatory Markers and Kidney Function Tests | Inflammatory markers and Kidney Function tests at COVID-19 diagnosis | 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. | Posted | | Mean | 95% Confidence Interval | mg/dL | | Baseline (COVID-19 Diagnosis) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Biological Parameters at COVID-19 Diagnosis | Biological parameters (D-dimer and Ferritin levels) at COVID-19 diagnosis | 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. | Posted | | Mean | 95% Confidence Interval | ng/mL | | Baseline(COVID-19 diagnosis) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Cholesterol, Triglyceride and Glucose Levels | Cholesterol, Triglyceride and Glucose levels at COVID-19 diagnosis | 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. | Posted | | Mean | 95% Confidence Interval | mmol/L | | Baseline(COVID-19 diagnosis) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Red Blood Cell Count | Red blood cell (RBC) count at COVID-19 Diagnosis | 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. | Posted | | Mean | 95% Confidence Interval | 10^12/L cells | | Baseline(COVID-19 Diagnosis) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Haemoglobin Levels | Haemoglobin levels at COVID-19 diagnosis | 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. | Posted | | Mean | 95% Confidence Interval | g/dL | | Baseline(COVID-19 diagnosis) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Haematocrit | Haematocrit levels at COVID-19 diagnosis | 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. | Posted | | Mean | 95% Confidence Interval | L/L | | Baseline (COVID-19 diagnosis) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | MCV Levels | Mean Corpuscular volume (MCV) levels at COVID-19 diagnosis | 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. | Posted | | Mean | 95% Confidence Interval | fL | | Baseline(COVID-19 diagnosis) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | MCH Levels | Mean Corpuscular Haemoglobin levels at COVID-19 diagnosis | 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. | Posted | | Mean | 95% Confidence Interval | pg | | Baseline(COVID-19 diagnosis) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | HbA1C Levels | Glycated Haemoglobin (HbA1C) levels at COVID-19 diagnosis | 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. | Posted | | Mean | 95% Confidence Interval | mmol/mol | | Baseline(COVID-19 diagnosis) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | C-reactive Protein Levels | C-reactive protein levels at COVID-19 diagnosis | 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. | Posted | | Mean | 95% Confidence Interval | mg/L | | Baseline(COVID-19 diagnosis) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Time Since HIV Diagnosis | Identification of risk factors for COVID-19 infection within the group of PLHIV: Time since HIV diagnosis | 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. | Posted | | Number | | per 10 unit of the model | | Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Chronic Obstructive Pulmonary Disease | Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Obstructive Pulmonary Disease | 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. | Posted | | Number | | participants | | Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | CD4 Cell Count | Identification of risk factors for COVID-19 infection within the group of PLHIV: CD4 cell count | 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. | Posted | | Number | | per 100 unit for the model | | Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Chronic Kidney Disease | Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Kidney Disease | 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. | Posted | | Number | | participants | | Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Body Weight | Identification of risk factors for COVID-19 infection within the group of PLHIV: Body weight | 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. | Posted | | Median | Inter-Quartile Range | kg | | Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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