Trial · NCT05481216
Outcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | From baseline (diagnosis of COVID-19) to Week 6 | 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. | Events | NUMBER |
| PRIMARY | Kaplan-Meier Estimate of Primary End Point | From Baseline (diagnosis of COVID-19 ) to week 6 | 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. | percentage of events | NUMBER |
| PRIMARY | Number of Palliative Discharge | Baseline (diagnosis of COVID-19) to week 6 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mortality | Baseline (diagnosis of COVID-19) to week 6 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Critical Care Admission Events | Baseline (diagnosis of COVID-19) to week 6 | 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. | events | NUMBER |
| PRIMARY | HIV Viral Load | Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19) | 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. | copies/ml | NUMBER |
| SECONDARY | Number of Hospitalisation Events | Baseline (diagnosis of COVID-19) to week 6 | 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. | events | NUMBER |
| SECONDARY | Length of Hospital Stay | Baseline (diagnosis of COVID-19) to week 6 | 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. | days | MEDIAN |
| SECONDARY | Length of Stay in ICU | Baseline (diagnosis of COVID-19) to week 6 | 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. | days | MEDIAN |
| SECONDARY | Ventilator-free Days (VFDs) | 6 weeks after diagnosis of COVID-19 | Data was not collected | ||
| SECONDARY | Extracorporeal Membrane Oxygenation (ECMO) | Baseline (diagnosis of COVID-19) to week 6 | Data was not collected | ||
| SECONDARY | Need for Kidney Replacement Therapy | Baseline(diagnosis of COVID-19) to week 6 | 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. | participants | NUMBER |
| SECONDARY | Measurement of Total Comorbidity Burden | 6 weeks after diagnosis of COVID-19 | 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. | score on a scale | MEAN |
| SECONDARY | Estimate Risk of 30-day Mortality After COVID-19 Infection | Baseline (diagnosis of COVID-19) to week 6 | 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. | percentage of 30- day mortality risk | MEDIAN |
| SECONDARY | Blood Cell Counts at COVID-19 Diagnosis | Baseline (Diagnosis of COVID-19) | 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. | 10^9/L cells | MEAN |
| SECONDARY | Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis | Baseline(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. | U/L | MEAN |
| SECONDARY | Inflammatory Markers and Kidney Function Tests | Baseline (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. | mg/dL | MEAN |
| SECONDARY | Biological Parameters at COVID-19 Diagnosis | Baseline(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. | ng/mL | MEAN |
| SECONDARY | Cholesterol, Triglyceride and Glucose Levels | Baseline(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. | mmol/L | MEAN |
| SECONDARY | Red Blood Cell Count | Baseline(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. | 10^12/L cells | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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