Trial · NCT05481216
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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. |
| Primary | 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 |
| Primary | 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 |
| Primary | Mortality | Baseline (diagnosis of COVID-19) to week 6 | Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital |
| Primary | 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 |
| Primary | 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 |
| Primary | 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 |
| Primary | 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 |
| Primary | 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 |
| Primary | 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 |
| Primary | 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 | Number of Hospitalisation Events | Baseline (diagnosis of COVID-19) to week 6 | Number of hospital admission for COVID-19 events |
| Secondary | Length of Hospital Stay | Baseline (diagnosis of COVID-19) to week 6 | Length of stay in hospital following hospitalisation for COVID-19 |
| Secondary | Length of Stay in ICU | Baseline (diagnosis of COVID-19) to week 6 | Median Length of Stay in Intensive Care Unit |
| Secondary | Ventilator-free Days (VFDs) | 6 weeks after diagnosis of COVID-19 | Number of ventilator-free days |
| Secondary | Extracorporeal Membrane Oxygenation (ECMO) | Baseline (diagnosis of COVID-19) to week 6 | Length of extracorporeal membrane oxygenation |
| Secondary | Need for Kidney Replacement Therapy | Baseline(diagnosis of COVID-19) to week 6 | The number of patients requiring kidney replacement therapy |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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 |
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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