Trial · NCT05481216
HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
NCT05481216, Completed, NEAT ID Foundation; results first posted 2025-03-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV. Trials, record NCT05481216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05481216
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
- NCT number
- NCT05481216
- Status
- Completed
- Enrollment
- 2,598 participants, actual
- Lead sponsor
- NEAT ID Foundation
- Conditions
- HIV-1-infection, COVID-19
- Interventions
- COVID-19, HIV-1 infection
- First posted
- 2022-08-01
- Last updated
- 2025-03-24
- Results first posted
- 2025-03-24
- Limitations and caveats
There are two analysis groups: exposed/unexposed (HIV+COVID-19+ and HIV-COVID-19+) and case-control (HIV+COVID-19+ and HIV+COVID-19-). There are limitations in data availability as this is a retrospective data collection study and all variables could not be collected for all participants. Multiple imputation using Chained Equations approach (MICE) was used to fill in missing data.
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | PLWHIV With COVID-19 Cases | 66 | Events | ||
| 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 | HIV Seronegative Patients With COVID-19 Controls | 67 | Events | ||
| Kaplan-Meier Estimate of Primary End Point | PLWHIV With COVID-19 Cases | 13.6 | 95% Confidence Interval 10.8 to 17.0 | percentage of events | |
| Kaplan-Meier Estimate of Primary End Point | HIV Seronegative Patients With COVID-19 Controls | 6.1 | 95% Confidence Interval 4.8 to 7.6 | percentage of events | |
| Number of Palliative Discharge | PLWHIV With COVID-19 Cases | 1 | Participants | ||
| Number of Palliative Discharge | HIV Seronegative Patients With COVID-19 Controls | 0 | Participants | ||
| Mortality | PLWHIV With COVID-19 Cases | 24 | Participants | ||
| Mortality | HIV Seronegative Patients With COVID-19 Controls | 23 | Participants | ||
| Number of Critical Care Admission Events | PLWHIV With COVID-19 Cases | 55 | events | ||
| Number of Critical Care Admission Events | HIV Seronegative Patients With COVID-19 Controls | 58 | events |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PLWHIV With COVID-19 Cases | 500 | |
| Overall Study | STARTED | PLWHIV Without COVID-19 Controls | 992 | |
| Overall Study | STARTED | HIV Seronegative Patients With COVID-19 Controls | 1,106 | |
| Overall Study | COMPLETED | PLWHIV With COVID-19 Cases | 500 | |
| Overall Study | COMPLETED | PLWHIV Without COVID-19 Controls | 992 | |
| Overall Study | COMPLETED | HIV Seronegative Patients With COVID-19 Controls | 1,106 | |
| Overall Study | NOT COMPLETED | PLWHIV With COVID-19 Cases | 0 | |
| Overall Study | NOT COMPLETED | PLWHIV Without COVID-19 Controls | 0 | |
| Overall Study | NOT COMPLETED | HIV Seronegative Patients With COVID-19 Controls | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Mortality | General disorders | PLWHIV With COVID-19 Cases | 24 | 486 | |
| serious | Mortality | General disorders | HIV Seronegative Patients With COVID-19 Controls | 23 | 1,106 | |
| serious | Hospitalisation | General disorders | PLWHIV With COVID-19 Cases | 200 | 486 | |
| serious | Hospitalisation | General disorders | HIV Seronegative Patients With COVID-19 Controls | 208 | 1,106 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PLWHIV With COVID-19 Cases | 24 | 486 |
| Total, all-cause mortality | HIV Seronegative Patients With COVID-19 Controls | 23 | 1,106 |
| Total, other adverse events | PLWHIV With COVID-19 Cases | 0 | 0 |
| Total, other adverse events | HIV Seronegative Patients With COVID-19 Controls | 0 | 0 |
| Total, serious adverse events | PLWHIV With COVID-19 Cases | 224 | 486 |
| Total, serious adverse events | HIV Seronegative Patients With COVID-19 Controls | 231 | 1,106 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PLWHIV With COVID-19 Cases vs HIV Seronegative Patients With COVID-19 Controls: Need for Kidney Replacement Therapy | Trial comparisons |
| PLWHIV With COVID-19 Cases vs PLWHIV Without COVID-19 Controls: Chronic Kidney Disease | Trial comparisons |
| PLWHIV With COVID-19 Cases vs HIV Seronegative Patients With COVID-19 Controls: Mortality | Trial comparisons |
| PLWHIV With COVID-19 Cases vs HIV Seronegative Patients With COVID-19 Controls: deaths from any cause | Trial comparisons |
| PLWHIV With COVID-19 Cases vs HIV Seronegative Patients With COVID-19 Controls: Number of Palliative Discharge | Trial comparisons |
| PLWHIV With COVID-19 Cases vs PLWHIV Without COVID-19 Controls: Chronic Obstructive Pulmonary Disease | Trial comparisons |
| PLWHIV With COVID-19 Cases vs HIV Seronegative Patients With COVID-19 Controls: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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