HIV-1-infectionHIV CoCoNCT05481216
HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
An observational study of HIV-1-infection and COVID-19, run by NEAT ID Foundation at 23 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection, COVID-19
- What is being tested?
- COVID-19 and HIV-1 infection
- How many people
- 2,598 participants
- Where
- 23 sitesin 5 countries
- Study dates
- 29 Mar 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult PLWHIV with and without COVID-19 disease, followed up at the study sites for routine clinical care. Data from adult COVID-19 patients without HIV infection will be used as controls. 500 cases (PLWHIV + COVID-19) will be recruited. These patients will be at least 18 years old with documented HIV-1 infection and SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021. 500 COVID-19 controls will be recruited. These patients will be at least 18 years old without documented HIV-1 infection but 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. 1000 PLWHIV control patients will be recruited for the second control group. This group will include individuals at least 18 years old with documented HIV-1 infection.
Who may be able to join
- • Cases (PLWHIV + COVID-19)
- Any gender
- At least 18 years of age
- Documented HIV-1 infection
- 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)
Show all 29Show fewer
- <!-- -->
- Any gender
- At least 18 years of age
- No documented HIV-1 infection
- 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
- 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)
- Any gender
- At least 18 years of age
- Documented HIV-1 infection
- No evidence of SARS-CoV-2 infection
- 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)
Who cannot join
- For cases (PLWHIV + COVID-19) and for COVID-19 only controls:
- COVID-19 diagnosed based on clinical criteria
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
Spain10 sites
Hospital Clinic Barcelona
Barcelona
Hospital de la Santa Creu I Sant Pau
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitario Basurto
Bilbao
Hospital General Universitario de Elche
Elche
Hospital Universitario San Pedro
Logroño
Hospital Ramón y Cajal
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
United Kingdom9 sites
Bradford Teaching Hospitals NHS Foundation Trust
Bradford
Southmead Hospital (North Bristol)
Bristol
University Hospitals of Derby & Burton NHS Foundation Trust
Derby
Brownlee Centre, Gartnavel General Hospital
Glasgow
Barts Health (The Royal London Hospital)
London
Chelsea & Westminster Hospital NHS Foundation Trust
London
Guy's and St Thomas' NHS Foundation Trust
London
King's College Hospital NHS Foundation Trust
London
Royal Free London NHS Foundation Trust
London
About this study
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:
Read more
- Is there a particular risk for COVID-19 in PLWHIV as compared to HIV seronegative control COVID-19 cases?
- 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:
- Describe the differences in the clinical manifestation of COVID-19 in PLWHIV compared to HIV seronegative controls
- Describe the response to treatment, including supportive care and novel therapies against COVID-19, including antiviral or immunomodulatory therapy
- Describe the co-morbidities in PLWHIV and controls with COVID-19
- 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.
- Conditions
- HIV-1-infection, COVID-19
- Being tested
- COVID-19, HIV-1 infection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19Other
Diagnosed with COVID-19 infection
HIV-1 infectionOther
Diagnosed with HIV-1 infection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: COVID-19; Other: HIV-1 infection | |
| PLWHIV without COVID-19 controls | Patients at least 18 years of age with documented HIV-1 infection. Receives: Other: HIV-1 infection | |
| 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. Receives: Other: COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (diagnosis of COVID-19) to Week 6
Kaplan-Meier Estimate of Primary End Point
Kaplan-Meier estimate of the composite number of critical care admission, palliative discharge and death events
Measured: From Baseline (diagnosis of COVID-19 ) to week 6
Number of Palliative Discharge
Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events
Measured: Baseline (diagnosis of COVID-19) to week 6
Mortality
Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital
Measured: Baseline (diagnosis of COVID-19) to week 6
Number of Critical Care Admission Events
Number of admission events to a high dependency unit or intensive care unit
Measured: Baseline (diagnosis of COVID-19) to week 6
HIV Viral Load
Identification of risk factors for COVID-19 infection within the group of PLHIV: HIV viral load
Measured: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Time Since HIV Diagnosis
Identification of risk factors for COVID-19 infection within the group of PLHIV: Time since HIV diagnosis
Measured: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Chronic Obstructive Pulmonary Disease
Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Obstructive Pulmonary Disease
Measured: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
CD4 Cell Count
Identification of risk factors for COVID-19 infection within the group of PLHIV: CD4 cell count
Measured: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Chronic Kidney Disease
Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Kidney Disease
Measured: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Body Weight
Identification of risk factors for COVID-19 infection within the group of PLHIV: Body weight
Measured: Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)
Secondary outcomes (20)
Number of Hospitalisation Events
Number of hospital admission for COVID-19 events
Measured: Baseline (diagnosis of COVID-19) to week 6
Length of Hospital Stay
Length of stay in hospital following hospitalisation for COVID-19
Measured: Baseline (diagnosis of COVID-19) to week 6
Length of Stay in ICU
Median Length of Stay in Intensive Care Unit
Measured: Baseline (diagnosis of COVID-19) to week 6
Ventilator-free Days (VFDs)
Number of ventilator-free days
Measured: 6 weeks after diagnosis of COVID-19
Extracorporeal Membrane Oxygenation (ECMO)
Length of extracorporeal membrane oxygenation
Measured: Baseline (diagnosis of COVID-19) to week 6
Need for Kidney Replacement Therapy
The number of patients requiring kidney replacement therapy
Measured: Baseline(diagnosis of COVID-19) to week 6
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.
Measured: 6 weeks after diagnosis of COVID-19
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.
Measured: Baseline (diagnosis of COVID-19) to week 6
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
Measured: Baseline (Diagnosis of COVID-19)
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.
Measured: Baseline(COVID-19 diagnosis)
Inflammatory Markers and Kidney Function Tests
Inflammatory markers and Kidney Function tests at COVID-19 diagnosis
Measured: Baseline (COVID-19 Diagnosis)
Biological Parameters at COVID-19 Diagnosis
Biological parameters (D-dimer and Ferritin levels) at COVID-19 diagnosis
Measured: Baseline(COVID-19 diagnosis)
Cholesterol, Triglyceride and Glucose Levels
Cholesterol, Triglyceride and Glucose levels at COVID-19 diagnosis
Measured: Baseline(COVID-19 diagnosis)
Red Blood Cell Count
Red blood cell (RBC) count at COVID-19 Diagnosis
Measured: Baseline(COVID-19 Diagnosis)
Haemoglobin Levels
Haemoglobin levels at COVID-19 diagnosis
Measured: Baseline(COVID-19 diagnosis)
Haematocrit
Haematocrit levels at COVID-19 diagnosis
Measured: Baseline (COVID-19 diagnosis)
MCV Levels
Mean Corpuscular volume (MCV) levels at COVID-19 diagnosis
Measured: Baseline(COVID-19 diagnosis)
MCH Levels
Mean Corpuscular Haemoglobin levels at COVID-19 diagnosis
Measured: Baseline(COVID-19 diagnosis)
HbA1C Levels
Glycated Haemoglobin (HbA1C) levels at COVID-19 diagnosis
Measured: Baseline(COVID-19 diagnosis)
C-reactive Protein Levels
C-reactive protein levels at COVID-19 diagnosis
Measured: Baseline(COVID-19 diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start29 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- NEAT ID Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481216
- Sponsor's protocol ID
- 303CoCo
- Acronym
- HIV CoCo
- Status last verified
- Mar 2025
- First submitted
- 29 Jul 2022
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymised summary-format data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
- ClinicalTrials.gov ID
- NCT05481216
- Acronym / sponsor ID
- HIV CoCo / 303CoCo
- Conditions
- HIV-1-infection, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,598 participants (actual)
- Lead sponsor
- NEAT ID FoundationUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there a particular risk for COVID-19 in PLWHIV as compared to HIV seronegative control COVID-19 cases?
- 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:
- Describe the differences in the clinical manifestation of COVID-19 in PLWHIV compared to HIV seronegative controls
- Describe the response to treatment, including supportive care and novel therapies against COVID-19, including antiviral or immunomodulatory therapy
- Describe the co-morbidities in PLWHIV and controls with COVID-19
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLWHIV with COVID-19 cases | – | Other: COVID-19, Other: HIV-1 infectionPatients 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. |
| PLWHIV without COVID-19 controls | – | Other: HIV-1 infectionPatients at least 18 years of age with documented HIV-1 infection. |
| HIV seronegative patients with COVID-19 controls | – | Other: COVID-19Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult PLWHIV with and without COVID-19 disease, followed up at the study sites for routine clinical care. Data from adult COVID-19 patients without HIV infection will be used as controls. 500 cases (PLWHIV + COVID-19) will be recruited. These patients will be at least 18 years old with documented HIV-1 infection and SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021. 500 COVID-19 controls will be recruited. These patients will be at least 18 years old without documented HIV-1 infection but 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. 1000 PLWHIV control patients will be recruited for the second control group. This group will include individuals at least 18 years old with documented HIV-1 infection.
Key inclusion criteria (29 listed)
- • Cases (PLWHIV + COVID-19)
- <!-- -->
- 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
Key exclusion criteria (2 listed)
- COVID-19 diagnosed based on clinical criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19Diagnosed with COVID-19 infection | Other | HIV seronegative patients with COVID-19 controls, PLWHIV with COVID-19 cases |
| HIV-1 infectionDiagnosed with HIV-1 infection | Other | PLWHIV with COVID-19 cases, PLWHIV without COVID-19 controls |
Primary outcome
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
Time frame: 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
Time frame: 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
Time frame: Baseline (diagnosis of COVID-19) to week 6
Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events
Mortality
Time frame: 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
Time frame: Baseline (diagnosis of COVID-19) to week 6
Number of admission events to a high dependency unit or intensive care unit
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)
Identification of risk factors for COVID-19 infection within the group of PLHIV: HIV viral load
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)
Identification of risk factors for COVID-19 infection within the group of PLHIV: Time since HIV diagnosis
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)
Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Obstructive Pulmonary Disease
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)
Identification of risk factors for COVID-19 infection within the group of PLHIV: CD4 cell count
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)
Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Kidney Disease
Body Weight
Time frame: 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
20 secondary outcomes
Number of Hospitalisation Events
Time frame: Baseline (diagnosis of COVID-19) to week 6
Length of Hospital Stay
Time frame: Baseline (diagnosis of COVID-19) to week 6
Length of Stay in ICU
Time frame: Baseline (diagnosis of COVID-19) to week 6
Ventilator-free Days (VFDs)
Time frame: 6 weeks after diagnosis of COVID-19
Extracorporeal Membrane Oxygenation (ECMO)
Time frame: Baseline (diagnosis of COVID-19) to week 6
Need for Kidney Replacement Therapy
Time frame: Baseline(diagnosis of COVID-19) to week 6
Measurement of Total Comorbidity Burden
Time frame: 6 weeks after diagnosis of COVID-19
Estimate Risk of 30-day Mortality After COVID-19 Infection
Time frame: Baseline (diagnosis of COVID-19) to week 6
Blood Cell Counts at COVID-19 Diagnosis
Time frame: Baseline (Diagnosis of COVID-19)
Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Inflammatory Markers and Kidney Function Tests
Time frame: Baseline (COVID-19 Diagnosis)
Biological Parameters at COVID-19 Diagnosis
Time frame: Baseline(COVID-19 diagnosis)
Cholesterol, Triglyceride and Glucose Levels
Time frame: Baseline(COVID-19 diagnosis)
Red Blood Cell Count
Time frame: Baseline(COVID-19 Diagnosis)
Haemoglobin Levels
Time frame: Baseline(COVID-19 diagnosis)
Haematocrit
Time frame: Baseline (COVID-19 diagnosis)
MCV Levels
Time frame: Baseline(COVID-19 diagnosis)
MCH Levels
Time frame: Baseline(COVID-19 diagnosis)
HbA1C Levels
Time frame: Baseline(COVID-19 diagnosis)
C-reactive Protein Levels
Time frame: Baseline(COVID-19 diagnosis)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Only anonymised summary-format data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection and COVID-19, run by NEAT ID Foundation at 23 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Spain, United Kingdom, France, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From baseline (diagnosis of COVID-19) to Week 6). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.