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| Name | Class |
|---|---|
| Amsterdam UMC | OTHER |
| OLVG | NETWORK |
| Isala | OTHER |
| St. Antonius Hospital |
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Rationale: In patients with COVID-19 admitted to the hospital, large heterogeneity exists in patients, timing and dosing of steroid therapy. It is unclear how to treat patients who fail dexamethasone therapy. High-dose steroids are prescribed mainly in patients with the most severe disease, which may be too late given the potential escalation of pathophysiological pathways in these patients.
Objectives: The main objective is to determine the most optimal form, timing and dosing of steroid therapy to reduce the morbidity and mortality of patients admitted to the hospital for COVID-19. This objective will be addressed in 4 work packages (WP):
Study population: Adult patients (≥ 18 years) hospitalized with COVID-19 will be included, more specifically:
Intervention (if applicable): Not applicable (retrospective study design).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Given the retrospective nature of the study, no burden, risks or benefits for the patient are associated with participation. The target population of this study is specific to hospitalized patients with COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ward (e.g., pulmonology ward, COVID-unit, etc.), |
|
| |
| Intensive Care Unit | Adult patients (≥18 years) admitted to the ICU with laboratory-confirmed COVID-19 and acute respiratory distress syndrome (ARDS) according to the Berlin definition criteria (i.e., receiving invasive mechanical ventilation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroids | Drug | Description of the intervention in each of the work packages:
|
| Measure | Description | Time Frame |
|---|---|---|
| 28-day survival (WP2-3) | Alive at day 28 yes/no | Day 28 |
| 28-day need of invasive mechanical ventilation (WP2-3) | Need for mechanical ventilation at day 28 yes/no | Day 28 |
| Need for WHO severity 6-9 (WP1) | WHO clinical progression scale class 6: high flow nasal cannula WHO class 7-9: invasive ventilation | From date of hospital admission up to date of hospital discharge, assessed up to 12 months |
| Hospital mortality in patients who receive HFNC or invasive mechanical ventilation due to restrictions in care (WP1) | Restrictions in care (either on medical grounds or by advance directive of the patient) | From date of hospital admission up to date of hospital discharge, assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| ICU mortality | Death at ICU including date | During ICU stay |
| Hospital mortality | In-hospital death including date | From date of hospital admission up to date of hospital discharge, assessed up to 12 months |
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Inclusion Criteria:
To be eligible for inclusion in any of the work packages, an individual must meet all of the following general inclusion criteria:
WP1A- ward early:
(1) Patients who present with WHO clinical progression scale class 4-5 (no oxygen therapy, Figure 5) when admitted to the ward with COVID-19.
WP1B-ward late:
Admitted to the ward (e.g., pulmonology ward, COVID-unit, etc.), excluding step-down units.
In need of non-invasive oxygen therapy during hospital stay, including:
WP2-ICU admission/ WP3-ICU late:
WP4-biobank:
The study population consists of patient subsets admitted to the ICU described in WP2 and WP3.
Exclusion Criteria:
General exclusion criteria:
Criteria indicated with an asterisk (*) may or may not be applied, depending on data availability. These criteria will be instated if they result in excessive variation of the outcome or exposure, or result in difficulty in generalizing to the target population.
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Adult patients (≥18 years) hospitalized with laboratory-confirmed COVID-19.The (hospitalized) study population is expected to consist mainly of older, male, obese patients who suffer from comorbidities, like hypertension, diabetes mellitus. Around 40% of these patients require invasive mechanical ventilation. The investigators will include patients from all SARS-CoV-2 epidemic waves (including the first wave).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42385526 | Derived | Boyd A, Daenen K, Stoof S, van Willigen HDG, Gommers D, Moeniralam HS, den Uil CA, Juffermans NP, Kant M, Valkenburg AJ, Pillay J, van Gorp E, Schinkel J, van Meenen DMP, Goossen R, Paulus F, Dalm V, Bos LDJ, Endeman H, Huijben JA; PRoVENT- and PRoAcT-COVID Collaborative Group. High-dose corticosteroids are associated with higher mortality in patients with COVID-19 ARDS: Results from a nationwide observational study. J Crit Care. 2026 Jul 1;95:155670. doi: 10.1016/j.jcrc.2026.155670. Online ahead of print. | |
| 41217548 |
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Data will be made available through a secure data transfer system and appropriate data transfer agreement. (The data set contains personal data.)
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Reasonable requests via email (including a protocol describing the research question and data needed) are considered.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013256 | Steroids |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Academisch Ziekenhuis Groningen | OTHER |
| Amphia Hospital | OTHER |
| Maasstad Hospital | OTHER |
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|
| Hospital length of stay | The number of days from the date of hospital admission to date of hospital discharge or death | From date of hospital admission up to date of hospital discharge, assessed up to 12 months |
| ICU length of stay | The number of days from the date of ICU admission to date of ICU discharge or death | During ICU stay |
| Mechanical ventilation duration | Total duration of mechanical ventilation in days | During ICU stay |
| Ventilator free days and alive | Number of ventilator free days at day 28 | Day 28 |
| Rate of respiratory and inflammatory complications during hospital stay | Aspergillus, Herpes simplex virus (HSV),Cytomegalovirus (CMV), Ventilator-associated pneumonia (VAP), Catheter-related bloodstream infection (CRBSI) | From date of hospital admission up to date of hospital discharge, assessed up to 12 months |
| Rate of general systemic complications during hospital stay | Myocardial infarction, deep venous thrombosis, pulmonary embolus, hyperglycemia, hypoglycemia, acute kidney injury, delirium, sepsis | From date of hospital admission up to date of hospital discharge, assessed up to 12 months |
| Derived |
| Daenen K, Rizopoulos D, Dalm VASH, Huijben JA, Stoof SCM, Nagtzaam NMA, Dik WA, Swagemakers SMA, van der Spek PJ, Tong-Minh K, Mersha DGA, Khyali J, Juffermans NP, Gommers D, van Gorp ECM, Bos LDJ, Endeman H. Increasing inflammatory biomarkers are associated with mortality in critically ill COVID-19 patients despite anti-inflammatory treatment. Clin Exp Med. 2025 Nov 11;25(1):361. doi: 10.1007/s10238-025-01904-8. |
| 37266993 | Derived | Daenen K, Huijben JA, Boyd A, Bos LDJ, Stoof SCM, van Willigen H, Gommers DAMPJ, Moeniralam HS, den Uil CA, Juffermans NP, Kant M, Valkenburg AJ, Pillay J, van Meenen DMP, Paulus F, Schultz MJ, Dalm VASH, van Gorp ECM, Schinkel J, Endeman H; PRoVENT- and PRoAcT-COVID Collaborative Group. Optimal Dosing and Timing of High-Dose Corticosteroid Therapy in Hospitalized Patients With COVID-19: Study Protocol for a Retrospective Observational Multicenter Study (SELECT). JMIR Res Protoc. 2023 Jun 2;12:e48183. doi: 10.2196/48183. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |