COVID-19SELECTNCT05403359

StEroids in hospitaLized patiEnts With Covid-19 in The Netherlands.

An observational study of COVID-19, run by Henrik Endeman at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Steroids
How many people: 2,465 participants
Where: 1 siteNetherlands
Study dates: 1 Jun 2022to 1 Dec 2023
Phase: Observational
Are there results?: None posted in the registry

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: 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).

Who may be able to join

To be eligible for inclusion in any of the work packages, an individual must meet all of the following general inclusion criteria:
Adult (i.e., ≥18 years)
Hospitalized (i.e., admitted to the hospital)
Laboratory-confirmed COVID-19 diagnosis (i.e., based on polymerase chain reaction-(PCR) test)
WP1A- ward early:
Patients who present with WHO clinical progression scale class 4-5 (no oxygen therapy, Figure 5) when admitted to the ward with COVID-19.

Show all 21Show fewer

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:
Conventional oxygen therapy (COT) 1-5 L/min
Conventional oxygen therapy (COT) 6-12 L/min
Non-rebreather mask 12-15 L/min
High-flow nasal cannula 16-60 L/min
Non-invasive continuous positive airway pressure (CPAP)
Non-invasive bilevel positive airway pressure (BiPAP)
WP2-ICU admission/ WP3-ICU late:
Admitted to the ICU>48 hours.*
Invasive mechanical ventilation during ICU stay (intubation with endotracheal tube or tracheostomy) or extracorporeal membrane oxygenation (ECMO).
ARDS according to the Berlin criteria
WP4-biobank:
The study population consists of patient subsets admitted to the ICU described in WP2 and WP3.

Who cannot join

General exclusion criteria:
Mortality within 48 hours.*
Opt-out (objection to participate)
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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Erasmus MC
Rotterdam

Other trials in Netherlands

About this study

Official title: Optimal Dosing and Timing of Corticosteroids in Hospitalized Patients With COVID-19.

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):

WP-1A-ward admission: What is the effect of higher dose steroids upon hospital admission on clinical deterioration and what would be the optimal timing of increasing steroid dosage?
WP1B-ward late: Do high-dose steroids, compared to no steroids, improve outcomes in dexamethasone-unresponsive COVID-19 patients on the ward after dexamethasone 6 mg/day for 10 days?
WP2-ICU admission: Do high-dose steroids, compared to 6 mg/day dexamethasone or its equivalent, improve outcomes in patients admitted to the ICU with moderate/severe C-ARDS?
WP3-ICU late: Do high-dose steroids, compared to no steroids, improve outcomes in ICU patients with moderate/severe C-ARDS after dexamethasone 6 mg/day for 10 days?
WP4-biobank: Can biomarkers help predict outcomes after (high dosed) steroid therapy? Study design: Retrospective observational multicenter study in the Netherlands.

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.

Conditions: COVID-19
Being tested: Steroids
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SteroidsDrug
Description of the intervention in each of the work packages:
- WP1A admission: Steroid dose >6mg/day dexamethasone equivalent will be compared to control (steroid = 6mg/day dexamethasone or equivalent steroid).
- WP1B late: After 10 days of dexamethasone therapy patients are stratified in high-dose steroids (> 6 mg dexamethasone or equivalent steroid) or no steroids up to day 28.
- WP2 ICU admission: High-dose steroids (dexamethasone >6 mg daily or equivalent corticosteroids) compared to dexamethasone 6 mg up to 72 hours after admission
- WP3 ICU late: After dexamethasone 6 mg for 10 days patients are stratified in high-dose steroids (dexamethasone >6 mg daily or equivalent corticosteroids) or no steroids up to day 28.

Study groups in NCT05403359
Study group	Role	What they receive
Ward (e.g., pulmonology ward, COVID-unit, etc.),		* WP1A: Patients with WHO clinical progression scale class 4-5 (i.e., no oxygen therapy) admitted to the ward with laboratory-confirmed COVID-19. * WP1B: Adult patients admitted to the ward with laboratory-confirmed COVID-19 and on at least oxygen therapy. Receives: Drug: Steroids
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). Receives: Drug: Steroids

What is being measured

The primary outcome is the main question the study is designed to answer.

28-day survival (WP2-3)
Alive at day 28 yes/no
Measured: Day 28
28-day need of invasive mechanical ventilation (WP2-3)
Need for mechanical ventilation at day 28 yes/no
Measured: 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
Measured: 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)
Measured: From date of hospital admission up to date of hospital discharge, assessed up to 12 months

Secondary outcomes (8)

ICU mortality
Death at ICU including date
Measured: During ICU stay
Hospital mortality
In-hospital death including date
Measured: From date of hospital admission up to date of hospital discharge, assessed up to 12 months
Hospital length of stay
The number of days from the date of hospital admission to date of hospital discharge or death
Measured: 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
Measured: During ICU stay
Mechanical ventilation duration
Total duration of mechanical ventilation in days
Measured: During ICU stay
Ventilator free days and alive
Number of ventilator free days at day 28
Measured: 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)
Measured: 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
Measured: From date of hospital admission up to date of hospital discharge, assessed up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20221 Dec 2023

First posted3 Jun 2022
Study start1 Jun 2022
Primary completion1 Dec 2023
Study completion1 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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: Cohort
Time perspective: Retrospective
Enrolment: 2,465 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05403359
Sponsor's protocol ID: 10430102110010
Acronym: SELECT
Status last verified: Apr 2025
First submitted: 1 Jun 2022
Last updated: 9 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be made available through a secure data transfer system and appropriate data transfer agreement. (The data set contains personal data.)

Publications

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 Oct;95:155670. doi: 10.1016/j.jcrc.2026.155670. Epub 2026 Jul 1.
PubMed 42385526
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.
PubMed 41217548
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.
PubMed 37266993

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimal Dosing and Timing of Corticosteroids in Hospitalized Patients With COVID-19.
ClinicalTrials.gov ID: NCT05403359
Acronym / sponsor ID: SELECT / 10430102110010
Conditions: COVID-19
Study type: Observational
Recruitment status: Completed
Enrolment: 2,465 participants (actual)
Lead sponsor: Henrik EndemanUniversity, hospital or other
Collaborators: Amsterdam UMC, OLVG, Isala, St. Antonius Hospital, Academisch Ziekenhuis Groningen, Amphia Hospital, Maasstad Hospital
Study start: 1 Jun 2022 (actual)
Primary completion: 1 Dec 2023 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 3 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

WP-1A-ward admission: What is the effect of higher dose steroids upon hospital admission on clinical deterioration and what would be the optimal timing of increasing steroid dosage?
WP1B-ward late: Do high-dose steroids, compared to no steroids, improve outcomes in dexamethasone-unresponsive COVID-19 patients on the ward after dexamethasone 6 mg/day for 10 days?
WP2-ICU admission: Do high-dose steroids, compared to 6 mg/day dexamethasone or its equivalent, improve outcomes in patients admitted to the ICU with moderate/severe C-ARDS?
WP3-ICU late: Do high-dose steroids, compared to no steroids, improve outcomes in ICU patients with moderate/severe C-ARDS after dexamethasone 6 mg/day for 10 days?
WP4-biobank: Can biomarkers help predict outcomes after (high dosed) steroid therapy? Study design: Retrospective observational multicenter study in the Netherlands.

Study population: Adult patients (≥ 18 years) hospitalized with COVID-19 will be included, more specifically:

Intervention (if applicable): Not applicable (retrospective study design).

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Ward (e.g., pulmonology ward, COVID-unit, etc.),	–	Drug: Steroids* WP1A: Patients with WHO clinical progression scale class 4-5 (i.e., no oxygen therapy) admitted to the ward with laboratory-confirmed COVID-19. * WP1B: Adult patients admitted to the ward with laboratory-confirmed COVID-19 and on at least oxygen therapy.
Intensive Care Unit	–	Drug: SteroidsAdult 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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).

Key inclusion criteria (21 listed)

To be eligible for inclusion in any of the work packages, an individual must meet all of the following general inclusion criteria:
Adult (i.e., ≥18 years)
Hospitalized (i.e., admitted to the hospital)
Laboratory-confirmed COVID-19 diagnosis (i.e., based on polymerase chain reaction-(PCR) test)
Patients who present with WHO clinical progression scale class 4-5 (no oxygen therapy, Figure 5) when admitted to the ward with COVID-19.

Key exclusion criteria (4 listed)

Mortality within 48 hours.*
Opt-out (objection to participate)
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.

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
SteroidsDescription of the intervention in each of the work packages: * WP1A admission: Steroid dose >6mg/day dexamethasone equivalent will be compared to control (steroid = 6mg/day dexamethasone or equivalent steroid). * WP1B late: After 10 days of dexamethasone therapy patients are stratified in high-dose steroids (> 6 mg dexamethasone or equivalent steroid) or no steroids up to day 28. * WP2 ICU admission: High-dose steroids (dexamethasone >6 mg daily or equivalent corticosteroids) compared to dexamethasone 6 mg up to 72 hours after admission * WP3 ICU late: After dexamethasone 6 mg for 10 days patients are stratified in high-dose steroids (dexamethasone >6 mg daily or equivalent corticosteroids) or no steroids up to day 28.	Drug	Intensive Care Unit, Ward (e.g., pulmonology ward, COVID-unit, etc.),

Primary outcome

28-day survival (WP2-3)
Time frame: Day 28
Alive at day 28 yes/no
28-day need of invasive mechanical ventilation (WP2-3)
Time frame: Day 28
Need for mechanical ventilation at day 28 yes/no
Need for WHO severity 6-9 (WP1)
Time frame: From date of hospital admission up to date of hospital discharge, assessed up to 12 months
WHO clinical progression scale class 6: high flow nasal cannula WHO class 7-9: invasive ventilation
Hospital mortality in patients who receive HFNC or invasive mechanical ventilation due to restrictions in care (WP1)
Time frame: From date of hospital admission up to date of hospital discharge, assessed up to 12 months
Restrictions in care (either on medical grounds or by advance directive of the patient)

8 secondary outcomes

ICU mortality
Time frame: During ICU stay
Hospital mortality
Time frame: From date of hospital admission up to date of hospital discharge, assessed up to 12 months
Hospital length of stay
Time frame: From date of hospital admission up to date of hospital discharge, assessed up to 12 months
ICU length of stay
Time frame: During ICU stay
Mechanical ventilation duration
Time frame: During ICU stay
Ventilator free days and alive
Time frame: Day 28
Rate of respiratory and inflammatory complications during hospital stay
Time frame: From date of hospital admission up to date of hospital discharge, assessed up to 12 months
Rate of general systemic complications during hospital stay
Time frame: From date of hospital admission up to date of hospital discharge, assessed up to 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
Derived from this study: PubMed 42385526Boyd 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 Oct;95:155670. doi: 10.1016/j.jcrc.2026.155670. Epub 2026 Jul 1.
Derived from this study: PubMed 41217548Daenen 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.
Derived from this study: PubMed 37266993Daenen 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.
Individual participant dataSharing planned: Yes. 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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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Henrik Endeman at 1 site in Netherlands.

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 21 inclusion and 4 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 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

28-day survival (WP2-3) (time frame: Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05403359, which also lists 3 linked publications.

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 9 Apr 2025.