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

NCT ID: NCT05403359

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2465 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-12-01

Brief Summary

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Steroids

Intervention Type: DRUG

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.

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).

Steroids

Intervention Type: DRUG

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.

Interventions

Steroids

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adult (i.e., ≥18 years)

2. Hospitalized (i.e., admitted to the hospital)

3. Laboratory-confirmed COVID-19 diagnosis (i.e., based on polymerase chain reaction-(PCR) test)

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:

1. Admitted to the ward (e.g., pulmonology ward, COVID-unit, etc.), excluding step-down units.

2. 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:

1. Admitted to the ICU>48 hours.*

2. Invasive mechanical ventilation during ICU stay (intubation with endotracheal tube or tracheostomy) or extracorporeal membrane oxygenation (ECMO).

3. ARDS according to the Berlin criteria

WP4-biobank:

The study population consists of patient subsets admitted to the ICU described in WP2 and WP3.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC

OTHER

Sponsor Role: collaborator

OLVG

NETWORK

Sponsor Role: collaborator

Isala

OTHER

Sponsor Role: collaborator

St. Antonius Hospital

OTHER

Sponsor Role: collaborator

Academisch Ziekenhuis Groningen

OTHER

Sponsor Role: collaborator

Amphia Hospital

OTHER

Sponsor Role: collaborator

Maasstad Hospital

OTHER

Sponsor Role: collaborator

Henrik Endeman

OTHER

Sponsor Role: lead

Responsible Party

Henrik Endeman

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Erasmus MC

Rotterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 37266993 (View on PubMed)

Other Identifiers

10430102110010

Identifier Type: -

Identifier Source: org_study_id