NCT05403359

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,465 (actual)
• Sponsor: Henrik Endeman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-06-03
• Last updated: 2025-04-09

Locations

1 site across 1 country: Netherlands