Status:
COMPLETED
StEroids in hospitaLized patiEnts With Covid-19 in The Netherlands.
Lead Sponsor:
Henrik Endeman
Collaborating Sponsors:
Amsterdam UMC
OLVG
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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:
- (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:
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
2465 Patients enrolled
Trial Details
Trial ID
NCT05403359
Start Date
June 1 2022
End Date
December 1 2023
Last Update
April 9 2025
Active Locations (1)
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1
Erasmus MC
Rotterdam, Netherlands