Trial NCT04348305
Publication Perner A, Unpublished, 2020 ( )

Funding: Mixed (Rigshospitalet's Research Council, Novo Nordisk Fonden,Pfizer)
Conflict of interest: Yes

Methods
RCT
Blinding: quadruple blinding
Location : Multicenter / Denmark
Follow-up duration (days): 365
Inclusion criteriaAged 18 years or above AND Confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation AND Use of one of the following: Invasive mechanical ventilation OR Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system
Exclusion criteriause of systemic corticosteroids for any other indication than COVID-19 Invasive mechanical ventilation for more than 48 hours Invasive fungal infection Fertile woman (< 60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG Known hypersensitivity to hydrocortisone A patient for whom the clinical team has decided not to use invasive mechanical ventilation Previously randomised into the COVID STEROID trial Informed consent not obtainable
Interventions
Treatment
Hydrocortisone
200 mg once a day (or 50mg 4 times a day) IV infusion for 7 days
Control
Placebo (matching isotonic saline(0.9%) in 104 ml)
Duration : 7 days
Participants
Randomized
29 participants (n1=15 / n2= 14)
Characteristics of participants
N=29
Mean age : NR
23 males
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=14 Critical: n=15
Primary outcome
In the register
Days alive without life support at day 28 [ Time Frame: Day 28 after randomisation ]
In the report
NR
Documents
avalaible

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Low
General comment The study is not published yet. Data presented was extracted from study registry, protocol and Sterne, Jonathan AC, et al. "Association between Administration of Systemic Corticosteroids and Mortality among critically ill patients with COVID-19: a meta-analysis." Jama (2020). The authors have been contacted in order to obtain the results.