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Publication Perner A, unpublished, 2020 ( )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 criteria | Aged 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 criteria | use 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/day in 104ml or 50mg in 10 ml) Co-Intervention: Standard care Duration : 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. |