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Publication Perner A, Unpublished, 2020 ( )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 once a day (or 50mg 4 times a day) IV infusion for 7 days |
|
Control
Placebo 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 available |
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. |