Trial NCT04348305
Publication Munch MW, Acta Anaesthesiol Sc, 2021 (published paper)
Dates: 2020-04-17 to 2020-06-16
Funding: Mixed (Novo Nordisk Foundation, Rigshospitalet's Research Council, and Pfizer.)
Conflict of interest: No
| Methods | |
| RCT Blinding: quadruple blinding | |
| Location :
Multicenter / Denmark Follow-up duration (days): 90 | |
| Inclusion criteria | Age ≥18 years; confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation; 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 oygen supplementation with an oxygen flow of at least 10L.min independent of delivery system |
| Exclusion criteria | Use of systemic corticosteroids; Invasive mechanical ventilation >48 hours prior to screening; 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 per day either as continuous infusion or as bolus injections every 6 hours (50 mg per bolus) for 7 days or until hospital discharge (whichever came first). |
|
| Control
Placebo | |
| Participants | |
| Randomized 30 participants (n1=16 / n2= 14) | |
| Characteristics of participants N=30 Mean age : NR 24 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=19 Critical: n=11 | |
| Primary outcome | |
| In the register Days alive without life support at day 28 [Time Frame: Day 28 after randomisation] | |
| In the report Days alive without the use of life support (i.e. invasive mechanical ventilation, circulatory support, or renal replacement therapy, including days in between intermittent renal replacement therapy) at day 28 | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated
|
| 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 | In addition to the published article, the original and published protocols, statistical analysis plan, registries (EudraCT 2020-03-30; NCT submitted 2020-04-14) and supplementary appendices were used in data extraction and assessment of risk of bias. The primary outcome indicated in registry reflects the primary outcome reported in the paper. Long-term outcomes in the registry (all-cause mortality and health-related quality of life at 1 year) are not reported in this article. The study was terminated after 30 patients were enrolled due to low recruitment. The trial was terminated due to information from the RECOVERY trial and from a WHO-initiated meta-analysis of ongoing or recently completed trials demonstrating benefit from systemic corticosteroids on 28-day mortality in critically ill patients with COVID-19. The planned sensitivity analyses could not be completed because of low sample size. The study did not achieve the target sample size. |