Trial NCT04509973
Publication Munch M, JAMA, 2021 (published paper)
Dates: 2020-08-27 to 2021-05-20
Funding: Mixed (This trial was funded by the Novo Nordisk Foundation and supported by the Research Council at Rigshospitalet.)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: quadruple blinding | |
| Location :
Multicenter / Denmark, India, Sweden and Switzerland Follow-up duration (days): 90 | |
| Inclusion criteria | Aged 18 years or older; Hospitalized with confirmed SARS-CoV-2 infection; Required (1) supplementary oxygen at a flow rate of at least 10 L/min (independent of delivery system), (2) noninvasive ventilation or continuous positive airway pressure forhypoxemia, or (3) invasive mechanical ventilation. |
| Exclusion criteria | Treated with systemic glucocorticoids in doses higher than 6 mg of dexamethasone equivalents for indications other than COVID-19; Had been treated with systemic glucocorticoids for COVID-19 for 5 days or longer; Had invasive fungal infection or active tuberculosis; Had known hypersensitivity to dexamethasone; Pregnant patients. |
| Interventions | |
| Treatment
Dexamethasone intermediate dose 12 mg intravenously once a day for up to 10 days |
|
| Control
Dexamethasone Low Dose ( / ) | |
| Participants | |
| Randomized 1000 participants (n1=503 / n2= 497) | |
| Characteristics of participants N=1000 Mean age : NR 677 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=776 Critical: n=206 | |
| Primary outcome | |
| In the register Days alive without life support at day 28 [ Time Frame: Day 28 after randomisation ] Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28 | |
| In the report The number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days. | |
| 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 COVID STEROID 2 trial, comparing lower and higher doses of dexamethasone, was conducted after the early termination of the COVID STEROID trial, which compared glucocorticoids versus placebo and was terminated after the RECOVERY trial reported a reduction in 28-day mortality with low-dose dexamethasone. In addition to the published article, the pre-print article, the registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. There were no substantive differences between the pre-print article and the registry and protocol in population, procedures, interventions or outcomes. Outcomes were registered for 28, 90 and 180 days follow-up, however the published article only reports 28 and 90 days follow-up time. The study achieved its target sample size.
This study was updated on November 9th, 2021 with data from the peer-reviewed journal publication and contact with authors. |