Trial NCT04325061
Publication Villar J, Unpublished, 2020 ( )
Funding: Public/non profit (Instituto de Salud Carlos III, Madrid, Spain(CB06/06/1088, PI19/00141); Asociación Científica Pulmón y VentilaciónMecánica, Las Palmas de Gran Canaria, Spain; and the Canadian Institute for Health Research, Ottawa, Canad)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Spain Follow-up duration (days): 60 | |
| Inclusion criteria | Age 18 years or older; Positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for COVID-19 in a respiratory tract sample; Intubated and mechanically ventilated; Acute onset of ARDS, as defined by Berlin criteria as moderate-to-severe ARDS,3 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension, pulmonary capillary wedge pressure <18 mmHg, or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ratio of ≤200 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2. |
| Exclusion criteria | Routine treatment with corticosteroids during the previous week irrespective of dose; Corticosteroid use within the previous 24 h of more than 20 mg of dexamethasone or equivalent; Patients with a known contraindication to corticosteroids; Decision by a physician that involvement in the trial is not in the patient's best interest; Pregnancy and breast-feeding; Participation in another therapeutic trial. |
| Interventions | |
| Treatment
Dexamethasone 20mg IV once a day for 5 days and then 10mg IV once a day for 5 days |
|
| Control
Standard care Definition of Standard care: Standard intensive care | |
| Participants | |
| Randomized 19 participants (n1=7 / n2= 12) | |
| Characteristics of participants N=19 Mean age : NR 13 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=19 | |
| Primary outcome | |
| In the register 60-day mortality [ Time Frame: 60 days ] | |
| 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. |