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Publication Villar J, unpublished, 2020 ( )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/day day 1-5. 10mg/day day 6-10) Co-Intervention: Standard care Duration : 10 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 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. |