COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04325061

Jesús Villar, MD

jesus.villar54@gmail.com

2020-03-27

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

- 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.

2

Dr. Negrin University Hospital

18

None

Spain

Severe disease at enrollment

6: Severe disease at enrollment

19

60-day mortality

None

Phase 4

[{"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]