COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04636671

Marco Confalonieri

Not reported

2020-11-19

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: able to understand and sign the informed consent sars-cov-2 positive on at least one upper respiratory swab or bronchoalveolar lavage pao2 <= 60 mmhg or spo2 <= 90% or on oxygen therapy (any), cpap or nppv at randomization age >= 18 years old at randomization

on invasive mechanical ventilation (either intubated or tracheostomized) heart failure as the main cause of acute respiratory failure on long-term oxygen or home mechanical ventilation decompensated liver cirrhosis immunosuppression (i.e., cancer on treatment, post-organ transplantation, hiv-positive, on immunosuppressant therapy) on chronic steroid therapy or other immunomodulant therapy (e.g., azathioprine, methotrexate, mycophenolate, convalescent/hyperimmune plasma) chronic renal failure with dialysis dependence progressive neuro-muscular disorders cognitively impaired, dementia or decompensated psychiatric disorder quadriplegia/hemiplegia or quadriparesis/hemiparesis do-not-resuscitate order participating in other clinical trial including experimental compound with proved or expected activity against sars-cov-2 infection any other condition that in the opinion of the investigator may significantly impact with patient's capability to comply with protocol intervention refuse to participate in the study or absence of signed informed consent form.

2

University of Trieste

18

100

Italy

Severe disease at enrollment

6: Severe disease at enrollment

690

Survival

None

Phase 3

[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]