COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04673162

Massimo Costantini

not reported

2020-12-17

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: age = 18 years; informed consent for participation in the study and for data processing; molecular diagnosis with polymerase chain reaction (pcr) test of sars-cov2 infection; hospitalization in a specialist ward for covid-19 patient care (eg., infectious diseases, pulmonology or internal medicine); need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation; pao2 / fio2 between 100 and 300 mmhg. clinical / instrumental diagnosis (high resolution chest ct scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days; serum crp greater than 5 mg / dl; interval from onset of sars-cov2 infection symptoms to randomization> 5 days-

invasive mechanical ventilation; presence of shock or concomitant organ failure that requires admission to the intensive care unit; pregnancy or breastfeeding; severe heart or kidney failure; known hypersensitivity to methylprednisolone, to dexamethasone or to an exception; diabetes not compensated according to the doctor's judgment; other clinical conditions that contraindicate methylprednisolone and cannot be treated or resolved according to the doctor's judgment; steroid bolus therapy in the week prior to enrollment for the study; enrollment in another clinical trial; patient already randomized in this study-

2

Azienda Unità Sanitaria Locale Reggio Emilia

18

100

Italy

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

260

Length of hospitalization

None

Phase 3

[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]