COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04346355

Massimo Costantini, Ph.D.

massimo.costantini@ausl.re.it

2020-04-15

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - age > 18 years - informed consent for participation in the study - real time polymerase chain reaction (pcr) diagnosis of sars-cov2 infection - hospitalization due to clinical / instrumental diagnosis (high resolution chest ct scan or chest x-ray or pulmonary ultrasound) - presence of acute respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (pao2 / fio2) between 200 and 300 mm/hg - presence of exaggerated inflammatory response defined by the presence of at least 1 of the following criteria: - at least one body temperature measurement >38° c in the past two days; - serum crp greater than or equal to 10 mg/dl; - crp increase of at least twice the basal value

- patients with respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (pao2 / fio2) <200 mm/hg or - patients in non-invasive ventilation or - patients in invasive ventilation or presence of shock or presence of concomitant organ failure that requires admission to the intensive care unit - severe heart and kidney failure - pregnant or breastfeeding patient - patient who, in the opinion of the clinician or by the patient's express will, will not go to intensive care regardless of the evolution of the lung picture. - known hypersensitivity to tcz or its excipients - patient being treated with immuno-depressors or anti-rejection drugs - known active infections or other clinical conditions that contraindicate tcz and cannot be treated or resolved according to the physician's judgment - glutamate-pyruvate transaminase (gpt) or glutamine oxaloacetic transaminase (got) > 5 times the upper limit of the norm - neutrophils <500 /mmc - platelets <50.000 /mmc - diverticulitis or intestinal perforation - suspicion of latent tuberculosis

2

Azienda Unità Sanitaria Locale Reggio Emilia

18

None

Italy

Severe disease at enrollment

6: Severe disease at enrollment

126

Entry into Intensive Care with invasive mechanical ventilation or death from any cause or clinical aggravation

None

Phase 2

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]