COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04357808

Rosario Garcia de Vicuña

mariadelrosario.garcia@salud.madrid.org

2020-04-22

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: age> 18 years laboratory-confirmed sars-cov-2 infection as determined by pcr or other validated commercial or public health assay documented interstitial pneumonia requiring admission and at least two of the following: fever ≥ 37.8ºc (tympanic) il-6 in serum ≥ 25 ng / ml (in the absence of a previous dose of prednisone or equivalent> 1 mg / kg) or pcr> 5mg / dl lymphocytes <600 mm3 ferritin> 300 mcg / l that doubles in 24 hours ferritin> 600 mcg / l in the first determination and ldh> 250 u / l d-dimer (> 1 mg / l) informed verbal or administration consent under urgent conditions, documented in the electronic medical record.

- patients who require mechanical ventilation at the time of inclusion. - ast / alt values > 5 folds upper normal limit. - neutrophil count below 500 cells / mm3 - platelet count below 50,000 cells / mm3 - documented sepsis or high suspicion by pathogens other than covid-19. - presence of comorbidities that according to clinical judgment could lead to an unfavorable result. - complicated diverticulitis or intestinal perforation. - current skin infection (eg, uncontrolled dermopiodermitis). - immunosuppressive anti-rejection therapy. - pregnancy or lactation. - previous treatment with tocilizumab or sarilumab. - patients participating in some other clinical trial for sars-cov-2 infection. - patients with known hypersensitivity or contraindication to sarilumab or excipients.

2

Maria del Rosario Garcia de Vicuña Pinedo

18

None

Spain

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

30

Death;Duration of hospitalisation (days);Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation

None

Phase 2

[{"arm_notes": "", "treatment_id": 1148, "treatment_name": "Sarilumab", "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"}]