COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04331808

Assistance Publique - Hôpitaux de Paris

Not reported

2020-04-02

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: patients included in the corimuno-19 cohort patients belonging to one of the 2 following groups: group 1: cases meeting all of the following criteria requiring more than 3l/min of oxygen oms/who progression scale = 5 no niv or high flow group 2: cases meeting all of the following criteria respiratory failure and (requiring mechanical ventilation or niv or high flow) who progression scale >=6 no do-not-resuscitate order (dnr order)

- patients with exclusion criteria to the corimuno-19 cohort. - known hypersensitivity to tocilizumab or to any of their excipients. - pregnancy - current documented bacterial infection - patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication: - absolute neutrophil count (anc) ≤ 1.0 x 109/l - haemoglobin level: no limitation - platelets (plt) < 50 g /l - sgot or sgpt > 5n

2

Assistance Publique - Hôpitaux de Paris

18

None

France

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

228

Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14. Group 2.;WHO progression scale <=5 at day 4. Group 1.;Survival without needs of ventilator utilization at day 14. Group 1;WHO progression scale at day 4. Group 2.

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"}]