COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04341870

Assistance Publique - Hôpitaux de Paris

Not reported

2020-04-10

Suspended

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - patients included in the corimuno-19 cohort (nct04324047) - covid-19 cases not requiring icu at admission with moderate or severe pneumopathy according to the who criteria of severity of covid pneumopathy: - moderate cases: cases meeting all of the following criteria: [showing fever and respiratory symptoms with radiological findings of pneumonia] and [requiring between 3l/min and 5l/min of oxygen to maintain spo2>97%] or - severe cases: cases meeting any of the following criteria: [respiratory distress ( ≥ 30 breaths/ min)] or [oxygen saturation≤93% at rest in ambient air; or oxygen saturation ≤97 % with o2 > 5l/min] or [pao2/fio2 ≤ 300mmhg]

patients with exclusion criteria to the corimuno-19 cohort. respiratory failure requiring non invasive or mechanical ventilation patients requiring intensive care do-not-resuscitate order (dnr order) known hypersensitivity to sarilumab or to any of their excipients. known contra-indication to hydroxychloroquine or chloroquine: including hypersensitivity/allergy, retinopathy, g6pd deficiency and qt prolongation known contra-indication to azithromycin: including hypersensitivity/allergy and qt prolongation pregnancy or breastfeeding 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

80

France

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

27

Need for ventilation (including invasive and non invasive ventilation), intensive care or death

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1541, "treatment_name": "Azithromycin+hydroxychloroquine+sarilumab", "treatment_type": "Antibiotics+antimalarials+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1148, "treatment_name": "Sarilumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]