COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04335071

Peter M. Villiger

peter.villiger@insel.ch

2020-04-06

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: i (first step): - admission to hospital - male or non-pregnant female, ≥60 years of age or ≥30 years of age plus one or more known risk factors (arterial hypertension, diabetes mellitus, coronary heart disease, heart failure, pre-existing chronic pulmonary disease) - confirmed sars-cov infection - radiographic evidence compatible with covid-19 pneumonia (x-ray/ct scan, etc.) - signed informed consent form ii (second step; indication for intervention): - crp ≥50mg/l plus 3 out of the following 5 criteria need to be fulfilled: - respiration rate ≥25 - spo2 <93% (on ambient air) - pao2 <65 mmhg - persistent or increasing dyspnoea as defined by a one point increase on the mmrc dyspnoea scale (over 1 hour) - persistent or increasing oxygen demand (over 1 hour)

i (first step): - patients >80 years of age - patient included in any other interventional trial - indication for imminent or immediate transfer to icu - treatment with tcz (or other anti-il-6r treatment) within 4 weeks prior to baseline - uncontrolled bacterial superinfection according to investigator - history of severe allergic reaction to tcz - history of diverticulitis requiring antibiotic treatment or history of colon perforation - history of primary immunodeficiency (e.g. cvid) or progressing malignancy - history of chronic liver disease (>child-pugh a, or according to investigator) ii (second step; contraindication for intervention): - alanine transaminase/aspartate transaminase (alt/ast) >5 times of the upper limit of normal - hemoglobin <80 g/l - leukocytes <2.0 g/l - absolute neutrophil count <1.0 g/l - platelets <50 g/l

2

Insel Gruppe AG, University Hospital Bern

30

80

Switzerland

Severe disease at enrollment

6: Severe disease at enrollment

5

Number of patients with ICU admission;Number of patients with death;Number of patients with intubation

None

Phase 2

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]