COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001767-86/IE

University College Dublin - QRAM

crc.monitoring@ucd.ie

2020-04-15

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Confirmed SARS-CoV2 infection (as defined by positive PCR) Evidence of hyper inflammatory state as evidenced by at least three of the following: o Documented temperature >38°C in the past 48 hours o IL6 >40 pg/ml, or in its absence D-dimer >1.5 μgFEU /ml. o Elevated CRP (>100mg/L) and/or a three-fold increase since presentation o Elevated ferritin X5 ULN o Elevated LDH (above the ULN) o Elevated fibrinogen (above the ULN) Pulmonary infiltrates on chest imaging Moderate to severe respiratory failure as defined by PaO2/FiO2≤300mmHg Aged 18 years or older

Primary or secondary immunodeficiency Use of significant immunosuppressive therapy in the last 3 months (not including hydroxychloroquine or short course of corticosteroids (defined as <400mg cumulative dose) Active malignancy requiring treatment Known active current or history of recurrent bacterial, mycobacterial, fungal or viral infections including history of untreated latent TB History of diverticulitis or chronic ulcerative GI disease that might predispose to GI perforation Severe allergic reaction to monoclonal antibodies Pregnancy or breast feeding AST / ALT with values greater than 10 times normal levels or history of significant liver disease that in the opinion of the investigator precludes use of an investigational agent Neutrophils < 0.5 x109/L Platelets < 50x109/L Documented, uncontrolled sepsis caused by pathogen(s) other than COVID-19 Presence of co-morbidities (including cognitive impairment and/or frailty) that, in the opinion of the investigator, should preclude use of an investigational agent Current skin or soft tissue infection not controlled by antibiotics Body weight ≤ 30kg

3

University College Dublin

18

100

Ireland

Severe disease at enrollment

6: Severe disease at enrollment

90

Proportion of subjects at day 8 who have reached a composite primary endpoint of progression to intubation and ventilation, non-invasive ventilation or death

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

[{"arm_notes": "4mg/kg", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "8mg/kg", "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"}]