COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001854-23/IT

AOUI VERONA - Malattie Infettive

evelina.tacconelli@univr.it

2020-06-26

Terminated

RCT

Randomized

Adaptive

Open label

multi-center

Treatment

Adults aged >= 18 years able to provide a valid informed consent to the study Documented COVID-19 according to local requirements, with pneumonia at imaging (Chest-X ray or CT) High inflammation, one of the following: ¿ CRP > 6 times UNL ¿ D-dimer > 1500 ng/ml PaO2/FiO2 250-400 mmHg Adulti >= 18 anni in grado di fornire un valido consenso alla partecipazione allo studio COVID-19 documentata secondo le line guida locali, con polmonite documentata all’imaging (Rx-torace or TC) Stato infiammatorio, uno fra: ¿ PCR > 6 volte UNL ¿ D-dimero > 1500 ng/ml PaO2/FiO2 >400-250 mmHg

Orotracheal intubation or ECMO support Active solid / hematologic cancer (including invasive non-melanoma skin cancer) Hypersensitivity or contra-indications to one of the investigational agents (including history of deep vein thrombosis / pulmonary thromboembolism or diverticulitis) Other active concurrent viral, fungal or bacterial infections (including active tuberculosis, HIV and HCV/HBV infections) Pregnancy/breastfeeding Incapability to provide a valid informed consent (including age < 18 years old) Heart failure with NYHA >= 2 or any acute cardiac or vascular event requiring therapy in the previous 12 months Chronic renal failure (baseline GFR < 45 ml/min*1.73m2) Liver cirrhosis moderate / severe (Child-Pugh B or C) Chronic respiratory failure requiring O2 therapy or ventilation therapy at home Blood neutrophils <500/mcL, platelet <50000/mcL, Hb levels <80 g/ ALT/AST > 5 times UNL Use of any biologic agent or small molecule inhibitor and other investigational drugs in the previous 3 months (or 5 half-lives) Use of other immunosuppressive agents in the last 3 months Any other condition judged by the local investigator as a contra-indication to eligibility Intubazione orotracheale o ECMO Tumori maligni solidi o ematologici attivi (incluso tumori cutanei invasivi) Ipersensibilità o contro-indicazione a uno dei farmaci (inclusa la storia di tromboembolismo venoso o diverticolite) Altre infezioni attive di natura virale, fungine o batteriche (incluso tubercolosi attiva, HIV e HCV/HBV) Gravidanza ed allattamento Incapacità a provvedere un valido consenso informato Scompenso cardiaco di classe NYHA >= 2 o qualsiasi evento cardiaco o cardiovascolare richiedente terapia nei precedenti 12 mesi. Insufficienza renale cronica (GFR al baseline <45 ml/min*1.73m2) Cirrosi epatica moderata/severa (Child-Pugh B o C) Insufficienza respiratoria cronica necessitante ossigenoterapia o ventiloterapia al domicilio Neutrofili ematici <500/mcL, piastrine <50000/mcL, Hb <80 g/ ALT/AST > 5 volte UNL Utilizzo di qualsiasi terapia biologica o piccolo molecole inibitori, and nei precedenti 3 mesi (o 5 emivite) Altre terapie immunosoppressive nei precedenti 3 mesi Qualsiasi condizione giudicata dallo Sperimentatore locale giudicata come una contra-indicazione all’eleggibilità

7

SOCIETA' ITALIANA MALATTIE INFETTIVE E TROPICALI

18

100

Italy

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

1400

Proportion of patients with PaO2/FiO2 <200 mmHg at day 10 in each intervention arm as compared to the control arm Frazione di pazienti con PaO2/FiO2 <200 mmHg al girono 10 in ogni braccio interventistico rispetto al braccio controllo

nan

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1544, "treatment_name": "Baricitinib+hydroxychloroquine", "treatment_type": "Kinase inhibitors+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1578, "treatment_name": "Hydroxychloroquine+tocilizumab", "treatment_type": "Antimalarials+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1572, "treatment_name": "Hydroxychloroquine+sarilumab", "treatment_type": "Antimalarials+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1573, "treatment_name": "Hydroxychloroquine+siltuximab", "treatment_type": "Antimalarials+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1547, "treatment_name": "Canakinumab+hydroxychloroquine", "treatment_type": "Interleukin inhibitors+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1566, "treatment_name": "Hydroxychloroquine+methylprednisolone", "treatment_type": "Antimalarials+corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]