trial comparing different doses of single-dose tocilizumab in adults with severe COVID-19 infectio

Phase 1

• Conditions: COVID-19 infection; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001767-86-IE
• Lead Sponsor: niversity College Dublin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-15
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified