Status:
TERMINATED
Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19)
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Roche Pharma AG
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief Summary
The mortality rate of the disease caused by the corona virus induced disease (COVID-19) has been estimated to be 3.7% (WHO), which is more than 10-fold higher than the mortality of influenza. Patients...
Detailed Description
Background and Rationale The Acute Respiratory Syndrome by Corona Virus 2 (SARS-CoV-2), first discovered in December 2019 in Wuhan/China, is causing a worldwide pandemic with potentially lethal impli...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04335071
Start Date
April 26 2020
End Date
September 27 2020
Last Update
October 14 2020
Active Locations (4)
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1
University Hospital Bern (Inselspital)
Bern, Switzerland, 3010
2
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
3
Ospedale Regionale di Lugano (EOC)
Viganello, Switzerland, 6962
4
University Hospital Zurich
Zurich, Switzerland, 8091