Status:
UNKNOWN
Tocilizumab for SARS-CoV2 (COVID-19) Severe Pneumonitis
Lead Sponsor:
Università Politecnica delle Marche
Collaborating Sponsors:
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Conditions:
SARS Pneumonia
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
In a Phase 2 Simon's Optimal Two-Stages Design intravenous tocilizumab will be administered as single 8mg/Kg dose in patients affected by severe multifocal interstitial pneumonia correlated to SARS-Co...
Eligibility Criteria
Inclusion
- SARS-CoV2 Infection diagnosed by rt-PCR
- CT-scan confirmed multifocal interstitial pneumonia
- Need of oxygen therapy to maintain SO2\>93%
- Worsening of lung involvement, defined as (one of the following criteria):
- Worsening of oxygen saturation \>3 percentage points or decrease in PaO2 \>10%, with stable FiO2 in the last 24h
- Need of increase FiO2 in order to maintain a stable SO2 or new onset need of mechanical ventilation in the last 24h
- Increase in number and/or extension of pulmonary areas of consolidation
Exclusion
- Age \<18 ys and \>90 ys
- Severe heart failure
- Bacterial Infection
- Haematological neoplasm
- Neutrophil count below 1000/mcl
- Platelet count below 50000/mcl
- ALT\> x5UNL
- Inability to give informed consent
Key Trial Info
Start Date :
March 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04315480
Start Date
March 12 2020
End Date
May 1 2020
Last Update
April 13 2020
Active Locations (1)
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1
Università Politecnica delle Marche
Ancona, AN, Italy, 60020