Tocilizumab for SARS-CoV2 (COVID-19) Severe Pneumonitis
NCT04315480 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2020-04-13
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-CoV2 infection. Aim of the study is to test the hypothesis that an anti-IL6 treatment can be effective in calming the virus-induced cytokine storm, blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing naso-tracheal intubation and/or death.
Conditions
- SARS Pneumonia
Interventions
- DRUG
-
single intravenous administration 8mg/Kg
Sponsors & Collaborators
-
Azienda Ospedaliera Ospedali Riuniti Marche Nord
collaborator UNKNOWN -
Università Politecnica delle Marche
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-12
- Primary Completion
- 2020-04-09
- Completion
- 2020-05-31
Countries
- Italy
Study Locations
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