Tocilizumab for SARS-CoV2 (COVID-19) Severe Pneumonitis
- Sponsor
- Università Politecnica delle Marche
- Study ID
- NCT04315480
- Phase
- PHASE2
- Status
- Unknown
Conditions
- SARS Pneumonia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tocilizumab — DRUGsingle intravenous administration 8mg/Kg
Study Details
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.
Key Dates
- Start date
- Mar 12, 2020
- Status verified
- Apr 2020
- Primary completion
- Apr 9, 2020
- Completion
- May 31, 2020
Study Design
- Enrollment
- 38 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: tocilizumab
Primary Outcome Measure
arrest in deterioration of pulmonary function [ Time Frame: 7days ]