TOFAcitinib in SARS-CoV2 Pneumonia
- Sponsor
- Università Politecnica delle Marche
- Study ID
- NCT04332042
- Phase
- PHASE2
- Status
- Unknown
Conditions
- SARS-COv2 Related Interstitial Pneumonia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tofacitinib — DRUGTofacitinib 10mg twice a day will be administered within 24h from hospital admission for 14 days
Study Details
Immune-mediated lung injury plays a pivotal role in severe interstitial pnemumonia related to SARS-CoV2 infection. Tofacitinib, a JAK1/3-Inhibitor, could mitigate alveolar inflammation by blocking IL-6 signal. The aim of this prospective single cohort open study is to test the hypotesis that early administration of tofacitinib in patients with symptomatic pneumonia could reduce pulmonary flogosis, preventing function deterioration and the need of mechanical ventilation and/or admission in intensive care units.
Key Dates
- Start date
- Apr 10, 2020
- Status verified
- Apr 2020
- Primary completion
- Jun 20, 2020
- Completion
- Jul 10, 2020
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: tofacitinibTofacitinib cp 5mg: 2pills twice a day for 14 days
Primary Outcome Measure
need of mechanical ventilation [ Time Frame: day 14 ]