Status:
UNKNOWN
Baricitinib Compared to Standard Therapy in Patients With COVID-19
Lead Sponsor:
Azienda Ospedaliero, Universitaria Pisana
Conditions:
Covid-19
SARS-CoV 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
There is urgent need of an effective therapy for Covid-19. To date, the best treatment of SARS-CoV-2 infection is unknown. Baricitinib has been identified as potential treatment for 2019-nCoV acute re...
Detailed Description
There is urgent need of an effective therapy for Covid-19. To date, the best treatment of SARS-CoV-2 infection is unknown. Multiple strategies have been proposed and several randomized clinical trials...
Eligibility Criteria
Inclusion
- Any gender
- Age \> 18 years on day of signing informed consent
- Informed written consent for participation in the study
- Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- Hospitalized due to clinical instrumental diagnosis of pneumonia.
- Oxygen saturation at rest in ambient air ≤93% or P/F ratio \<250
- Able to be administered by oral route drugs
- Patients who receive O2 therapy or who need non-invasive mechanical ventilation
- In case of female patients at childbearing potential, they should agree to use highly effective methods of birth control at least till 7 days after the termination of the treatments
Exclusion
- Known hypersensitivity to Baricitinib or its excipients
- Patients with Creatinine Clearance \< 30 ml/min
- Patients with active Tuberculosis (TBC)
- Patients with known HBV or HCV infection
- Patients with deep vein thrombosis (DVP) or Pulmonary Embolism (PE)
- Patients with ALT or AST\> 5 times the upper limit of the normality
- Neutrophils \<1000/mmc
- Platelets \<50.000/mmc
- Hb\< 8g/dl
- Bowel diverticulitis or perforation
- Patients who receive invasive mechanical ventilation
- Documented bacterial infection at time of randomization
- Patients with "do not resuscitate order"
- Patients receiving immunosuppressants or anti-rejection drugs
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2020
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04393051
Start Date
May 20 2020
End Date
July 30 2020
Last Update
May 20 2020
Active Locations (1)
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1
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126