Baricitinib Compared to Standard Therapy in Patients With COVID-19

• Status: Not yet recruiting
• Trial end date: 2020-07-30
• Target enrollment: 0
• Participant gender: All

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 respiratory disease, because of its immunomodulating and hypothesized antiviral activity.

This is a multicenter randomized clinical trial that aims to evaluate the efficacy and safety of baricitinib in patients with SARS-CoV2 pneumonia. Patients will be randomized to receive or not baricitinib as adjunctive therapy. All patients will continue to receive the ongoing standard therapy: chloroquine/idrossichloroquine and low-molecular weight heparin (LMWH) eventually associated with ritonavir/lopinavir or darunavir/ritonavir will be allowed for all included patients.

The primary endpoint measure is the efficacy of baricitinib in reducing the number of patients requiring invasive ventilation after 7 and 14 days of treatment.

Secondary endpoints will be mortality rates and toxicity of baricitinib.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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