Status:

COMPLETED

Baricitinib Therapy in COVID-19

Lead Sponsor:

Fabrizio Cantini

Conditions:

COVID

Pneumonia

Eligibility:

All Genders

18-85 years

Phase:

PHASE2

PHASE3

Brief Summary

Retrospective study on the efficacy of baricitinib in 12 COVID-19 patients with moderate pneumonia.

Detailed Description

Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2 that inhibits JAK1- and JAK2-mediated cytokine release, was recently described using BenevolentAI's proprietary arti...

Eligibility Criteria

Inclusion

  • SARS-Co-V2 positivitity to the nasal-swab by reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested by the local diagnostic laboratory
  • Age \>18 and \<85 years
  • Presence of at least 3 of the following symptoms as present fever, cough, myalgia, fatigue.
  • Presence of radiological findings of pneumonia assessed by chest radiograph, computed tomography, or pulmonary ultrasound.
  • Peripheral capillary oxygen saturation (SpO2) \> 92% on room air at screening
  • PaO2/FiO2 \>100-300 mmHg at arterial blood gas analysis.

Exclusion

  • Age \< 18 and \>85
  • History of thrombophlebitis
  • Latent tuberculosis infection (based on the positivity to QuantiFERON Plus positivity, Qiagen, Germany)
  • Pregnancy and lactation
  • History of malignancies over the previous 5 years, current diagnosis of malignancy
  • Inability or unwillingness to sign a written consent.
  • Transaminases values 4-fold higher than the upper normal limit.
  • HBV and HCV positivity.
  • Current Herpes zoster infection.
  • Evidence of concomitant bacterial infections.

Key Trial Info

Start Date :

March 16 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 7 2020

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT04358614

Start Date

March 16 2020

End Date

April 7 2020

Last Update

April 24 2020

Active Locations (1)

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1

Fabrizio Cantini

Prato, Tuscany, Italy, 59100