Baricitinib Therapy in COVID-19

• Status: Completed
• Trial end date: 2020-04-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fabrizio Cantini
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.