Baricitinib Therapy in COVID-19

Fabrizio Cantini12 enrolled

Overview

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

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 artificial intelligence-derived knowledge graph, as an agent that reduces the endocytosis into target cells, and to inhibit the entry. Based on its potential action on inhibition of SARS-CoV-2 entry, and on its known effects on reduction of cytokine release, baricitinib therapy was proposed in patients with moderate pneumonia to explore: the safety of this drug combined with antiviral (lopinavir-ritonavir) in COVID-19; as second outcome, to evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters, and reduction of ICU admission. Baricitinib was combined with antivirals because it does not interact with them due to its prevalent renal elimination.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID Pneumonia

Interventions

Baricitinib 4 MG Oral TabletDRUG

Baricitinib+antiviral therapy administration for 2 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fabrizio Cantini

Prato, Tuscany, Italy

Outcomes

Primary Outcomes

To assess the safety of baricitinib combined with antiviral (lopinavir-ritonavir) in terms of serious or non-serious adverse events incidence rate.

All adverse event recording

Time frame: 2 weeks

Secondary Outcomes

To evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters.

The percentage of patients improving the clinical and respiratory parameters compared with controls.

Time frame: 2 weeks

ICU admission rate

The percentage of ICU admission in baricitinib group as compared with controls.

Time frame: 2 weeks

Discharge rate.

The percentage of discharged in baricitinib group as compared with controls.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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