Baricitinib Therapy in COVID-19

Phase 2

Completed

• Conditions: COVID; Pneumonia
• Interventions: Drug: Baricitinib 4 MG Oral Tablet

• Registration Number: NCT04358614
• Lead Sponsor: Fabrizio Cantini

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 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 Timeline

• Study Start: 2020-03-16
• Status Verified: 2020-04
• Primary Completion: 2020-04-05
• Study Completion: 2020-04-07
• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Case patients	Baricitinib 4 MG Oral Tablet	Consecutive patients with COVID moderate pneumonia treated with baricitinib tablets 4 mg/day
Controls	Baricitinib 4 MG Oral Tablet	Consecutive patients with COVID moderate pneumonia treated with standard therapy before the date of the first baricitinib-treated patient.

Primary Outcome Measures

Name	Time	Method
To assess the safety of baricitinib combined with antiviral (lopinavir-ritonavir) in terms of serious or non-serious adverse events incidence rate.	2 weeks	All adverse event recording

Secondary Outcome Measures

Name	Time	Method
To evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters.	2 weeks	The percentage of patients improving the clinical and respiratory parameters compared with controls.
ICU admission rate	2 weeks	The percentage of ICU admission in baricitinib group as compared with controls.
Discharge rate.	2 weeks	The percentage of discharged in baricitinib group as compared with controls.

Trial Locations

Locations (1)

Fabrizio Cantini; 🇮🇹 Prato, Tuscany, Italy