Baricitinib Therapy in COVID-19

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

Detailed Description
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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.

Official Title
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Baricitinib Therapy in COVID-19: A Pilot Study on Safety and Clinical Impact

Conditions
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COVID, Pneumonia

Intervention / Treatment
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* Drug: Baricitinib 4 MG Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Baricitinib treated patients compared with controls (previously COVID-19 receving standard therapy)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Case patients<br>Consecutive patients with COVID moderate pneumonia treated with baricitinib tablets 4 mg/day | Drug: Baricitinib 4 MG Oral Tablet<br>* Baricitinib+antiviral therapy administration for 2 weeks<br>* Other names: Lopinavir/Ritonavir tablets 250 mg/bid;|
| Other: Controls<br>Consecutive patients with COVID moderate pneumonia treated with standard therapy before the date of the first baricitinib-treated patient. | Drug: Baricitinib 4 MG Oral Tablet<br>* Baricitinib+antiviral therapy administration for 2 weeks<br>* Other names: Lopinavir/Ritonavir tablets 250 mg/bid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks | 
| ICU admission rate | The percentage of ICU admission in baricitinib group as compared with controls. | 2 weeks | 
| Discharge rate. | The percentage of discharged in baricitinib group as compared with controls. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, BARICITINIB, MODERATE DISEASE