Baricitinib Therapy in COVID-19

Fabrizio Cantini

Status and phase: Completed; Phase 3; Phase 2

Conditions: COVID; Pneumonia

Treatments: Drug: Baricitinib 4 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04358614

HPrato-4

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

Case patients

Active Comparator group

Description:

Consecutive patients with COVID moderate pneumonia treated with baricitinib tablets 4 mg/day

Treatment:

Drug: Baricitinib 4 MG Oral Tablet

Controls

Other group

Description:

Consecutive patients with COVID moderate pneumonia treated with standard therapy before the date of the first baricitinib-treated patient.

Treatment:

Drug: Baricitinib 4 MG Oral Tablet