Baricitinib Therapy in COVID-19

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04358614

Enrollment

Registered

2020-04-24

Start date

2020-03-16

Completion date

2020-04-07

Last updated

2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID, Pneumonia

Keywords

COVID-19, BARICITINIB, MODERATE DISEASE

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.

Interventions

DRUGBaricitinib 4 MG Oral Tablet

Baricitinib+antiviral therapy administration for 2 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Baricitinib treated patients compared with controls (previously COVID-19 receving standard therapy)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026