Baricitinib Therapy in COVID-19

April 21, 2020 updated by: Fabrizio Cantini

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Tuscany
      • Prato, Tuscany, Italy, 59100
        • Fabrizio Cantini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Case patients
Consecutive patients with COVID moderate pneumonia treated with baricitinib tablets 4 mg/day
Drug: Baricitinib 4 MG Oral Tablet
Baricitinib+antiviral therapy administration for 2 weeks
Other Names:
  • Lopinavir/Ritonavir tablets 250 mg/bid
Other: Controls
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
Baricitinib+antiviral therapy administration for 2 weeks
Other Names:
  • Lopinavir/Ritonavir tablets 250 mg/bid

What is the study measuring?

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.
Time Frame: 2 weeks
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.
Time Frame: 2 weeks
The percentage of patients improving the clinical and respiratory parameters compared with controls.
2 weeks
ICU admission rate
Time Frame: 2 weeks
The percentage of ICU admission in baricitinib group as compared with controls.
2 weeks
Discharge rate.
Time Frame: 2 weeks
The percentage of discharged in baricitinib group as compared with controls.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fabrizio Cantini

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2020

Primary Completion (Actual)

April 5, 2020

Study Completion (Actual)

April 7, 2020

Study Registration Dates

First Submitted

April 19, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 21, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPrato-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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