Baricitinib Therapy in COVID-19

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ClinicalTrials.gov Identifier: NCT04358614

Recruitment Status : Completed

First Posted : April 24, 2020

Last Update Posted : April 24, 2020

Sponsor:

Information provided by (Responsible Party):

Fabrizio Cantini, Hospital of Prato

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
COVID Pneumonia	Drug: Baricitinib 4 MG Oral Tablet	Phase 2 Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Allocation:	Non-Randomized
Intervention Model:	Crossover Assignment
Intervention Model Description:	Baricitinib treated patients compared with controls (previously COVID-19 receving standard therapy)
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Baricitinib Therapy in COVID-19: A Pilot Study on Safety and Clinical Impact
Actual Study Start Date :	March 16, 2020
Actual Primary Completion Date :	April 5, 2020
Actual Study Completion Date :	April 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Arms and Interventions

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 Name: Lopinavir/Ritonavir tablets 250 mg/bid
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 Name: Lopinavir/Ritonavir tablets 250 mg/bid

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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.
ICU admission rate [ Time Frame: 2 weeks ]
The percentage of ICU admission in baricitinib group as compared with controls.
Discharge rate. [ Time Frame: 2 weeks ]
The percentage of discharged in baricitinib group as compared with controls.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04358614

Locations

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Italy
Fabrizio Cantini
Prato, Tuscany, Italy, 59100

Sponsors and Collaborators

Fabrizio Cantini

More Information

Publications:

Conner SD, Schmid SL. Identification of an adaptor-associated kinase, AAK1, as a regulator of clathrin-mediated endocytosis. J Cell Biol. 2002 Mar 4;156(5):921-9. Epub 2002 Mar 4.

Ferner RE, Aronson JK. Chloroquine and hydroxychloroquine in covid-19. BMJ. 2020 Apr 8;369:m1432. doi: 10.1136/bmj.m1432.

Richardson P, Griffin I, Tucker C, Smith D, Oechsle O, Phelan A, Stebbing J. Baricitinib as potential treatment for 2019-nCoV acute respiratory disease. Lancet. 2020 Feb 15;395(10223):e30-e31. doi: 10.1016/S0140-6736(20)30304-4. Epub 2020 Feb 4.

Stebbing J, Phelan A, Griffin I, Tucker C, Oechsle O, Smith D, Richardson P. COVID-19: combining antiviral and anti-inflammatory treatments. Lancet Infect Dis. 2020 Apr;20(4):400-402. doi: 10.1016/S1473-3099(20)30132-8. Epub 2020 Feb 27.

Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6.

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Responsible Party:	Fabrizio Cantini, MD, Head of Rheumatology Department, Principal investigator, Hospital of Prato
ClinicalTrials.gov Identifier:	NCT04358614
Other Study ID Numbers:	HPrato-4
First Posted:	April 24, 2020 Key Record Dates
Last Update Posted:	April 24, 2020
Last Verified:	April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Fabrizio Cantini, Hospital of Prato:


COVID-19 BARICITINIB MODERATE DISEASE

Additional relevant MeSH terms:

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Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Ritonavir Lopinavir HIV Protease Inhibitors Protease Inhibitors	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

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