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Baricitinib Therapy in COVID-19

Primary Purpose

COVID, Pneumonia

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Baricitinib 4 MG Oral Tablet
Sponsored by
Fabrizio Cantini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID focused on measuring COVID-19, BARICITINIB, MODERATE DISEASE

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fabrizio Cantini

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Case patients

Controls

Arm Description

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

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

Outcomes

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.
All adverse event recording

Secondary Outcome Measures

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.
ICU admission rate
The percentage of ICU admission in baricitinib group as compared with controls.
Discharge rate.
The percentage of discharged in baricitinib group as compared with controls.

Full Information

First Posted
April 19, 2020
Last Updated
April 21, 2020
Sponsor
Fabrizio Cantini
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1. Study Identification

Unique Protocol Identification Number
NCT04358614
Brief Title
Baricitinib Therapy in COVID-19
Official Title
Baricitinib Therapy in COVID-19: A Pilot Study on Safety and Clinical Impact
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
April 5, 2020 (Actual)
Study Completion Date
April 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fabrizio Cantini

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Pneumonia
Keywords
COVID-19, BARICITINIB, MODERATE DISEASE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Baricitinib treated patients compared with controls (previously COVID-19 receving standard therapy)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case patients
Arm Type
Active Comparator
Arm Description
Consecutive patients with COVID moderate pneumonia treated with baricitinib tablets 4 mg/day
Arm Title
Controls
Arm Type
Other
Arm Description
Consecutive patients with COVID moderate pneumonia treated with standard therapy before the date of the first baricitinib-treated patient.
Intervention Type
Drug
Intervention Name(s)
Baricitinib 4 MG Oral Tablet
Other Intervention Name(s)
Lopinavir/Ritonavir tablets 250 mg/bid
Intervention Description
Baricitinib+antiviral therapy administration for 2 weeks
Primary Outcome Measure Information:
Title
To assess the safety of baricitinib combined with antiviral (lopinavir-ritonavir) in terms of serious or non-serious adverse events incidence rate.
Description
All adverse event recording
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
To evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters.
Description
The percentage of patients improving the clinical and respiratory parameters compared with controls.
Time Frame
2 weeks
Title
ICU admission rate
Description
The percentage of ICU admission in baricitinib group as compared with controls.
Time Frame
2 weeks
Title
Discharge rate.
Description
The percentage of discharged in baricitinib group as compared with controls.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Fabrizio Cantini
City
Prato
State/Province
Tuscany
ZIP/Postal Code
59100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11877461
Citation
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. doi: 10.1083/jcb.200108123. Epub 2002 Mar 4.
Results Reference
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PubMed Identifier
32269046
Citation
Ferner RE, Aronson JK. Chloroquine and hydroxychloroquine in covid-19. BMJ. 2020 Apr 8;369:m1432. doi: 10.1136/bmj.m1432. No abstract available.
Results Reference
background
PubMed Identifier
32032529
Citation
Richardson P, Griffin I, Tucker C, Smith D, Oechsle O, Phelan A, Rawling M, Savory E, 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. No abstract available. Erratum In: Lancet. 2020 Jun 20;395(10241):1906.
Results Reference
background
PubMed Identifier
32113509
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
11588210
Citation
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. doi: 10.1093/qjmed/94.10.521.
Results Reference
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Baricitinib Therapy in COVID-19

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