Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Baricitinib Therapy in COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Drug Information available for: Baricitinib

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. 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. ICU admission rate [ Time Frame: 2 weeks ]
    The percentage of ICU admission in baricitinib group as compared with controls.

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Italy
Fabrizio Cantini
Prato, Tuscany, Italy, 59100
Sponsors and Collaborators
Fabrizio Cantini
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
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

Layout table for additional information
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:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ritonavir
 Lopinavir
HIV Protease Inhibitors
Viral 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