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Trial record 1 of 15 for:    tofacitinib | Italy
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TOFAcitinib in SARS-CoV2 Pneumonia

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332042
Recruitment Status : Not yet recruiting
First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Armando Gabrielli, Università Politecnica delle Marche

Brief Summary:
Immune-mediated lung injury plays a pivotal role in severe interstitial pnemumonia related to SARS-CoV2 infection. Tofacitinib, a JAK1/3-Inhibitor, could mitigate alveolar inflammation by blocking IL-6 signal. The aim of this prospective single cohort open study is to test the hypotesis that early administration of tofacitinib in patients with symptomatic pneumonia could reduce pulmonary flogosis, preventing function deterioration and the need of mechanical ventilation and/or admission in intensive care units.

Condition or disease Intervention/treatment Phase
SARS-COv2 Related Interstitial Pneumonia Drug: Tofacitinib Phase 2

Detailed Description:
Interstitial Pneumonia is the main complication of SARS-CoV2 infection. Immune system hyperactivation, leading to alveolar inflammation, is the main mechanism in determining lung damage. Evidence are accumulating about the pivotal role played by IL-6 in this disease. Preliminary evidence, indeed, point out the efficacy of an IL-6 receptor inhibitor in improving clinical conditions in a proportion of rapidly deteriorating patients. Our hypotesis is that a precocious inhibition of IL-6 signal, by the administration of tofacitinib (JAK 1/3 Inhibitor), could hinder the progression to more severe grades of lung inflammation leading to pulmonary function deterioration. In a prospective single cohort open study, 50 patients admitted in Hospital due to SARS-CoV 2 symptomatic interstitial pneumonia, but not requiring mechanical ventilation, will be enrolled. Tofacitinb will be administered every day for 14 days, starting within 24 h from the admission. The primary outcome is to evaluate the effect of this drug on the rate of patients who will need mechanical ventilation. Safety in this population will also be actively monitored.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TOFAcitinib in Patients With Early Onset SARS-CoV2 Interstitial Pneumonia
Estimated Study Start Date : April 10, 2020
Estimated Primary Completion Date : June 20, 2020
Estimated Study Completion Date : July 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: tofacitinib
Tofacitinib cp 5mg: 2pills twice a day for 14 days
Drug: Tofacitinib
Tofacitinib 10mg twice a day will be administered within 24h from hospital admission for 14 days




Primary Outcome Measures :
  1. need of mechanical ventilation [ Time Frame: day 14 ]
    Rate of patients needing mechanical ventilation to maintain PaO2/FIO2>150 or, if PaO2 data not available, to maintain SO2>94% with FiO2 0,5.


Secondary Outcome Measures :
  1. need of admission in intensive care unit [ Time Frame: day 14 ]
    Rate of patients needing admission to the intensive care unit for oro-tracheal intubation and/or evidence of Multiple Organ Disfunction

  2. death [ Time Frame: day 28 ]
    rate of patients dead

  3. rate of adverse events [ Time Frame: day 28 ]
    rate and type of adverse events



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SARS-CoV2 Infection diagnosed by rt-PCR
  • Rx or CT-scan confirmed interstitial pneumonia
  • Hospital admission from less than 24h
  • Written Informed Consent

Exclusion Criteria:

  • Age <18 ys or >65
  • Patients in mechanical ventilation at time of admission
  • Severe Hearth failure (NYHA 3 or 4)
  • Severe History of Chronic Ischemic Hearth Disease, defined as history of Major Adverse Cardiovascular Event and/or recent (one year) revascularization.
  • History of recurrent Deep Venous Thrombosis and Pulmonary Embolism
  • Active Bacterial or Fungal Infection
  • Hematological cancer
  • Metastatic or intractable cancer
  • Pre-existent neurodegenerative disease
  • Severe Hepatic Impairment
  • Severe Renal Failure (Creatinine Clearance <30ml/h)
  • Active Herpes zoster infection
  • Severe anemia (Hb<9g/dl)
  • Lymphocyte count below 750/mcl
  • Neutrophil count below 1000/mcl
  • Platelet count below 50000/mcl
  • Pregnancy or Lactation
  • Inability to give informed consent (severe transitory or permanent mental impairment, incapacitation)

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): NCT04332042


Locations
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Italy
Ospedali Riuniti di Ancona
Ancona, Marche, Italy, 60126
Contact: Armando Gabrielli, Prof    +390712206104    a.gabrielli@staff.univpm.it   
Principal Investigator: Armando Gabrielli, Prof         
Sub-Investigator: Giovanni Pomponio, Dr         
Sponsors and Collaborators
Università Politecnica delle Marche
Publications:
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Responsible Party: Armando Gabrielli, Full Professor Internal Medicine, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT04332042    
Other Study ID Numbers: TOFACoV
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 2, 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
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action