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Trial record 1 of 17 for:    tofacitinib | Italy
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TOFAcitinib in SARS-CoV2 Pneumonia

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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

Tracking Information
First Submitted Date  ICMJE March 28, 2020
First Posted Date  ICMJE April 2, 2020
Last Update Posted Date April 2, 2020
Estimated Study Start Date  ICMJE April 10, 2020
Estimated Primary Completion Date June 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • 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
  • death [ Time Frame: day 28 ]
    rate of patients dead
  • rate of adverse events [ Time Frame: day 28 ]
    rate and type of adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TOFAcitinib in SARS-CoV2 Pneumonia
Official Title  ICMJE TOFAcitinib in Patients With Early Onset SARS-CoV2 Interstitial Pneumonia
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
prospective cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE SARS-COv2 Related Interstitial Pneumonia
Intervention  ICMJE Drug: Tofacitinib
Tofacitinib 10mg twice a day will be administered within 24h from hospital admission for 14 days
Study Arms  ICMJE Experimental: tofacitinib
Tofacitinib cp 5mg: 2pills twice a day for 14 days
Intervention: Drug: Tofacitinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 10, 2020
Estimated Primary Completion Date June 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04332042
Other Study ID Numbers  ICMJE TOFACoV
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Armando Gabrielli, Università Politecnica delle Marche
Study Sponsor  ICMJE Università Politecnica delle Marche
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Università Politecnica delle Marche
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP