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TOFAcitinib in Patients With Early Onset SARS-CoV2 Interstitial Pneumonia

Trial Profile

TOFAcitinib in Patients With Early Onset SARS-CoV2 Interstitial Pneumonia

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 09 Apr 2020

At a glance

  • Drugs Tofacitinib (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Most Recent Events

    • 09 Apr 2020 According to a Pfizer media release, this study is planned to be initiated later this week and is supported by a Pfizer grant.
    • 06 Apr 2020 New trial record

Trial Overview

Purpose

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.

Primary Endpoints

need of mechanical ventilation

description: 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.
time_frame: day 14

Other Endpoints

need of admission in intensive care unit

description: Rate of patients needing admission to the intensive care unit for oro-tracheal intubation and/or evidence of Multiple Organ Disfunction
time_frame: day 14

death

description: rate of patients dead
time_frame: day 28

rate of adverse events

description: rate and type of adverse events
time_frame: day 28 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 50

  • Sex male & female
  • Age Group 18-65 years; adult

Patient 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

Patient 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)

Trial Details

Identifiers

Identifier Owner
NCT04332042 ClinicalTrials.gov: US National Institutes of Health
TOFACoV -

Organisations

  • Affiliations Pfizer

Trial Dates

  • Initiation Dates

    Planned : 10 Apr 2020

  • Primary Completion Dates

    Planned : 20 Jun 2020

  • End Dates

    Planned : 10 Jul 2020

Other Details

  • Design open; prospective
  • Phase of Trial Phase II
  • Location Italy
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
TofacitinibPrimary Drug Oral Pill

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)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Armando Gabrielli, Prof
+390712206104
a.gabrielli@staff.univpm.it
show details
Ospedali Riuniti di Ancona Italy
Giovanni Pomponio, Dr Ospedali Riuniti di Ancona Italy

Centres

Centre Name Location Trial Centre Country
Ospedali Riuniti di Ancona Ancona, Marche Italy
Università Politecnica delle Marche
-
-

Trial History

Event Date Event Type Comment
09 Apr 2020 Other trial event According to a Pfizer media release, this study is planned to be initiated later this week and is supported by a Pfizer grant. Updated 13 Apr 2020
06 Apr 2020 New trial record New trial record Updated 06 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Pfizer. Pfizer Advances Battle Against COVID-19 on Multiple Fronts. Media-Rel 2020;.

    Media Release
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