NCT04332042

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

April 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

April 2, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

March 28, 2020

Last Update Submit

April 1, 2020

Conditions

SARS-COv2 Related Interstitial Pneumonia

Outcome Measures

Primary Outcomes (1)

  • need of mechanical ventilation

    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.

    day 14

Secondary Outcomes (3)

  • need of admission in intensive care unit

    day 14

  • death

    day 28

  • rate of adverse events

    day 28

Study Arms (1)

tofacitinib

EXPERIMENTAL

Tofacitinib cp 5mg: 2pills twice a day for 14 days

Drug: Tofacitinib

Interventions

TofacitinibDRUG

Tofacitinib 10mg twice a day will be administered within 24h from hospital admission for 14 days

tofacitinib

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedali Riuniti di Ancona

Ancona, The Marches, 60126, Italy

Location

Related Publications (5)

  • Tian S, Hu W, Niu L, Liu H, Xu H, Xiao SY. Pulmonary Pathology of Early-Phase 2019 Novel Coronavirus (COVID-19) Pneumonia in Two Patients With Lung Cancer. J Thorac Oncol. 2020 May;15(5):700-704. doi: 10.1016/j.jtho.2020.02.010. Epub 2020 Feb 28.

    PMID: 32114094BACKGROUND

  • Ashour HM, Elkhatib WF, Rahman MM, Elshabrawy HA. Insights into the Recent 2019 Novel Coronavirus (SARS-CoV-2) in Light of Past Human Coronavirus Outbreaks. Pathogens. 2020 Mar 4;9(3):186. doi: 10.3390/pathogens9030186.

    PMID: 32143502BACKGROUND

  • Zumla A, Hui DS, Azhar EI, Memish ZA, Maeurer M. Reducing mortality from 2019-nCoV: host-directed therapies should be an option. Lancet. 2020 Feb 22;395(10224):e35-e36. doi: 10.1016/S0140-6736(20)30305-6. Epub 2020 Feb 5. No abstract available.

    PMID: 32035018BACKGROUND

  • Rose-John S, Scheller J, Schaper F. "Family reunion"--A structured view on the composition of the receptor complexes of interleukin-6-type and interleukin-12-type cytokines. Cytokine Growth Factor Rev. 2015 Oct;26(5):471-4. doi: 10.1016/j.cytogfr.2015.07.011. Epub 2015 Jul 6. No abstract available.

    PMID: 26235233BACKGROUND

  • McInnes IB, Byers NL, Higgs RE, Lee J, Macias WL, Na S, Ortmann RA, Rocha G, Rooney TP, Wehrman T, Zhang X, Zuckerman SH, Taylor PC. Comparison of baricitinib, upadacitinib, and tofacitinib mediated regulation of cytokine signaling in human leukocyte subpopulations. Arthritis Res Ther. 2019 Aug 2;21(1):183. doi: 10.1186/s13075-019-1964-1.

    PMID: 31375130BACKGROUND

MeSH Terms

Interventions

tofacitinib

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor Internal Medicine

Study Record Dates

First Submitted

March 28, 2020

First Posted

April 2, 2020

Study Start

April 10, 2020

Primary Completion

June 20, 2020

Study Completion

July 10, 2020

Last Updated

April 2, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)