NCT04390061

Brief Summary

Multifocal interstitial pneumonia represents the most common cause of admission in intensive care units and death in SARS-CoV2 infections. In our Hospital, similarly to what reported in literature, up to 25% of admitted patients with pneumonitis requires mechanical ventilation or oro-tracheal intubation within 5-10 days. No established treatment is available for this condition. Preliminary evidence is accumulating about the efficacy of an aggressive treatment of the corona virus-induced inflammation and, in particular, investigators believe that blocking JAK1 is clinically rewarding in down-regulating IL-6 driven inflammation in patients with corona-virus infection. Thus, investigators designed a randomized controlled trial to test the hypothesis that adding Tofacitinib to the standard treatment in the early phase of COVID related pneumonitis could prevent the development of severe respiratory failure needing mechanical ventilation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_2

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

May 13, 2020

Last Update Submit

May 14, 2020

Conditions

Pneumonitis, InterstitialCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Prevention of severe Respiratory Failure requiring mechanical ventilation

    Rate of patients needing mechanical ventilation to maintain PaO2/FIO2\>150

    14 days

Secondary Outcomes (4)

  • Prevention of need of ICU admission

    28 days

  • Prevention of COVID-19 related Deaths

    28 days

  • Identification of predictors of outcome

    14 days

  • Incidence of Treatment-Emergent Adverse Events

    28 days

Study Arms (2)

tofacitinib+HYQ

EXPERIMENTAL

Tofacitinib 10mg cp twice a day + Hydroxychloroquine 200mg cp three times a day, both for 14 days

Drug: TofacitinibDrug: Hydroxychloroquine

Hydroxychloroquine

ACTIVE COMPARATOR

Hydroxychloroquine 200mg cp three times a day for 14 days

Drug: Hydroxychloroquine

Interventions

TofacitinibDRUG

Jak-1/3 inhibitor

Also known as: Xeljanz
tofacitinib+HYQ
HydroxychloroquineDRUG

Standard Therapy

Hydroxychloroquinetofacitinib+HYQ

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
  • CT-scan confirmed interstitial pneumonia
  • Hospital admission from less than 24h
  • P/F ratio \>150 mmHg
  • 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)
  • QTc \> 470 ms or \>500 ms in wide QRS patients
  • Severe History of Chronic Ischemic Heart Disease, defined as history of Major Adverse Cardiovascular Event and/or recent (one year) revascularization.
  • History of recurrent Deep Venous Thrombosis and Pulmonary Embolism or established thrombophilic conditions (e.g. history of anti-phospholipid antibodies, …)
  • Active Bacterial or Fungal Infection
  • Hematological cancer
  • Metastatic or intractable cancer
  • Pre-existent neurodegenerative disease
  • Severe Hepatic Impairment,
  • History of acute diverticular disease or intestinal perforation
  • HBsAg positive and/or HBV-DNA positive patients
  • Severe Renal Failure (Creatinine Clearance \<30ml/h)
  • Active Herpes zoster infection
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases, InterstitialCOVID-19

Interventions

tofacitinibHydroxychloroquine

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Armando Gabrielli, MD

CONTACT

0712206104a.gabrielli@staff.univpm.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter open label randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor Internal Medicine

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 15, 2020

Study Start

June 1, 2020

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share