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TOFAcitinib Plus Hydroxycloroquine vs Hydroxycloroquine in Patients With COVID-19 Interstitial Pneumonia

NCT04390061 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2020-05-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tofacitinib

Jak-1/3 inhibitor

DRUG

Hydroxychloroquine

Standard Therapy

Sponsors & Collaborators

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    collaborator UNKNOWN

  • Ospedale Civile Santo Spirito, Pescara

    collaborator UNKNOWN

  • Università Magna Grecia, Catanzaro

    collaborator UNKNOWN

  • ASST Papa Giovanni XXIII, Bergamo

    collaborator UNKNOWN

  • Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma

    collaborator UNKNOWN

  • ASST Cremona, Cremona

    collaborator UNKNOWN

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    collaborator OTHER

  • Ospedale di Circolo e Fondazione Macchi, Varese

    collaborator UNKNOWN

  • Università Politecnica delle Marche

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2020-09-30
Completion
2020-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390061 on ClinicalTrials.gov