TOFAcitinib Plus Hydroxycloroquine vs Hydroxycloroquine in Patients With COVID-19 Interstitial Pneumonia
Status:
Not yet recruiting
Trial end date:
2020-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Università Politecnica delle Marche
Collaborators:
ASST Cremona, Cremona ASST Papa Giovanni XXIII, Bergamo Azienda Ospedaliera Ospedali Riuniti Marche Nord Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milano Ospedale Civile Santo Spirito, Pescara Ospedale di Circolo e Fondazione Macchi, Varese Università Magna Grecia, Catanzaro