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

Sponsor
Università Politecnica delle Marche
Study ID
NCT04390061
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    Jak-1/3 inhibitor
  • Hydroxychloroquine — DRUG
    Standard Therapy

Study Details

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.

Key Dates

Start date
Jun 30, 2020
Status verified
May 2020
Primary completion
Sep 30, 2020
Completion
Oct 31, 2020

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tofacitinib+HYQ
    Tofacitinib 10mg cp twice a day + Hydroxychloroquine 200mg cp three times a day, both for 14 days
  • Active Comparator: Hydroxychloroquine
    Hydroxychloroquine 200mg cp three times a day for 14 days

Primary Outcome Measure

Prevention of severe Respiratory Failure requiring mechanical ventilation [ Time Frame: 14 days ]

Central Contacts

Related Studies