Baricitinib for coRona Virus pnEumonia (COVID-19): a THerapeutic Trial

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Study ID
NCT04399798
Phase
PHASE2
Status
Unknown

Conditions

  • Corona Virus Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The objective of the study is to assess the efficacy and safety of Baricitinib in the treatment of patients with COVID-19 pneumonia. This will be a proof-of-concept trial with an exploratory single-arm proof of concept Phase IIa study to assess the efficacy and safety profile of Baricitinib in a limited number of patients with severe acute respiratory syndrome (SARS)-CoV-2 pneumonia. If the initial proof of concept phase will lead to favourable results, an open-label, Phase II, randomized controlled trial will be then designed and performed to confirm the results obtained in the proof of concept phase. The proof-of-concept phase guarantees that no safety issues arise on a limited number of patients in the use of a drug new to the current condition being treated.

Key Dates

Start date
May 15, 2020
Status verified
May 2020
Primary completion
Sep 15, 2020
Completion
Nov 15, 2020

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib active treatment
    Baricitinib 4 mg/day

Primary Outcome Measure

Response to treatment: absence of moderate to severe oxygenation impairment (Berlin criteria) [ Time Frame: 8 days ]

Central Contacts

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