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

NCT04399798 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Corona Virus Infection

Interventions

DRUG

Baricitinib

4 mg/day for 7 days

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Carlomaurizio Montecucco, Prof · Rheumatology, IRCCS Fondazione Policlinico S. Matteo, Pavia, Italy

  • Raffaele Bruno, Prof · Infectious Diseases; IRCCS Fondazione Policlinico S. Matteo, Pavia, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2020-09-15
Completion
2020-11-15

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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 NCT04399798 on ClinicalTrials.gov