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Baricitinib Compared to Standard Therapy in Patients With COVID-19

NCT04393051 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2020-05-20

No results posted yet for this study

Summary

There is urgent need of an effective therapy for Covid-19. To date, the best treatment of SARS-CoV-2 infection is unknown. Baricitinib has been identified as potential treatment for 2019-nCoV acute respiratory disease, because of its immunomodulating and hypothesized antiviral activity.

This is a multicenter randomized clinical trial that aims to evaluate the efficacy and safety of baricitinib in patients with SARS-CoV2 pneumonia. Patients will be randomized to receive or not baricitinib as adjunctive therapy. All patients will continue to receive the ongoing standard therapy: chloroquine/idrossichloroquine and low-molecular weight heparin (LMWH) eventually associated with ritonavir/lopinavir or darunavir/ritonavir will be allowed for all included patients.

The primary endpoint measure is the efficacy of baricitinib in reducing the number of patients requiring invasive ventilation after 7 and 14 days of treatment.

Secondary endpoints will be mortality rates and toxicity of baricitinib.

Conditions

Interventions

DRUG

Baricitinib Oral Tablet

Baricitinib will be administered by oral route at different dosages according to age and kidney function. The drug will be administered for 14 days, unless occurrence of discontinuation criteria.

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

    lead OTHER

Principal Investigators

  • Francesco Menichetti, MD · Azienda Ospedaliero, Universitaria Pisana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-20
Primary Completion
2020-06-30
Completion
2020-07-30

Countries

  • Italy

Study Locations

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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 NCT04393051 on ClinicalTrials.gov