BARI-COVID: Baricitinib in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study.

Sponsor

Hospital of Prato (Other)

Overall Status

Unknown status

CT.gov ID

NCT04320277

Collaborator

(none)

200

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

81.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is no specific antiviral treatment recommended for COVID-19, and no vaccine is currently available. Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2. The drug was found capable to reduce or interrupt the passage of the virus into target cells, and to inhibit the JAK1- and JAK2-mediated cytokine release. The drug was licensed for the treatment of rheumatoid arthritis at the daily dose of 4 mg/orally, with excellent results in terms of clinical response and a good safety profile. Since baricitinib does not interact with antivirals due to its prevalent renal elimination, it may be used in combination.The evidence on the advantageous action of baricitinib on viral entry and cytokine outbreak constituted the rationale to perform a trial on patients with mild to moderate COVID-19 infection receiving baricitinib combined with antiviral therapy.

Condition or Disease	Intervention/Treatment	Phase
Pharmacological Action	Drug: Baricitinib	Phase 2/Phase 3

Detailed Description

Study design. Interventional, open-label, 2-week, prospective trial of a cohort of patients with mild to moderate COVID-19 infection.

Objectives. Primary. To assess the efficacy of baricitinib combined with antiviral therapy in patients with COVID-19-related mild and moderate disease in terms of reduction of the percentage of subjects requiring ICU admission.

Secondary objectives. To describe the clinical findings in a cohort of symptomatic COVID-19-infected subjects; to investigate the role of CRP, IL-6, and TNFα levels as predictor of progression to ARDS; to assess the type and incidence of adverse events (AEs).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Patients. All consecutive patients with mild to moderate COVID-19 infection, older than 18, Patients should present fever, cough and myalgia and weakness and radiological findings of pneumonia. Controls. All consecutive patients with mild to moderate COVID-19 infection, older than 18, admitted during the previous 2 weeks, who were treated with antiviral and/or hydroxychloroquine.Patients. All consecutive patients with mild to moderate COVID-19 infection, older than 18, Patients should present fever, cough and myalgia and weakness and radiological findings of pneumonia. Controls. All consecutive patients with mild to moderate COVID-19 infection, older than 18, admitted during the previous 2 weeks, who were treated with antiviral and/or hydroxychloroquine.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Baricitinib Combined With Antiviral Therapy in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study

Anticipated Study Start Date :

May 16, 2020

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Jul 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients All patients received baricitinib combined to antiviral therapy lopinavir/ritonavir for 2 weeks.	Drug: Baricitinib Baricitinib 4 mg/day/orally combined to antiviral therapy ritonavir for 2 weeks. Baricitinib tablets 4 mg were administered in the morning. Other Names: Lopinavir/Ritonavir tablets 250 mg/bid
Active Comparator: Controls All consecutive patients with mild to moderate COVID-19 infection, older than 18, a during the previous 2 weeks, who were treated with antiviral and/or hydroxychloroquine.	Drug: Baricitinib Baricitinib 4 mg/day/orally combined to antiviral therapy ritonavir for 2 weeks. Baricitinib tablets 4 mg were administered in the morning. Other Names: Lopinavir/Ritonavir tablets 250 mg/bid

Arm

Intervention/Treatment

Experimental: Patients

All patients received baricitinib combined to antiviral therapy lopinavir/ritonavir for 2 weeks.

Drug: Baricitinib

Baricitinib 4 mg/day/orally combined to antiviral therapy ritonavir for 2 weeks. Baricitinib tablets 4 mg were administered in the morning.

Other Names:

Lopinavir/Ritonavir tablets 250 mg/bid

Active Comparator: Controls

All consecutive patients with mild to moderate COVID-19 infection, older than 18, a during the previous 2 weeks, who were treated with antiviral and/or hydroxychloroquine.

Drug: Baricitinib

Baricitinib 4 mg/day/orally combined to antiviral therapy ritonavir for 2 weeks. Baricitinib tablets 4 mg were administered in the morning.

Other Names:

Lopinavir/Ritonavir tablets 250 mg/bid

Outcome Measures

Primary Outcome Measures

The percentage of patients requiring transfer to ICU as compared with the rate of transfers observed in controls. [2 weeks]
The percentage of ICU admission in patients and controls will be compared for statistical difference

Secondary Outcome Measures

The percentage of patients achieving the remission; CRP, IL-6 and TNFα values at baseline and during the treatment course; the number of AEs. [2 weeks]
CRP values will be evaluated for prediction of disease worsening.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All consecutive patients with mild to moderate COVID-19 infection
Age >18 years,
Clinical diagnosis of COVID19 infection
Patients should present fever, cough and myalgia and weakness and radiological findings of pneumonia.
All patients should be willing and able to provide written informed consent prior to performing study procedures.