Pharmacological Action
Conditions
Keywords
COVID-19, Baricitinib, Moderate disease, Infection
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.
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).
Interventions
DRUGBaricitinib
Baricitinib 4 mg/day/orally combined to antiviral therapy ritonavir for 2 weeks. Baricitinib tablets 4 mg were administered in the morning.
Sponsors
Hospital of Prato
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Exclusion criteria
* Age less than 18 * History of thrombophlebitis. * Patient with latent tuberculosis infection (Quantiferon test). * Pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactFabrizio Cantini, MD
Backup ContactLaura Niccoli, MD
Outcome results
None listed