Baricitinib Compared to Standard Therapy in Patients With COVID-19

NCT04393051 | Unknown Phase 2 DMC

• 1 other identifier: BARICIVID-19
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Covid-19; SARS-CoV 2; SARS Pneumonia

Keywords

baricitinib; invasive ventilation; safety; pneumonia; SARS-CoV2; Covid-19

Outcome Measures

Primary Outcomes (1)

• Need of invasive mechanical ventilation

  Reduction of the number of patients requiring invasive ventilation

  after 7 and 14 days of treatment

Secondary Outcomes (9)

• Mortality

  14- and 28-days from randomization

• Time to invasive mechanical ventilation

  30 days

• Time to independence from non-invasive mechanical ventilation

  30 days

• Time to independence from oxygen therapy

  30 days

• Time to improvement in oxygenation for at least 48 hours

  30 days

Study Arms (2)

BAR group

EXPERIMENTAL

Patients who will be assigned (after a computerized randomization) to the BAR group will. receive baricitinib as adjunctive therapy. Baricitinib will be administered at 4 mg daily via oral route for 14 days as add-on therapy or 2 mg daily via oral route (eGFR between 30 and 60 ml/min and for patients with age \>75 years old) for 14 days as add-on therapy

Drug: Baricitinib Oral Tablet

Control group

NO INTERVENTION

Patients in the control group will continue to receive standard therapy.

Interventions

Baricitinib Oral Tablet DRUG

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.

BAR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender
• Age \> 18 years on day of signing informed consent
• Informed written consent for participation in the study
• Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
• Hospitalized due to clinical instrumental diagnosis of pneumonia.
• Oxygen saturation at rest in ambient air ≤93% or P/F ratio \<250
• Able to be administered by oral route drugs
• Patients who receive O2 therapy or who need non-invasive mechanical ventilation
• In case of female patients at childbearing potential, they should agree to use highly effective methods of birth control at least till 7 days after the termination of the treatments

You may not qualify if:

• Known hypersensitivity to Baricitinib or its excipients
• Patients with Creatinine Clearance \< 30 ml/min
• Patients with active Tuberculosis (TBC)
• Patients with known HBV or HCV infection
• Patients with deep vein thrombosis (DVP) or Pulmonary Embolism (PE)
• Patients with ALT or AST\> 5 times the upper limit of the normality
• Neutrophils \<1000/mmc
• Platelets \<50.000/mmc
• Hb\< 8g/dl
• Bowel diverticulitis or perforation
• Patients who receive invasive mechanical ventilation
• Documented bacterial infection at time of randomization
• Patients with "do not resuscitate order"
• Patients receiving immunosuppressants or anti-rejection drugs
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Related Publications (2)

• Richardson P, Griffin I, Tucker C, Smith D, Oechsle O, Phelan A, Rawling M, Savory E, Stebbing J. Baricitinib as potential treatment for 2019-nCoV acute respiratory disease. Lancet. 2020 Feb 15;395(10223):e30-e31. doi: 10.1016/S0140-6736(20)30304-4. Epub 2020 Feb 4. No abstract available.

  PMID: 32032529 RESULT

• Favalli EG, Biggioggero M, Maioli G, Caporali R. Baricitinib for COVID-19: a suitable treatment? Lancet Infect Dis. 2020 Sep;20(9):1012-1013. doi: 10.1016/S1473-3099(20)30262-0. Epub 2020 Apr 3. No abstract available.

  PMID: 32251638 RESULT

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Francesco Menichetti, MD

  Azienda Ospedaliero, Universitaria Pisana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Falcone, MD

CONTACT

050996735; marco.falcone@unipi.it

Giusy Tiseo, MD

CONTACT

050996343; tiseogiusy@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Phase II randomized clinical trial to evaluate the efficacy and safety of baricitinib in patients with SARS-CoV2 pneumonia

Study Record Dates

• First Submitted: May 16, 2020
• First Posted: May 19, 2020
• Study Start: May 20, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)