Covid-19 Clinical Trial
— BARICIVID-19Official title:
BARICIVID-19 STUDY: MultiCentre, Randomised, Phase IIa Clinical Trial Evaluating Efficacy and Tolerability of Baricitinib as add-on Treatment of In-patients With COVID-19 Compared to Standard Therapy
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.
Status | Not yet recruiting |
Enrollment | 126 |
Est. completion date | July 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero Universitaria Pisana | Pisa |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero, Universitaria Pisana |
Italy,
Favalli EG, Biggioggero M, Maioli G, Caporali R. Baricitinib for COVID-19: a suitable treatment? Lancet Infect Dis. 2020 Apr 3. pii: S1473-3099(20)30262-0. doi: 10.1016/S1473-3099(20)30262-0. [Epub ahead of print] — View Citation
Richardson P, Griffin I, Tucker C, Smith D, Oechsle O, Phelan A, 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Need of invasive mechanical ventilation | Reduction of the number of patients requiring invasive ventilation | after 7 and 14 days of treatment | |
Secondary | Mortality | Proportion of any cause deaths | 14- and 28-days from randomization | |
Secondary | Time to invasive mechanical ventilation | Days from randomization to invasive mechanical ventilation | 30 days | |
Secondary | Time to independence from non-invasive mechanical ventilation | Days from randomization to independence from non-invasive mechanical ventilation | 30 days | |
Secondary | Time to independence from oxygen therapy | Days from randomization to independence from oxygen therapy | 30 days | |
Secondary | Time to improvement in oxygenation for at least 48 hours | Days from randomization to improvement in oxygenation for at least 48 hours | 30 days | |
Secondary | Length of hospital stay | Days of hospital stay | 30 days | |
Secondary | Length of ICU stay | Days of ICU stay | 30 days | |
Secondary | Instrumental response | Changes in pulmonary echography | 30 days | |
Secondary | Proportion of adverse events | Rate of adverse events codified by Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0 | 30 days |
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