Baricitinib Compared to Standard Therapy in Patients With COVID-19 (BARICIVID-19)
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|ClinicalTrials.gov Identifier: NCT04393051|
Recruitment Status : Not yet recruiting
First Posted : May 19, 2020
Last Update Posted : May 20, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Covid-19 SARS-CoV 2 SARS Pneumonia||Drug: Baricitinib Oral Tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase II randomized clinical trial to evaluate the efficacy and safety of baricitinib in patients with SARS-CoV2 pneumonia|
|Masking:||None (Open Label)|
|Official 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|
|Estimated Study Start Date :||May 20, 2020|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||July 30, 2020|
Experimental: BAR group
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
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.
No Intervention: Control group
Patients in the control group will continue to receive standard therapy.
- Need of invasive mechanical ventilation [ Time Frame: after 7 and 14 days of treatment ]Reduction of the number of patients requiring invasive ventilation
- Mortality [ Time Frame: 14- and 28-days from randomization ]Proportion of any cause deaths
- Time to invasive mechanical ventilation [ Time Frame: 30 days ]Days from randomization to invasive mechanical ventilation
- Time to independence from non-invasive mechanical ventilation [ Time Frame: 30 days ]Days from randomization to independence from non-invasive mechanical ventilation
- Time to independence from oxygen therapy [ Time Frame: 30 days ]Days from randomization to independence from oxygen therapy
- Time to improvement in oxygenation for at least 48 hours [ Time Frame: 30 days ]Days from randomization to improvement in oxygenation for at least 48 hours
- Length of hospital stay [ Time Frame: 30 days ]Days of hospital stay
- Length of ICU stay [ Time Frame: 30 days ]Days of ICU stay
- Instrumental response [ Time Frame: 30 days ]Changes in pulmonary echography
- Proportion of adverse events [ Time Frame: 30 days ]Rate of adverse events codified by Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393051
|Contact: Marco Falcone, MDfirstname.lastname@example.org|
|Contact: Giusy Tiseo, MDemail@example.com|
|Azienda Ospedaliero Universitaria Pisana|
|Pisa, Italy, 56126|
|Contact: Marco Falcone firstname.lastname@example.org|
|Principal Investigator: Francesco Menichetti|
|Sub-Investigator: Marco Falcone|
|Principal Investigator:||Francesco Menichetti, MD||Azienda Ospedaliero, Universitaria Pisana|