Baricitinib for coRona Virus pnEumonia (COVID-19): a THerapeutic Trial

NCT ID: NCT04399798

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2020-11-15

Brief Summary

The objective of the study is to assess the efficacy and safety of Baricitinib in the treatment of patients with COVID-19 pneumonia.

This will be a proof-of-concept trial with an exploratory single-arm proof of concept Phase IIa study to assess the efficacy and safety profile of Baricitinib in a limited number of patients with severe acute respiratory syndrome (SARS)-CoV-2 pneumonia. If the initial proof of concept phase will lead to favourable results, an open-label, Phase II, randomized controlled trial will be then designed and performed to confirm the results obtained in the proof of concept phase. The proof-of-concept phase guarantees that no safety issues arise on a limited number of patients in the use of a drug new to the current condition being treated.

Detailed Description

Baricitinib 4 mg/daily will be prescribed for 7 days to eligible patients showing signs of acute inflammatory response activation. The primary outcome of the study will be the response to treatment. A patient is considered responder in the absence of either moderate to severe oxygenation impairment or death, whichever occurs first, within 8 days from enrolment. The main secondary outcomes will include the responder rate and mortality at 15 days, the quantification of patients experiencing moderate to severe oxygenation impairment, rate of patients admitted to the intensive care unit, length of hospitalization, mortality at 28 days, rate of re-admission, and adverse events. The duration of the study will be 28 days. In the proof of concept phase, 13 patients will be enrolled; if the responders will be at least 4 patients without safety issues, Baricitinib will be considered for further studies.

Conditions

Corona Virus Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Baricitinib active treatment

Baricitinib 4 mg/day

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

4 mg/day for 7 days

Interventions

Baricitinib

4 mg/day for 7 days

Intervention Type: DRUG

Other Intervention Names

Olumiant

Eligibility Criteria

Inclusion Criteria

• Ability to obtain informed patient consent noting the limitations of existing knowledge regarding Baricitinib's efficacy and the labeled warning and precautions as the proposed use is outside the approved indication, as well as the presence of known risk of being treated with Baricitinib while the subject of an active infection
• informed Consent as documented by signature
• patients with a confirmed SARS-CoV-2 pneumonia
• adult patients aged 18-74 years old
• infiltrates at chest radiography
• c-reactive protein level greater than 10 mg/dl or ferritin level > 900 ug/L
• Lymphocyte count less than 1500/mmc
• > 200 PaO2/FiO2 ≤ 300

Exclusion Criteria

• patients aged < 18 years old and ≥ 75 years old
• concomitant bacterial infection
• lymphopenia less than 500/mmc
• hemoglobin < 8 g/dl
• absolute neutrophil count < 1 x 109 cells/L
• requiring continuous positive airway pressure (C-PAP) or mechanical ventilation
• sudden clinical deterioration requiring intensive care unit access
• known hypersensitivity or allergy to the study drug
• Creatinine clearance < 30 mL/min; if the creatinine clearance is between 30 and 60 mL/min the dose of Baricitinib should be reduced to 2 mg/daily
• Severe hepatic impairment (no dose adjustment of Baricitinib is required in mild or moderate hepatic impairment)
• Pregnant or breast-feeding
• Active tuberculosis
• Evidence of active hepatitis B (HBV) (HbsAg positive) or with detectable hepatitis C virus (HCV)-RNA, human immunodeficiency virus (HIV)
• Ongoing, acute diagnosis of deep venous thrombosis/pulmonary embolism (DVT/PE)
• Previous diagnosis of DVT/PE

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Carlomaurizio Montecucco

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlomaurizio Montecucco, Prof

Role: PRINCIPAL_INVESTIGATOR

Rheumatology, IRCCS Fondazione Policlinico S. Matteo, Pavia, Italy

Raffaele Bruno, Prof

Role: STUDY_CHAIR

Infectious Diseases; IRCCS Fondazione Policlinico S. Matteo, Pavia, Italy

Central Contacts

Sara Monti, MD

Role: CONTACT

sara.saramonti@gmail.com

0382501878

Valentina Zuccaro, MD

Role: CONTACT

V.Zuccaro@smatteo.pv.it

0382501080

References

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.

Reference Type: BACKGROUND

PMID: 32032529 (View on PubMed)

Stebbing J, Phelan A, Griffin I, Tucker C, Oechsle O, Smith D, Richardson P. COVID-19: combining antiviral and anti-inflammatory treatments. Lancet Infect Dis. 2020 Apr;20(4):400-402. doi: 10.1016/S1473-3099(20)30132-8. Epub 2020 Feb 27. No abstract available.

Reference Type: BACKGROUND

PMID: 32113509 (View on PubMed)

Other Identifiers

2020-001185-11

Identifier Type: -

Identifier Source: org_study_id