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

NCT04399798 | Unknown Phase 2 DMC

• 1 other identifier: 2020-001185-11
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Corona Virus Infection

Outcome Measures

Primary Outcomes (2)

• Response to treatment: absence of moderate to severe oxygenation impairment (Berlin criteria)

  A patient is consider responder in the absence of either moderate to severe oxygenation impairment according to Berlin criteria - measured as Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2)

  8 days

• Response to treatment: survival

  Absence of death within 8 days from enrollment

  8 days

Secondary Outcomes (13)

• To quantify the rate of each of: moderate or severe oxygenation impairment within 8 days

  8 days

• To quantify the rate of each of: moderate or severe oxygenation impairment within 15 days

  15 days

• Mortality

  8 days and 15 days

• Peripheral capillary oxygen saturation (SpO2)

  8 days; 15 days

• Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2)

  8 days; 15 days

Study Arms (1)

Baricitinib active treatment

EXPERIMENTAL

Baricitinib 4 mg/day

Drug: Baricitinib

Interventions

Baricitinib DRUG

4 mg/day for 7 days

Also known as: Olumiant

Baricitinib active treatment

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

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 BACKGROUND

• 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.

  PMID: 32113509 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Carlomaurizio Montecucco, Prof

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

  PRINCIPAL INVESTIGATOR

• Raffaele Bruno, Prof

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

  STUDY CHAIR

Central Study Contacts

Sara Monti, MD

CONTACT

0382501878; sara.saramonti@gmail.com

Valentina Zuccaro, MD

CONTACT

0382501080; V.Zuccaro@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Proof-of-concept trial with an exploratory single-arm proof of concept Phase IIa study

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 22, 2020
• Study Start: May 15, 2020
• Primary Completion: September 15, 2020
• Study Completion: November 15, 2020
• Last Updated: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share