Corona Virus InfectionPhase 2BREATHNCT04399798
Baricitinib for coRona Virus pnEumonia (COVID-19): a THerapeutic Trial
A Phase 2 study testing Baricitinib in people with Corona Virus Infection, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- Baricitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2020to 15 Nov 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A proof-of Concept Study of the Use of Janus Kinase 1 and 2 Inhibitor, Baricitinib, in the Treatment of COVID-19-related Pneumonia
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.
Read the 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
- Being tested
- Baricitinib
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called Olumiant
4 mg/day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib active treatment | Experimental | Baricitinib 4 mg/day Receives: Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 days
Response to treatment: survival
Absence of death within 8 days from enrollment
Measured: 8 days
Secondary outcomes (13)
To quantify the rate of each of: moderate or severe oxygenation impairment within 8 days
Moderate to severe oxygenation impairment according to Berlin criteria (measured as PaO2/FiO2)
Measured: 8 days
To quantify the rate of each of: moderate or severe oxygenation impairment within 15 days
Moderate to severe oxygenation impairment according to Berlin criteria (measured as PaO2/FiO2)
Measured: 15 days
Mortality
To quantify mortality within 8 and 15 days
Measured: 8 days and 15 days
Peripheral capillary oxygen saturation (SpO2)
SpO2 will be assessed with the median and 25th-75th percentiles
Measured: 8 days; 15 days
Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2)
PaO2/FiO2 will be assessed with the median and 25th-75th percentiles
Measured: 8 days; 15 days
To assess the rate of patients admitted to the intensive care unit
Number of patients over the number of patients enrolled
Measured: 8 days; 15 days
To measure the length of hospital stay
Median number of days and 25th-75th percentiles
Measured: 8 days; 15 days
28-day mortality
To quantify 28-day mortality
Measured: 28 days
To quantify the rate of re-admission within 28 days
Number of patients readmitted over the number patients enrolled
Measured: 28 days
To quantify the cumulative incidence and severity of adverse events
Number, type, and severity of adverse events
Measured: 28 days
Interleukin (IL)-1; IL-2; IL-10; IL-6; IL-8; IL-17; IL-2 receptor levels;
Serial serum assessments from baseline up to 15 days
Measured: 15 days
TNFalpha; vascular endothelial growth factor (VEGF); interferon gamma (IFNgamma) levels
Serial serum assessments from baseline up to 15 days
Measured: 15 days
Viral load analyses
Serial assessments from baseline up to 15 days for viral load persistence
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start15 May 2020 (estimated)
- Primary completion15 Sep 2020 (estimated)
- Study completion15 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof-of-concept trial with an exploratory single-arm proof of concept Phase IIa study
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlomaurizio Montecucco, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Carlomaurizio Montecucco, Prof, Principal investigator, Rheumatology, IRCCS Fondazione Policlinico S. Matteo, Pavia, ItalyRaffaele Bruno, Prof, Study chair, Infectious Diseases; IRCCS Fondazione Policlinico S. Matteo, Pavia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399798
- Sponsor's protocol ID
- 2020-001185-11
- Acronym
- BREATH
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32032529Stebbing 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.
PubMed 32113509
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A proof-of Concept Study of the Use of Janus Kinase 1 and 2 Inhibitor, Baricitinib, in the Treatment of COVID-19-related Pneumonia
- ClinicalTrials.gov ID
- NCT04399798
- Acronym / sponsor ID
- BREATH / 2020-001185-11
- Conditions
- Corona Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 15 May 2020 (estimated)
- Primary completion
- 15 Sep 2020 (estimated)
- Study completion
- 15 Nov 2020 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof-of-concept trial with an exploratory single-arm proof of concept Phase IIa study
| Arm | Type | Receives |
|---|---|---|
| Baricitinib active treatment | Experimental | Drug: BaricitinibBaricitinib 4 mg/day |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibAlso: Olumiant4 mg/day for 7 days | Drug | Baricitinib active treatment |
Primary outcome
Response to treatment: absence of moderate to severe oxygenation impairment (Berlin criteria)
Time frame: 8 days
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)
Response to treatment: survival
Time frame: 8 days
Absence of death within 8 days from enrollment
13 secondary outcomes
To quantify the rate of each of: moderate or severe oxygenation impairment within 8 days
Time frame: 8 days
To quantify the rate of each of: moderate or severe oxygenation impairment within 15 days
Time frame: 15 days
Mortality
Time frame: 8 days and 15 days
Peripheral capillary oxygen saturation (SpO2)
Time frame: 8 days; 15 days
Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2)
Time frame: 8 days; 15 days
To assess the rate of patients admitted to the intensive care unit
Time frame: 8 days; 15 days
To measure the length of hospital stay
Time frame: 8 days; 15 days
28-day mortality
Time frame: 28 days
To quantify the rate of re-admission within 28 days
Time frame: 28 days
To quantify the cumulative incidence and severity of adverse events
Time frame: 28 days
Interleukin (IL)-1; IL-2; IL-10; IL-6; IL-8; IL-17; IL-2 receptor levels;
Time frame: 15 days
TNFalpha; vascular endothelial growth factor (VEGF); interferon gamma (IFNgamma) levels
Time frame: 15 days
Viral load analyses
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Background: PubMed 32032529Richardson 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.
- Background: PubMed 32113509Stebbing 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlomaurizio Montecucco, Prof principal investigator
Rheumatology, IRCCS Fondazione Policlinico S. Matteo, Pavia, Italy
Raffaele Bruno, Prof study chair
Infectious Diseases; IRCCS Fondazione Policlinico S. Matteo, Pavia, Italy
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib in people with Corona Virus Infection, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Monti, MD (0382501878, sara.saramonti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment: absence of moderate to severe oxygenation impairment (Berlin criteria) (time frame: 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04399798, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.