COVIDPhase 2/3NCT04358614
Baricitinib Therapy in COVID-19
A Phase 2/3 study testing Baricitinib 4 MG Oral Tablet in people with COVID and Pneumonia, run by Fabrizio Cantini at 1 site in Italy.
Trial summary
Retrospective study on the efficacy of baricitinib in 12 COVID-19 patients with moderate pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Baricitinib 4 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 16 Mar 2020to 7 Apr 2020
- Phase
- Phase 2/3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SARS-Co-V2 positivitity to the nasal-swab by reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested by the local diagnostic laboratory
- Age >18 and <85 years
- Presence of at least 3 of the following symptoms as present fever, cough, myalgia, fatigue.
- Presence of radiological findings of pneumonia assessed by chest radiograph, computed tomography, or pulmonary ultrasound.
- Peripheral capillary oxygen saturation (SpO2) > 92% on room air at screening
- PaO2/FiO2 >100-300 mmHg at arterial blood gas analysis.
Who cannot join
- Age < 18 and >85
- History of thrombophlebitis
- Latent tuberculosis infection (based on the positivity to QuantiFERON Plus positivity, Qiagen, Germany)
- Pregnancy and lactation
- History of malignancies over the previous 5 years, current diagnosis of malignancy
- Inability or unwillingness to sign a written consent.
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- Transaminases values 4-fold higher than the upper normal limit.
- HBV and HCV positivity.
- Current Herpes zoster infection.
- Evidence of concomitant bacterial infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Baricitinib Therapy in COVID-19: A Pilot Study on Safety and Clinical Impact
Retrospective study on the efficacy of baricitinib in 12 COVID-19 patients with moderate pneumonia.
Read the detailed description
Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2 that inhibits JAK1- and JAK2-mediated cytokine release, was recently described using BenevolentAI's proprietary artificial intelligence-derived knowledge graph, as an agent that reduces the endocytosis into target cells, and to inhibit the entry. Based on its potential action on inhibition of SARS-CoV-2 entry, and on its known effects on reduction of cytokine release, baricitinib therapy was proposed in patients with moderate pneumonia to explore: the safety of this drug combined with antiviral (lopinavir-ritonavir) in COVID-19; as second outcome, to evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters, and reduction of ICU admission.
Baricitinib was combined with antivirals because it does not interact with them due to its prevalent renal elimination.
- Being tested
- Baricitinib 4 MG Oral Tablet
- Keywords
- COVID-19, BARICITINIB, MODERATE DISEASE
- Medical subject headings
- Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib 4 MG Oral TabletDrug
Also called Lopinavir/Ritonavir tablets 250 mg/bid
Baricitinib+antiviral therapy administration for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Case patients | Active comparator | Consecutive patients with COVID moderate pneumonia treated with baricitinib tablets 4 mg/day Receives: Drug: Baricitinib 4 MG Oral Tablet |
| Controls | Other | Consecutive patients with COVID moderate pneumonia treated with standard therapy before the date of the first baricitinib-treated patient. Receives: Drug: Baricitinib 4 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of baricitinib combined with antiviral (lopinavir-ritonavir) in terms of serious or non-serious adverse events incidence rate.
All adverse event recording
Measured: 2 weeks
Secondary outcomes (3)
To evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters.
The percentage of patients improving the clinical and respiratory parameters compared with controls.
Measured: 2 weeks
ICU admission rate
The percentage of ICU admission in baricitinib group as compared with controls.
Measured: 2 weeks
Discharge rate.
The percentage of discharged in baricitinib group as compared with controls.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start16 Mar 2020
- Primary completion5 Apr 2020
- Study completion7 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Baricitinib treated patients compared with controls (previously COVID-19 receving standard therapy)
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabrizio Cantini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fabrizio Cantini, Hospital of Prato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358614
- Sponsor's protocol ID
- HPrato-4
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conner SD, Schmid SL. Identification of an adaptor-associated kinase, AAK1, as a regulator of clathrin-mediated endocytosis. J Cell Biol. 2002 Mar 4;156(5):921-9. doi: 10.1083/jcb.200108123. Epub 2002 Mar 4.
PubMed 11877461Ferner RE, Aronson JK. Chloroquine and hydroxychloroquine in covid-19. BMJ. 2020 Apr 8;369:m1432. doi: 10.1136/bmj.m1432. No abstract available.
PubMed 32269046Richardson 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 32113509Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.
PubMed 11588210
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baricitinib Therapy in COVID-19: A Pilot Study on Safety and Clinical Impact
- ClinicalTrials.gov ID
- NCT04358614
- Acronym / sponsor ID
- HPrato-4
- Keywords
- COVID-19, BARICITINIB, MODERATE DISEASE
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fabrizio CantiniUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 7 Apr 2020 (actual)
- First posted
- 24 Apr 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.
Retrospective study on the efficacy of baricitinib in 12 COVID-19 patients with moderate pneumonia.
Detailed description
Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2 that inhibits JAK1- and JAK2-mediated cytokine release, was recently described using BenevolentAI's proprietary artificial intelligence-derived knowledge graph, as an agent that reduces the endocytosis into target cells, and to inhibit the entry. Based on its potential action on inhibition of SARS-CoV-2 entry, and on its known effects on reduction of cytokine release, baricitinib therapy was proposed in patients with moderate pneumonia to explore: the safety of this drug combined with antiviral (lopinavir-ritonavir) in COVID-19; as second outcome, to evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters, and reduction of ICU admission.
Baricitinib was combined with antivirals because it does not interact with them due to its prevalent renal elimination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Baricitinib treated patients compared with controls (previously COVID-19 receving standard therapy)
| Arm | Type | Receives |
|---|---|---|
| Case patients | Active comparator | Drug: Baricitinib 4 MG Oral TabletConsecutive patients with COVID moderate pneumonia treated with baricitinib tablets 4 mg/day |
| Controls | Other | Drug: Baricitinib 4 MG Oral TabletConsecutive patients with COVID moderate pneumonia treated with standard therapy before the date of the first baricitinib-treated patient. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- SARS-Co-V2 positivitity to the nasal-swab by reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested by the local diagnostic laboratory
- Age >18 and <85 years
- Presence of at least 3 of the following symptoms as present fever, cough, myalgia, fatigue.
- Presence of radiological findings of pneumonia assessed by chest radiograph, computed tomography, or pulmonary ultrasound.
- Peripheral capillary oxygen saturation (SpO2) > 92% on room air at screening
Key exclusion criteria (10 listed)
- Age < 18 and >85
- History of thrombophlebitis
- Latent tuberculosis infection (based on the positivity to QuantiFERON Plus positivity, Qiagen, Germany)
- Pregnancy and lactation
- History of malignancies over the previous 5 years, current diagnosis of malignancy
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 |
|---|---|---|
| Baricitinib 4 MG Oral TabletAlso: Lopinavir/Ritonavir tablets 250 mg/bidBaricitinib+antiviral therapy administration for 2 weeks | Drug | Case patients, Controls |
Primary outcome
To assess the safety of baricitinib combined with antiviral (lopinavir-ritonavir) in terms of serious or non-serious adverse events incidence rate.
Time frame: 2 weeks
All adverse event recording
3 secondary outcomes
To evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters.
Time frame: 2 weeks
ICU admission rate
Time frame: 2 weeks
Discharge rate.
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Background: PubMed 11877461Conner SD, Schmid SL. Identification of an adaptor-associated kinase, AAK1, as a regulator of clathrin-mediated endocytosis. J Cell Biol. 2002 Mar 4;156(5):921-9. doi: 10.1083/jcb.200108123. Epub 2002 Mar 4.
- Background: PubMed 32269046Ferner RE, Aronson JK. Chloroquine and hydroxychloroquine in covid-19. BMJ. 2020 Apr 8;369:m1432. doi: 10.1136/bmj.m1432. No abstract available.
- 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.
- Background: PubMed 11588210Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Baricitinib 4 MG Oral Tablet in people with COVID and Pneumonia, run by Fabrizio Cantini at 1 site in Italy.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of baricitinib combined with antiviral (lopinavir-ritonavir) in terms of serious or non-serious adverse events incidence rate. (time frame: 2 weeks). 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 NCT04358614, which also lists 5 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 24 Apr 2020.