Baricitinib Therapy in COVID-19
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ClinicalTrials.gov Identifier: NCT04358614 |
Recruitment Status :
Completed
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
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Condition or disease | Intervention/treatment | Phase |
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COVID Pneumonia | Drug: Baricitinib 4 MG Oral Tablet | Phase 2 Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Baricitinib treated patients compared with controls (previously COVID-19 receving standard therapy) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Baricitinib Therapy in COVID-19: A Pilot Study on Safety and Clinical Impact |
Actual Study Start Date : | March 16, 2020 |
Actual Primary Completion Date : | April 5, 2020 |
Actual Study Completion Date : | April 7, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Case patients
Consecutive patients with COVID moderate pneumonia treated with baricitinib tablets 4 mg/day
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Drug: Baricitinib 4 MG Oral Tablet
Baricitinib+antiviral therapy administration for 2 weeks
Other Name: Lopinavir/Ritonavir tablets 250 mg/bid |
Controls
Consecutive patients with COVID moderate pneumonia treated with standard therapy before the date of the first baricitinib-treated patient.
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Drug: Baricitinib 4 MG Oral Tablet
Baricitinib+antiviral therapy administration for 2 weeks
Other Name: Lopinavir/Ritonavir tablets 250 mg/bid |
- 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
- To evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters. [ Time Frame: 2 weeks ]The percentage of patients improving the clinical and respiratory parameters compared with controls.
- ICU admission rate [ Time Frame: 2 weeks ]The percentage of ICU admission in baricitinib group as compared with controls.
- Discharge rate. [ Time Frame: 2 weeks ]The percentage of discharged in baricitinib group as compared with controls.

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Transaminases values 4-fold higher than the upper normal limit.
- HBV and HCV positivity.
- Current Herpes zoster infection.
- Evidence of concomitant bacterial infections.

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): NCT04358614
Italy | |
Fabrizio Cantini | |
Prato, Tuscany, Italy, 59100 |
Responsible Party: | Fabrizio Cantini, MD, Head of Rheumatology Department, Principal investigator, Hospital of Prato |
ClinicalTrials.gov Identifier: | NCT04358614 |
Other Study ID Numbers: |
HPrato-4 |
First Posted: | April 24, 2020 Key Record Dates |
Last Update Posted: | April 24, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 BARICITINIB MODERATE DISEASE |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Ritonavir |
Lopinavir HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |