Pneumonia Clinical Trial
Official title:
Baricitinib Therapy in COVID-19: A Pilot Study on Safety and Clinical Impact
Verified date | April 2020 |
Source | Hospital of Prato |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Retrospective study on the efficacy of baricitinib in 12 COVID-19 patients with moderate pneumonia.
Status | Completed |
Enrollment | 12 |
Est. completion date | April 7, 2020 |
Est. primary completion date | April 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Fabrizio Cantini | Prato | Tuscany |
Lead Sponsor | Collaborator |
---|---|
Fabrizio Cantini |
Italy,
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. Epub 2002 Mar 4. — View Citation
Ferner RE, Aronson JK. Chloroquine and hydroxychloroquine in covid-19. BMJ. 2020 Apr 8;369:m1432. doi: 10.1136/bmj.m1432. — View Citation
Richardson P, Griffin I, Tucker C, Smith D, Oechsle O, Phelan A, 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. — View Citation
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. — View Citation
Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2 weeks | |
Secondary | 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. | 2 weeks | |
Secondary | ICU admission rate | The percentage of ICU admission in baricitinib group as compared with controls. | 2 weeks | |
Secondary | Discharge rate. | The percentage of discharged in baricitinib group as compared with controls. | 2 weeks |
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