Baricitinib Therapy in COVID-19

NCT04358614 | Completed Phase 2

• 1 other identifier: HPrato-4
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective study on the efficacy of baricitinib in 12 COVID-19 patients with moderate pneumonia.

Conditions

COVID; Pneumonia

Keywords

COVID-19; BARICITINIB; MODERATE DISEASE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters.

  2 weeks

• ICU admission rate

  2 weeks

• Discharge rate.

  2 weeks

Study Arms (2)

Case patients

ACTIVE COMPARATOR

Consecutive patients with COVID moderate pneumonia treated with baricitinib tablets 4 mg/day

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.

Drug: Baricitinib 4 MG Oral Tablet

Interventions

Baricitinib 4 MG Oral Tablet DRUG

Baricitinib+antiviral therapy administration for 2 weeks

Also known as: Lopinavir/Ritonavir tablets 250 mg/bid

Case patients; Controls

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fabrizio Cantini: lead

Study Sites (1)

Fabrizio Cantini

Prato, Tuscany, 59100, Italy

Location

Related Publications (5)

• 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.

  PMID: 11877461 BACKGROUND

• Ferner RE, Aronson JK. Chloroquine and hydroxychloroquine in covid-19. BMJ. 2020 Apr 8;369:m1432. doi: 10.1136/bmj.m1432. No abstract available.

  PMID: 32269046 BACKGROUND

• 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

• 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. doi: 10.1093/qjmed/94.10.521.

  PMID: 11588210 BACKGROUND

MeSH Terms

Conditions

Pneumonia; COVID-19

Interventions

baricitinib; Lopinavir; Ritonavir; BID protein, human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Head of Rheumatology Department, Principal investigator

Model Details: Baricitinib treated patients compared with controls (previously COVID-19 receving standard therapy)

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 24, 2020
• Study Start: March 16, 2020
• Primary Completion: April 5, 2020
• Study Completion: April 7, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)