Baricitinib Therapy in COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-16

Study Completion Date

2020-04-07

Brief Summary

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

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Detailed Description

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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.

Conditions

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COVID Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Case patients

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

Group Type ACTIVE_COMPARATOR

Baricitinib 4 MG Oral Tablet

Intervention Type DRUG

Baricitinib+antiviral therapy administration for 2 weeks

Controls

Consecutive patients with COVID moderate pneumonia treated with standard therapy before the date of the first baricitinib-treated patient.

Group Type OTHER

Baricitinib 4 MG Oral Tablet

Intervention Type DRUG

Baricitinib+antiviral therapy administration for 2 weeks

Interventions

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Baricitinib 4 MG Oral Tablet

Baricitinib+antiviral therapy administration for 2 weeks

Intervention Type DRUG

Other Intervention Names

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Lopinavir/Ritonavir tablets 250 mg/bid

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No