NCT04320277: BARI-COVID

Baricitinib in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study.

Status unknown Phase 2, PHASE3 Last updated 22 April 2020

What this trial tests

Phase 2, PHASE3 trial testing Baricitinib in Pharmacological Action in 200 participants. Status unknown.

Timeline

16 May 2020

Primary endpoint
30 June 2020

30 July 2020

Quick facts

Lead sponsor	Hospital of Prato
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	16 May 2020
Primary completion	30 June 2020
Estimated completion	30 July 2020
Sites	1 location across Italy

Drugs / interventions tested

• Baricitinib (baricitinib) — full drug profile →

Conditions studied

• Pharmacological Action — all drugs for Pharmacological Action →

Sponsor

Hospital of Prato

Who can join

Adults 18 to 85, any sex, with Pharmacological Action. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is no specific antiviral treatment recommended for COVID-19, and no vaccine is currently available. Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2. The drug was found capable to reduce or interrupt the passage of the virus into target cells, and to inhibit the JAK1- and JAK2-mediated cytokine release. The drug was licensed for the treatment of rheumatoid arthritis at the daily dose of 4 mg/orally, with excellent results in terms of clinical response and a good safety profile. Since baricitinib does not interact with antivirals due to its prevalent renal elimination, it may be used in combination.The evidence on the advantageous action of baricitinib on viral entry and cytokine outbreak constituted the rationale to perform a trial on patients with mild to moderate COVID-19 infection receiving baricitinib combined with antiviral therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pathological inflammation in patients with COVID-19: a key role for monocytes and macrophages.
   Merad M, Martin JC. · · 2020 · cited 1909× · PMID 32376901 · DOI 10.1038/s41577-020-0331-4
2. Cytokine storm and leukocyte changes in mild versus severe SARS-CoV-2 infection: Review of 3939 COVID-19 patients in China and emerging pathogenesis and therapy concepts.
   Wang J, Jiang M, Chen X, Montaner LJ. · · 2020 · cited 551× · PMID 32534467 · DOI 10.1002/jlb.3covr0520-272r
3. On the Alert for Cytokine Storm: Immunopathology in COVID-19.
   Henderson LA, Canna SW, Schulert GS, Volpi S, et al · · 2020 · cited 487× · PMID 32293098 · DOI 10.1002/art.41285
4. Should we stimulate or suppress immune responses in COVID-19? Cytokine and anti-cytokine interventions.
   Jamilloux Y, Henry T, Belot A, Viel S, et al · · 2020 · cited 486× · PMID 32376392 · DOI 10.1016/j.autrev.2020.102567
5. COVID-19: Transmission, prevention, and potential therapeutic opportunities.
   Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044
6. The impact of the COVID-19 pandemic on cancer care.
   Richards M, Anderson M, Carter P, Ebert BL, et al · · 2020 · cited 359× · PMID 35121972 · DOI 10.1038/s43018-020-0074-y
7. COVID-19, immune system response, hyperinflammation and repurposing antirheumatic drugs
   Tufan A, Avanoğlu Güler A, Matucci-Cerinic M. · · 2020 · cited 270× · PMID 32299202 · DOI 10.3906/sag-2004-168
8. Patients with COVID-19: in the dark-NETs of neutrophils.
   Ackermann M, Anders HJ, Bilyy R, Bowlin GL, et al · · 2021 · cited 235× · PMID 34031543 · DOI 10.1038/s41418-021-00805-z