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. 2022 Jul 3;202:115162. doi: 10.1016/j.bcp.2022.115162

Table 2.

Clinical trials investigating Baricitinib in treatment of COVID-19.

Clinical trial identifier Status Study design No of enrolled Age(y) Treatment Outcomes
NCT04401579 Completed double-blind, randomized, placebo-controlled trial (ACTT-2) 1033 18–99 Baricitinib (4 mg/d) + RDV vs. Placebo + RDV Time to recovery
NCT04390464 Recruiting Randomized, parallel arm, open-label (TACTIC-R) 1167 18 ∼ Baricitinib (4 mg/d) + SOC

vs. Ravulizumab + SOC
Time to the incidence of the composite endpoint of: death, mechanical ventilation, cardiovascular organ
NCT04358614 Completed Interventional 12 12–85 Baricitinib-4 mg/d To assess the safety of Baricitinib combined with antiviral (lopinavir-ritonavir) in terms of serious or non-serious adverse events incidence rate.
NCT04362943 Completed Retrospective, observational,

single-center cohort study
576 70∼ Baricitinib

vs. Anakinra
All-cause mortality
NCT04346147 Active, not recruiting Randomized, single-center,

parallel assignment, open-label
168 18∼ Hydroxychloroquine + one of:
Baricitinib
(4 mg/d × 7 days)
or Lopinavir/ritonavir
or Imatinib
Time to clinical improvement on 7-point ordinal scale
NCT04320277 Not yet recruiting Non randomized, before-after,

single-center
200 18∼ Baricitinib (4 mg/d x14 days) + antiviral

vs. antiviral and/or hydroxychloroquine
ICU transfer
NCT04373044 Terminated Prospective, single-arm, two center, open label 6 18∼ Baricitinib (4 mg/d × 14 days)

+ one of:
Hydroxychloroquine or Lopinavir/ritonavir/Remdesivir
Death or mechanical ventilation at day 14
NCT04321993 Recruiting Non randomized, multi-center,

parallel assignment, open label
800 18∼ Baricitinib (2 mg/d x10 days)

vs. SOC
Clinical improvement on 7-point ordinal scale at day 15
NCT04421027 Completed Randomized, double-Blind, placebo controlled, parallel
assignment, interventional
(COV-BARRIER)
1585 18∼ Baricitinib-4 mg/d vs. placebo Cases needing: non-invasive ventilation, high-flow oxygen, invasive mechanical ventilation
NCT04393051 Not yet recruiting Randomized, multicentered, open-label, parallel assignment, interventional 126 18∼ Baricitinib- 4 mg or 2 mg/d for 14 days.

vs. SOC
The decrease in patients requiring invasive ventilation
NCT04399798 Not yet recruiting Single group, assignment, open-label, interventional 13 18–74 Baricitinib-4 mg/d for 7 days Response to treatment: absence of moderate to severe oxygenation impairment
NCT04365764 Recruiting Cross sectional, case control, observational 400 no limit Treatment including Baricitinib

vs. patients are not given treatment.
Composite of death and mechanical ventilation.
NCT04366206 Recruiting Prospective, cohort, observational 143 no limit Treatment including Baricitinib

vs. patients are not exposed to treatment or risk factor
Composite of death and mechanical ventilation
NCT04970719 Recruiting Interventional, randomized, parallel, assignment 382 18∼ Baricitinib

vs. Dexamethasone
vs. Remdesivir
Rescue treatment
NCT04640168 Active, not

recruiting
Randomized, parallel

assignment, interventional (ACTT-4)
1010 18–99 Baricitinib

Dexamethasone
Placebo
Remdesivir
The proportion of subjects not meeting criteria for one of the following two ordinal scale categories at any time: death; hospitalized, on invasive mechanical ventilation or

ECMO
NCT04381936 Recruiting Randomized, controlled, open-label platform trial (RECOVER) 8156 no limit Baricitinib 4 mg/d for 10 days vs. UC 28-day mortality

VDR = remdesivir; SOC = standard of care; ICU = intensive care unit; ECMO = extracorporeal membrane oxygenation.