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.