Table 3.
Clinical trials investigating Ruxolitinib in treatment of COVID-19.
| Clinical trial identifier | Status | Study design | No. of enrolled | Age(y) | Treatment | Outcomes |
|---|---|---|---|---|---|---|
| ChiCTR2000029580 | Completed | Single blind, randomized, parallel assignment | 35 | 18–75 | Ruxolitinib (5 mg bid) vs. placebo | Mortality; mechanical ventilation; duration of hospital stay; duration of ventilation; time to symptom or clinical improvement; time to viral clearance |
| NCT04338958 | Completed | Single arm, non-randomized, interventional | 105 | 18 ∼ | Ruxolitinib-10 mg bid increased to 20 mg bid for 7 days | Overall response rate in reversal of hyperinflammation |
| NCT04334044 | Completed | Single group assignment, open-label, interventional | 77 | 18 ∼ | Ruxolitinib- 5 mg bid | Recovery from pneumonia |
| NCT04377620 | Terminated | Randomized, double-blinded, placebo-controlled, multicentered, interventional | 211 | 12∼ | Ruxolitinib (5 mg bid) vs. Ruxolitinib (15 mg bid) + SOC | Proportion of participants who have died due to any cause |
| NCT04414098 | Not yet recruiting | Experimental, open-label prospective, single centered, add-on, interventional |
100 | 18∼ | Ruxolitinib- 5 mg bid up to 14 days and taken orally | Evaluation of Ruxolitinib efficiency in COVID-19 treatment |
| NCT04366232 | Terminated | Randomized, open label, parallel assignment, interventional | 2 | 18∼ | Ruxolitinib (5 mg bid up to 28 days + Anakinra vs. Anakinra vs. SOC |
CRP, Ferritinemia, Serum creatinine, AST/ALT, Eosinophils |
| NCT04362137 | Completed | Randomized, double-blind, placebo-controlled, multicentered, interventional | 432 | 12∼ | Ruxolitinib- 5 mg bid for 14–28 days vs. placebo |
Proportion of patients who die, develop respiratory failure [require mechanical ventilation] or require ICU care |
| NCT04331665 | Terminated | Single arm, open-label, interventional | 3 | 12∼ | Ruxolitinib-10 mg bid x14days following this, 5 mg bid × 2 days and then 5 mg, qd × 1 day | The proportion of ill patients with COVID-19 pneumonia who become critically ill the number of adverse events |
| NCT04361903 | Not yet recruiting | Cohort, retrospective, monocentric, non-profit observational |
18 | 18∼ | Ruxolitinib-20 mg bid in the first 48 h. | Patients avoiding mechanically assisted ventilation in ARDS occurring in COVID-19 patients |
| NCT04424056 | Not yet recruiting | Open-label, randomized, parallel assignment, interventional | 216 | 18–75 | Anakinra and Ruxolitinib vs. Tocilizumab and Ruxolitinib vs. SOC |
The number of days without mechanical ventilation at day 28 |
| NCT04374149 | Completed | Non-randomized, sequential assignment, open-label, interventional | 20 | 12–80 | Ruxolitinib (5 mg bid x14days) + TPE vs. TPE | CRP levels at baseline and day 14, cytokine levels at baseline and day 14 |
| NCT04359290 | Completed | Single group assignment, open-label, interventional | 15 | 18∼ | Ruxolitinib-10 mg bid (day1) up to 15 mg bid (day2-8) | Overall survival of COVID-19 patients |
| NCT04477993 | Terminated | Randomized, double-blind, parallel assignment, interventional (RUXO-COVID) | 5 | 18–95 | Ruxolitinib- 5 mg bid at days 0–14 vs. Placebo | Death, ICU admission, mechanical ventilation at day 14 |
| NCT04403243 | Recruiting | Randomized, open-label, parallel assignment, interventional | 70 | 18∼ | Colchicine vs. Ruxolitinib 5 mg vs. Secukinumab 150 mg/ml subcutaneous solution [COSENTYX] vs. standard therapy |
Change from baseline in clinical assessment score COVID 19 (CAS COVID 19) frame: baseline |
| NCT04348695 | Recruiting | Randomized, open-label, parallel assignment, interventional | 94 | 18∼ | Ruxolitinib-5 mg bid × 7 days and 10 mg bid for up to 14 days vs SOC | Cases developing severe respiratory failure |
| NCT04351503 | Recruiting | Retrospective, observational | 10,000 | no limit | Current treatments including Ruxolitinib | Identification of factors associated with infection, hospitalization, and requirement of ICU treatment |
| NCT04278404 | Recruiting | Prospective, observational | 5000 | ∼20 | Under studied drugs including Ruxolitinib | Clearance, half-life, volume of distribution, elimination rate constant, half-life |
| NCT04581954 | Recruiting | Randomized, parallel assignment, interventional |
456 | 18∼ | Ruxolitinib vs. Fostamatinib vs. SOC |
All-cause mortality |
SOC = standard of care; COVID-19 = coronavirus disease 2019; CRP = C-reactive protein; AST = aspartate transaminase; ALT = alanine transaminase; ICU = intensive care unit; ARDS = acute respiratory distress syndrome; TPE = therapeutic plasma exchange.