Table 1.
JAK/STAT inhibitors COVID-19 randomized clinical trials information.
| Clinical identifier/Status | Sponsor | Population | Intervention | Control group | Primary outcome |
|---|---|---|---|---|---|
| NCT04421027 (phase III, completed) | Eli Lilly and Company | N = 1585 | Baricitinib (orally) | Placebo | Mortality, needing mechanical ventilation or ECMO |
| NCT04970719 (phase III, recruiting) | Bangladesh Institute of Research and Rehabitation in Diabetes, Endocrine, and Metabolic Disorders | N = 382 | Baricitinib (orally) | Remdesivir (IV) plus dexamethasone | requiring “rescue treatment” |
| NCT05056558 (phase III, not yet recruiting) | Incepta Pharmaceuticals Ltd | N = 480 | Baricitinib (orally) | Placebo | Clinical status assessed by a 7-point ordinal scale on Day 14: (mortality, hospitalization’ needing mechanical ventilation or ECMO) |
| NCT05082714 (phase: not applicable, recruiting) | University Hospital of Patras | N = 164 | Baricitinib (orally) plus usual care versus tocilizumab (IV) plus usual care | – | Mortality and mechanical ventilation |
| NCT04693026 (phase III, recruiting) | M Abdur Rahim Medical College and Hospital | N = 150 | Remdesivir (IV) plus baricitinib (orally) | Remdesivir (IV) plus tocilizumab (IV) | Time for clinical improvement |
| NCT04832880 (phase III, not yet recruiting) | ASST Fatebenefratelli Sacco | N = 4000 | Remdesivir (IV) plus dexamethasone (IV)/baricitinib (orally) plus dexamethasine (IV) | Control arm: dexamethasone arm (IV)/remdesivir (IV) plus baricitinib (IV) plus dexamethasone (IV) | Mortality or respiratory failure |
| NCT04393051 (phase II, not yet recruiting) | Azienda Ospedaliero, Universitaria Pisana | N = 126 | Baricitinib (orally) | Standard of care | Mechanical ventilation |
| NCT04346147 (phase II, active, not recruiting) | Hospital Universitario de Fuenlabrada | N = 168 | Imatinib (orally)/baricitinib (orally) | Supportive treatment | Time for clinical improvement |
| NCT04401579 (phase III, completed) | National Institute of Allergy and Infectious Diseases (NIAID) | N = 1033 | Remdesivir (IV) plus baricitinib (orally) | Remdesivir (IV) plus placebo | Time to recovery, time to hospitalization, and needing supplemental oxygen |
| NCT04640168 (phase III, completed) | National Institute of Allergy and Infectious Diseases (NIAID) | N = 1010 | Baricitinib (orally) plus remdesivir (IV) plus dexamethasone (IV) | Dexamethasone (IV) plus placebo plus remdesivir (IV) | Death, hospitalization, needing mechanical ventilation or ECMO |
| NCT04390464 (phase IV, recruiting) | Cambridge University Hospitals NHS Foundation Trust | N = 1167 | Baricitinib (orally) plus standard care/ravulizumab (IV) plus standard care | Standard care | Mortality, needing mechanical ventilation, ECMO or cardiovascular organ support, renal failure |
| NCT04891133 (phase II and III, recruiting) | Oslo University Hospital | N = 1900 | Baricitinib (orally) | Placebo | Mortality, disease progression, SpO2/FiO2-ratio |
| NCT04890626 (phase III, recruiting) | Instituto de Investigación Hospital Universitario La Paz | N = 2193 | Main randomization.Arm: Emtricitabine/Tenofovir disoproxil fumarate Emtricitabine/Tenofovir disoproxil fumarate/Rescue randomization: Arm: Dexamethasone (IV) + Baricitinib (orally)/Arm: Dexamethasone (IV) |
No Intervention: Main randomization.Arm: No treatment | Mortality rate |
| NCT04381936 (phase II and III, recruiting) | University of Oxford | N = 50,000 | Baricitinib (orally) but not limited to it (Lopinavir-Ritonavir, Corticosteroid, and 13 other medications) | Standard care | Mortality rate |
| NCT05187793 (phase III, recruiting) | R-Pharm | N = 204 | Olokizumab (IV) plus standard therapy (baricitinib (orally), favipiravir (orally), dexamethasone (IV) | Standard therapy (baricitinib (orally), favipiravir (orally), dexamethasone (IV) | Clinical recovery |
| NCT04469114 (phase III, completed) | Hospital Israelita Albert Einstein (Pfizer) | N = 289 | Tofacitinib (orally) | placebo | Death, mechanical ventilation, or ECMO |
| NCT04469114 (phase III, completed) | Hospital Israelita Albert Einstein (collaborator: Pfizer) | N = 289 | Tofacitinib (orally) | placebo | Death, mechanical ventilation, or ECMO |
| NCT04390061 (phase II, not yet recruiting) | Università Politecnica delle Marche | N = 116 | Tofacitinib (orally) | Standard care (Hydroxychloroquine (orally)) | Prevention of severe respiratory failure and requiring mechanical ventilation |
| NCT05080218 (phase IV, not yet recruiting) | Jeffrey Curtis | N = 1000 | Tofacitinib (orally)/Upadacitinib/Abatacept and 3 other types of medications | No, Intervention: treatment continuation treatment continuation of all immunomodulatory therapy at the time of COVID vaccine booster (mRNA vaccine dose 3) | Quantitative ratio post booster vs. pre-booster of IgG against SARS-CoV-2 using electrochemiluminescent (ECL) technology against the receptor-binding domain (RBD) of spike protein, stratified by treatment arm |
| NCT04362137 (phase III, completed) | Novartis Pharmaceuticals | N = 432 | Ruxolitinib (orally) | placebo | Mortality, respiratory failure, ICU admission |
| NCT04424056 (phase III, not yet recruiting) | Assistance Publique Hopitaux De Marseille | N = 216 | Administration of Anakinra ± ruxolitinib (orally) in the severe stage/Tocilizumab ± ruxolitinib (orally) in the severe stage | Standard care in sever stage | Ventilation free days |
| NCT04403243 (phase II, recruiting) | Lomonosov Moscow State University Medical Research and Educational Center | N = 70 | Arm1: Colchicine (orally)/Arm2:ruxolitinib (orally)/Arm 3: Secukinumab (subcutaneously) | Standard therapy | Changes in clinical status: respiratory rate, body temperature, Sp02 without support oxygen, ventilation, CRP, D-dimer, exposure area on lung CT |
| NCT04581954 (phase I and II, recruiting) | Imperial College London | N = 456 | Fostamatinib (orally)/ruxolitinib (orally) | Standard care | Mortality, needing mechanical ventilation |
| NCT04348695 (phase II, recruiting) | Fundación de investigación HM | N = 94 | Ruxolitinib (orally) | Standard care | Respiratory failure |
| NCT04348695 (phase II, recruiting) | Fundación de investigación HM | N = 94 | Ruxolitinib (orally) plus simvastatin (orally) | Standard care | Respiratory failure |