Trial identifier | Study design | Agent(s) and comparison (if any) | Patient population | Outcome measures |
Anakinra | ||||
ANA-COVID-GEAS (NCT04443881) | Phase II/III open-label, randomized, parallel group, 2-arm | Anakinra vs SOC | One or more:
| 15-day MV Need for MV O2 sat normalization ICU |
Early Treatment of Cytokine Storm Syndrome in COVID-19 (NCT04362111) | Phase III, randomized, triple-masked, dual arm | Anakinra vs placebo | Chest imaging studies consistent with COVID-19 pneumonia Hyperferritinemia (>700 ng/mL) Fever >38°C Any three of:
| 28-day percentage of patients discharged from the hospital alive and without the need for MV Percentage of subjects discharged from hospital without the need for intubation and mechanical ventilation |
Anakinra in the Management of COVID-19 Infection (NCT04643678) | Phase III, open-label | Anakinra vs SOC |
| 14-day treatment success defined as WHO Clinical Progression Score of <6 (patient alive, not requiring invasive, non-invasive, or high flow oxygen therapy, vasopressors, dialysis or (ECMO)) |
Baricitinib | ||||
A Study of Baricitinib (LY3009104) in Participants With COVID-19 (COV-BARRIER) (NCT04421027) | Phase III, randomized, triple-masked | Baricitinib vs placebo |
| Percentage of participants who die or require non-invasive ventilation/high-flow O2 or invasive MV (including ECMO) |
Baricitinib, Placebo and Antiviral Therapy for the Treatment of Patients With Moderate and Severe COVID-19 (NCT04373044) | Phase II, randomized, double-blind | Baricitinib vs placebo |
| 14-day proportion of patients requiring invasive mechanical ventilation or dying |
Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients (NCT04321993) | Phase II, open-label | Baricitinib vs SOC |
| Clinical status of subject at day 15 (on 7 point ordinal scale) |
Adaptive COVID-19 Treatment Trial 4 (ACTT-4) (NCT04640168) | Phase III, randomized, double-masked | Baricitinib +remdesevir vs remdesevir +dexamethasone |
| Proportion who die or are hospitalized on invasive mechanical ventilation or ECMO |
*Trials that were terminated per investigator discretion or for other reasons including lack of funding or not meeting accrual not included in this table.
ALT, alanine transaminase; AST, aspartate transaminase; CRP, C reactive protein; ICU, intensive care unit; IL, interleukin; LDH, lactate dehydrogenase; SOC, standard of care; ULN, upper limit of normal.