Table 4.
Randomized controlled clinical trials with agents targeting the IL-6 signalling in COVID-19 that are ongoing or awaiting results (as reported in Clinicaltrials.gov; last accessed December 6, 2021).
| Trial ID | Name | Phase | Masking | Recruitment Status | Actual (or Estimated) Completion Date | Actual (or Estimated) Number of Patients Enrolled | (Main)Location | Experimental Intervention(s) | Comparator(s) |
|---|---|---|---|---|---|---|---|---|---|
| NCT04479358 | COVIDOSE-2 | II | open-label | recruiting | March 2023 | (332) | USA | low-dose tocilizumab (40 or 120 mg) | standard-dose tocilizumab or SOC |
| NCT04412772 | ARCHITECTS | III | double-blind | recruiting | December 2021 | (300) | USA | tocilizumab | placebo |
| NCT04377750 | IV | open-label | recruiting | (May 2021) | (500) | Israel | tocilizumab | placebo | |
| NCT05002517 | III | triple-blind | active, not recruiting | (October 2021) | 60 | Spain | tocilizumab | methylprednisolone | |
| NCT04519385 | N/A | double-blind | completed | August 2020 | 69 | Egypt | tocilizumab | dexamethasone | |
| NCT04476979 | TOCIDEX | II | open-label | recruiting | December 2021 | (660) | French Guiana | tozilizumab + dexamethasone | dexamethasone |
| NCT04577534 | COVIDSTORM | III | open-label | completed | June 2021 | 88 | Finland | tocilizumab | SOC |
| NCT04690920 | N/A | open-label | completed | December 2020 | 200 | Pakistan | tocilizumab or remdesivir | SOC | |
| NCT04412291 | ImmCoVA | II | open-label | recruiting | (June 2021) | (120) | Sweden | tocilizumab or anakinra (+ SOC) | SOC |
| NCT04678739 | III | open-label | completed | February 2021 | 205 | Bangladesh | tozilizumab + remdesivir | SOC | |
| NCT04409262 | REMDACTA | III | double-blind | completed | March 2021 | 649 | USA | tocilizumab + remdesivir | placebo + remdesivir |
| NCT04779047 | IV | open-label | recruiting | (April 2021) | (150) | Egypt |
tocilizumab + remdesivir
+ lopinavir/ritonavir |
tocilizumab + ivermectin
+ hydroxychloroquine |
|
| NCT04310228 | N/A | open-label | recruiting | (May 2020) | (150) | China | tocilizumab + favipiravir | tocilizumab or favipiravir | |
| NCT04424056 | III | open-label | not yet recruiting | November 2022 | (216) | France | tocilizumab or anakinra ± ruxolitinib | SOC | |
| NCT04330638 | COV-AID | III | open-label | completed | April 2021 | 342 | Belgium | tocilizumab or siltuximab or anakinra or tocilizumab + anakinra or siltuximab + anakinra |
SOC |
| NCT04600141 | HEPMAB | III | open-label | recruiting | December 2021 | (308) | Brazil |
tocilizumab + heparin
(therapeutic or prophylactic anticoagulation with UFH or LMWH) |
heparin (therapeutic or prophylactic, UFH or LMWH) |
| NCT05118737 | I | open-label | recruiting | August 2022 | (230) | Qatar | tocilizumab + colchicine | tocilizumab | |
| NCT04335305 | COPERNICO | II | open-label | recruiting | (June 2021) | (24) | Spain | tocilizumab + pembrolizumab | SOC |
| NCT04347031 | II/III | open-label | completed | November 2020 | 320 | Russia |
mefloquine or hydroxychloroquine + azithromycin ± tocilizumab |
mefloquine or hydroxychloroquine | |
| NCT04346693 | III | open-label | completed | November 2020 | 320 | Russia |
leitragin (intramuscular or inhaled) + hydroxychloroquine + azithromycin ± tocilizumab |
hydroxychloroquine + azithromycin ± tocilizumab | |
| NCT04357860 | SARICOR | II | open-label | completed | April 2021 | 120 | Spain | sarilumab sc (200 or 400 mg) (+ SOC) | SOC |
| NCT04357808 | SARCOVID | II | open-label | completed | December 2020 | 30 | Spain | sarilumab sc (+ SOC) | SOC |
| NCT04359901 | II | open-label | active, not recruiting | April 2023 | 50 | USA | sarilumab sc (+ SOC) | SOC | |
| NCT04324073 | CORIMUNO-SARI | II/III | open-label | active, not recruiting | December 2021 | 239 | France | sarilumab | SOC |
| NCT04329650 | II | open-label | recruiting | (May 2020) | (200) | Spain | siltuximab | methylprednisolone | |
| NCT04343989 | II | double-blind | completed | March 2021 | 180 | USA | clazakizumab (25 mg or 12.5 mg) | placebo | |
| NCT04363502 | II | triple-blind | recruiting | May 2022 | (30) | USA | clazakizumab | placebo | |
| NCT04494724 | II | quadruple-blind | recruiting | (July 2021) | (60) | USA | clazakizumab | placebo | |
| NCT04380961 | II | quadruple-blind | completed | June 2021 | 212 | USA | sirukumab (+ SOC) | placebo (+ SOC) | |
| NCT04380519 | II/III | double-blind | completed | July 2020 | 372 | Russia | olokizumab or RPH-104/goflikicept (+ SOC) | placebo (+ SOC) | |
| NCT05056558 | III | triple-blind | not yet recruiting | September 2022 | (480) | Bangladesh | baricitinib (+ SOC) | placebo (+ SOC) | |
| NCT04891133 | EU SolidAct | II/III | quadruple-blind | recruiting | September 2025 | (1900) | Austria | baricitinib (+ SOC) | placebo (+ SOC) |
| NCT04346147 | Covid19 COVINIB |
II | open-label | active, not recruiting | (September 2021) | 168 | Spain | baricitinib or imatinib | supportive treatment |
| NCT04390464 | TACTIC-R | IV | open-label | recruiting | May 2022 | (1167) | UK | baricitinib or ravulizumab (+ SOC) | SOC |
| NCT04970719 | III | open-label | recruiting | December 2021 | (382) | Bangladesh | baricitinib + remdesivir | dexamethasone + remdesivir | |
| NCT04832880 | AMMURAVID | III | open-label | not yet recruiting | December 2022 | (4000) | Italy | baricitinib + remdesivir + dexamethasone or baricitinib + dexamethasone or remdesivir + dexamethasone |
dexamethasone |
| NCT04640168 | ACTT-4 | III | double-blind | completed | June 2021 | 4074 | USA | baricitinib + remdesivir + placebo | placebo + remdesivir + dexamethasone |
| NCT04403243 | COLORIT | II | open-label | recruiting | (August 2020) | (70) | Russia | ruxolitinib or colchicine or secukinumab | SOC |
| NCT04581954 | MATIS | I/II | single-blind | recruiting | December 2021 | (456) | UK | ruxolitinib or fostamatinib | SOC |
| NCT04348695 | Ruxo-Sim-20 | II | open-label | recruiting | (May 2020) | (94) | Spain | ruxolitinib + simvastatin | SOC |
| NCT05082714 | N/A | open-label | recruiting | April 2022 | (164) | Greece | tocilizumab | baricitinib | |
| NCT04693026 | III | open-label | recruiting | (March 2021) | (150) | Bangladesh | tocilizumab + remdesivir | baricitinib + remdesivir |
SOC, standard-of-care; UFH, unfractionated heparin; LMWH, low-molecular-weight heparin.
Bold text indicates completed studies awaiting results with a relevant number of participants or testing additional IL-6 inhibitors, interesting combinations or comparations.