Table 2.
Ongoing clinical trials of strategies to control cytokine storms in COVID-19.
| Trial identifier | Participants | Trial design | Therapy | Mechanism | Adverse effects |
|---|---|---|---|---|---|
| ChiCTR2000029765 | Adult (18–85 years), moderate/severe/critically ill patients | A multicenter, randomized controlled trial | Tocilizumab vs. Standard medical care |
IL-6 receptor blocker | Infections; skin rash; anemia; neutropenia; lymphopenia; liver enzyme elevations etc. |
| ChiCTR2000030796 | Diagnosed cases | A retrospective study | Tocilizumab | ||
| ChiCTR2000030894 | Adult (18 Years to 65 Years), moderate/severe patients | A multicenter, randomized, controlled trial | Tocilizumab combined with Favipiravir vs. Standard medical care |
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| NCT04332913 | Adult, severe/critically ill patients | A prospective, observational study | Tocilizumab | ||
| NCT04322773 | Adult, severe/critically ill patients | An open-Label, multicenter sequential, cluster randomized trial | Tocilizumab vs. Sarilumab vs. Standard medical care |
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| NCT04317092 | Adult, severe/critically ill patients | A multicenter, single-arm, open-label, phase 2 study | Tocilizumab | ||
| NCT04320615 | Adult, severe/critically ill patients | A randomized, double-blind, placebo-controlled, multicenter, phase 3 trial | Tocilizumab vs. Placebo |
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| NCT04306705 | Adult, severe/critically ill patients | A retrospective study | Tocilizumab vs. Standard medical care vs. Continuous renal replacement therapy |
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| NCT04315480 | Adult, severe/critically ill patients | A phase 2 Simon’s optimal two-stages trial | Tocilizumab | ||
| NCT04335071 | Adult, severe/critically ill patients | A multicenter, double-blind, randomized controlled phase II trial | Tocilizumab vs. Placebo |
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| NCT04324073 | Adult, moderate/severe/critically ill patients | A multiple, open-label, randomized controlled trial | Sarilumab vs. Standard medical care |
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| NCT04315298 | Adult, severe/critically ill patients | An adaptive phase 2/3, randomized, double-blind, placebo-controlled Study | Sarilumab vs. Placebo |
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| NCT04327388 | Adult, severe/critically ill patients | An adaptive phase 3, randomized, double-blind, placebo-controlled trial | Sarilumab vs. Placebo |
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| NCT04341870 | Adult (18–80 years), moderate/severe/critically ill patients | a multicenter open-label 1:1 randomized controlled trial | Sarilumab vs. Azithromycin vs. Hydroxychloroquine |
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| NCT04348500 | Adult patients with pulmonary involvement who have not yet required mechanical ventilation and/or ECMO | A single center, randomized, double-blind, placebo-controlled, exploratory phase II study | Clazakizumab vs. Placebo |
IL- 6 monoclonal antibody | |
| NCT04322188 (66) | Adult, severe/critically ill patients | A single-center observational cohort study | Siltuximab vs. Standard medical care |
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| NCT04329650 | Adult, severe/critically ill patients | A phase 2, randomized, open-label study | Siltuximab vs. methylprednisolone |
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| NCT04318366 (67) | Adult, moderate to severe patients | A retrospective cohort study | Anakinra vs. Standard medical care |
IL-1 receptor antagonist blocking IL-1α and IL-1β | Infections; skin rash; anemia; neutropenia; lymphopenia; liver enzyme elevations etc. |
| NCT04330638 | Adult, severe/critically ill patients | A prospective, randomized, factorial design, interventional Study | Anakinra vs. Tocilizumab vs. Siltuximab vs. Usual Care |
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| NCT04341584 | Adult, severe/critically ill patients | A multiple randomized controlled trial | Anakinra vs. Standard medical care |
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| NCT04339712 | Adult, severe/critically ill patients | A non-randomized, open-label trial | Anakinra vs. Tocilizumab |
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| NCT04365153 (68) | Adult, severe/critically ill patients with cardiac injury | A double-blind, randomized controlled trial | Canakinumab vs. Placebo |
IL-1β monoclonal antibody | |
| NCT04348448 (69) | Adult (18–100 years), severe/critically ill patients | A prospective, observational study | Canakinumab | ||
| ChiCTR2000030089 | Adult, severe/critically ill patients | A randomized, open-label, controlled trial | Adalimumab vs. Standard medical care |
TNF-α inhibitor | Infections; fever; anemia, neutropenia, lymphopenia etc. |
| NCT04324021 (70) | Adult (30–79 years), severe/critically ill patients | An open label, controlled, parallel group, 3-arm, multicenter study | Emapalumab vs. Anakinra vs. Standard medical care |
IFN-γ inhibitor | Serious infections; skin rash; fever; anemia; coagulopathy etc. |
| NCT04358614 | Adult, moderate patients | A phase 2/3, open label, clinical trial | Baricitinib vs. Standard medical care |
JAK1/JAK2 inhibitor | Infections; malignancy; thrombosis: DVT, PE; bleeding; myelofibrosis; anemia, neutropenia, lymphopenia, thrombocytosis, liver enzyme elevations etc. |
| NCT04321993 | Adult, severe/critically ill patients | An open label, non-randomized, parallel group study | Baricitinib vs. Standard medical care |
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| NCT04320277 | Adult (18–85 years), mild/moderate patients | An open label, non-randomized, crossover assignment study | Baricitinib vs. Standard medical care |
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| NCT04346147 | Adult, non-severe patients | A prospective, phase II, randomized, open-label, parallel group study | Baricitinib vs. Hidroxicloroquine vs. Lopinavir/ritonavir vs. Imatinib |
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| NCT04340232 | Adult (18–89 years), without invasive oxygen supplementation | A single arm, open label study | Baricitinib | ||
| NCT04321993 | Adult, severe/critically ill patients | A parallel, open-label, non-randomized intervention trial | Baricitinib vs. Standard medical care |
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| NCT04348695 | Adult, severe patients | A randomized, open label, phase II trial | Ruxolitinib plus simvastatin vs. Standard medical care | ||
| NCT04331665 | 12 Years and older, require supplemental oxygen | A single arm open-label clinical study | Ruxolitinib | ||
| NCT04337359 | 6–90 years, severe/critically ill patients | A single arm open-label, intermediate-size population | Ruxolitinib | ||
| NCT04338958 | Adult, severe/critically ill patients | A single arm, non-randomized open phase II trial | Ruxolitinib | ||
| NCT04348071 | Adult (18–89 years), requires supportive care | An adaptive phase 2/3 clinical trial | Ruxolitinib vs. Standard medical care |
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| NCT04332042 | Adult (18–65 years), hospital admission from less than 24 h | A prospective, single cohort, open study | Tofacitinib | JAK1/JAK3 inhibitor | |
| NCT04322682 | 40 Years and older, possess at least one high-risk criteria | A randomized, double-blind, placebo-controlled, multi-center study | Colchicine vs. Placebo oral tablet |
Inhibition of pyrin and NLRP3 inflammasome activation | Diarrhea; pancytopenia nausea; abdominal pain etc. |
| NCT04322565 | Adult (18–100 years), severe patients | A prospective, phase II, randomized, open-label, Parallel Group Study | Colchicine vs. Standard of care |
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| NCT04328480 | Adult, severe/critically ill patients | A simple pragmatic randomized open controlled trial | Colchicine vs. Local standard of care |
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| NCT04326790 (71) | Adult, severe/critically ill patients | An open label, randomized, parallel group study | Colchicine vs. Standard of care |
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| NCT04350320 | Adult, admitted in the hospital in the previous 48 hours, with clinical status 3, 4, or 5 of WHO classification. | A phase III, prospective, pragmatic, randomized, controlled and open-label trial | Colchicine vs. Standard of care |
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| ChiCTR2000029386 | Adult, severe/critically ill patients | A prospective, phase II, randomized, open-label, Parallel Group Study | Methylprednisolone vs. Standard of care |
Promote the inhibition of HAT and recruitment of HDAC2 activity to downregulate inflammatory genes | Serious Infections: pneumonia, herpes zoster, urinary tract infection; fever; allergy; thrombosis; abnormal blood glucose and pressure; arrhythmia etc. |
| ChiCTR2000029656 | Adult, severe/critically ill patients | A randomized, open-label study | Methylprednisolone vs. Standard of care |
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| NCT04263402 | Adult, severe/critically ill patients | An open, prospective/retrospective, randomized controlled Cohort Study | Methylprednisolone vs. Standard of care |
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| ChiCTR2000030503 | Adult, severe/critically ill patients in ICU | A prospective cohort stud | Blood purification therapy | Remove elevated inflammatory mediators and cytokines | Allergies; fever, thrombosis; hypotension; thrombocytosis; bleeding; air embolism etc. |
| ChiCTR2000029606 | Adult, critically ill patients | An open, randomized controlled trial | Menstrual Blood-derived Stem Cells | Inhibit abnormal activation of T cells and macrophages and induce their differentiation into regulatory T cells and anti-inflammatory macrophages; obstruct the secretion of pro-inflammatory cytokines. | Allergies; fever; arrhythmia etc. |
| ChiCTR2000031139 | Adult (18–80 years), severe/critically ill patients | An open label, single arm study | Embryonic MSCs | ||
| ChiCTR2000030088 | Adult (18–80 years), severe/critically ill patients | An open label, randomized, parallel group study | Wharton’s Jelly MSCs | ||
| NCT04269525 | Adult (18–80 years), severe/critically ill patients | An open label, single arm study | Umbilical cord-derived MSCs | ||
| NCT04252118 | Adult (18–70 years), severe/critically ill patients | An open label, non-randomized, parallel group study | MSCs vs. Standard of care |
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| NCT04288102 | Adult (18–75 years), severe/critically ill patients | A phase II, multicenter, randomized, double-blind, placebo-controlled Trial | MSCs vs. Standard of care |
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| NCT04276987 | Adult (18–75 years), severe/critically ill patients | An open label, single arm, pilot clinical study | Allogenic adipose MSCs | ||
| NCT04273646 | Adult (18–65 years), severe/critically ill patients | An open label, randomized, parallel group study | Umbilical cord-derived MSCs vs. Standard of care |