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. 2023 Mar 17;14:1100461. doi: 10.3389/fimmu.2023.1100461

Table 7.

Overview of clinical therapeutics for clinical trials in ARDS/ALI.

Target Interventions Indications Primary endpoint Participants Status References
C1/MBL RLS-0071 COVID-19-induced severe ARDS Frequency and severity of Adverse Events, including Serious Adverse Events, by treatment group and dose level, including the frequency of premature discontinuation of study intervention due to Adverse Events 42 Not yet recruiting NCT04574869 (P1)
C3 AMY-101 COVID-19-induced severe ARDS 1) The proportion of patients who are alive, without evidence of ARDS; and 2) The proportion of patients assigned to each category, of a six-category ordinal scale. 144 Not yet recruiting NCT04395456 (P1-P2)
C3 APL-9 COVID-19-induced severe ARDS Cumulative incidence of treatment emergent serious adverse events and treatment-emergent adverse events 66 Recruiting NCT04402060 (P2)
C5 Ravulizumab COVID-19-induced severe ARDS/ALI/pneumonia Survival (based on all-cause mortality) at Day 29 270 Active, not recruiting NCT04369469 (P3)
C5 Zilucoplan® COVID-19-induced severe ARDS 1) Mean change in oxygenation [Time Frame: at predose, day 6 and day 15 (or at discharge, whichever comes first)] defined by Pa02/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio; and 2) Median change in oxygenation [Time Frame: at predose, day 6 and day 15 (or at discharge, whichever comes first)] defined by PaO2/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio 81 Completed NCT04382755 (P2)
C5 SOLIRIS® COVID-19-induced severe ARDS/ALI/pneumonia N/A No longer available NCT04355494 (P2)
C5 SOLIRIS® COVID-19 Mortality N/A Available NCT04288713

ALI, acute lung injury; ARDS, acute respiratory distress syndrome; MBL, mannan-biding lectin; N/A, not available.