18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in OxygenationPrimary· 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
change from baseline in PaO2/FiO2 day 6
Group
Value
95% CI
Group A (Active)
56.4
31.9 – 80.9
Group B (Control)
20.6
17.3 – 58.5
change from baseline in PaO2/FiO2 day 15
Group
Value
95% CI
Group A (Active)
123.5
94.3 – 152.7
Group B (Control)
83.7
39.0 – 128.4
change from baseline in a/A PO2 day 6
Group
Value
95% CI
Group A (Active)
0.10
0.06 – 0.15
Group B (Control)
0.04
0.04 – 0.11
change from baseline in a/A PO2 day 15
Group
Value
95% CI
Group A (Active)
0.25
0.19 – 0.31
Group B (Control)
0.17
0.08 – 0.26
Change in OxygenationPrimary· 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
(A-a) gradient day 6
Group
Value
95% CI
Group A (Active)
114.6
92.6 – 141.9
Group B (Control)
146.7
105.4 – 204.3
(A-a) gradient day 15
Group
Value
95% CI
Group A (Active)
58.6
44.9 – 76.5
Group B (Control)
86.9
57.9 – 130.6
Mean Change in 6-point Ordinal Scale Change for Clinical ImprovementSecondary· between day 1 and respectively day 6, day 15 (or discharge, whichever comes first) and day 28 (by phone call).
6-point ordinal scale defined as
1. Death
2. Hospitalized, on invasive mechanical ventilation or ECMO;
3. Hospitalized, on non-invasive ventilation
4. Hospitalized, requiring supplemental oxygen
5. Hospitalized, not requiring supplemental oxygen
6. Not hospitalized
mean change in 6-point ordinal scale change day 6
Group
Value
95% CI
Group A (Active)
0.1
± 1.0
Group B (Control)
0.1
± 0.9
mean change in 6-point ordinal scale change day 15
Group
Value
95% CI
Group A (Active)
1.2
± 1.4
Group B (Control)
1
± 1.5
mean change in 6-point ordinal scale change day 28
Group
Value
95% CI
Group A (Active)
1.7
± 1.5
Group B (Control)
1.3
± 1.8
Number of Days With HypoxiaSecondary· during hospital admission (up to 28 days)
defined as SpO2 \< 93% breathing room air or the dependence on supplemental oxygen
Group
Value
95% CI
Group A (Active)
13
3 – 28
Group B (Control)
10
2 – 28
Number of Days of Supplemental Oxygen UseSecondary· during hospital admission (up to 28 days)
Group
Value
95% CI
Group A (Active)
13
3 – 28
Group B (Control)
10
2 – 28
Time to Absence of Fever (Defined as 37.1°C or More) for More Than 48h Without AntipyreticSecondary· during hospital admission (up to 28 days)
Group
Value
95% CI
Group A (Active)
7
1 – 28
Group B (Control)
3
1 – 28
Number of Days With FeverSecondary· during hospital admission (up to 28 days)
defined as 37.1°C or more
Group
Value
95% CI
Group A (Active)
7
0 – 28
Group B (Control)
4
0 – 20
Mean Change in CRP Levels Between Day 1 and Day 6Secondary· day 1, day 6
Group
Value
95% CI
Group A (Active)
-89.6
± 91.5
Group B (Control)
-100
± 61.9
Mean Change in CRP Levels Between Day 1 and Day 15 (or Discharge Whichever Comes First)Secondary· day 1, day 15
Group
Value
95% CI
Group A (Active)
-91.0
± 106.3
Group B (Control)
-96.2
± 98.4
Mean Change in Ferritin Levels Between Day 1 and Day 6Secondary· day 1, day 6
Group
Value
95% CI
Group A (Active)
-544.4
± 1489.9
Group B (Control)
-282.3
± 517.0
Mean Change in Ferritin Levels Between Day 1 and Day 15 (or Discharge, Whichever Comes First)Secondary· day 1, day 15
Group
Value
95% CI
Group A (Active)
-201.0
± 6204.5
Group B (Control)
-303.9
± 948.4
Number of Participants With Adverse EventsSecondary· during hospital admission (up to 28 days)
Any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Group
Value
95% CI
Group A (Active)
39
Group B (Control)
17
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality monitored for up to 22 weeks, serious adverse events monitored for up to 20 weeks and other adverse events monitored for up to 28 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study is a randomized controlled, open-label trial comparing subcutaneous Zilucoplan® with standard of care to standard of care alone.
In the active group, Zilucoplan® will be administered subcutaneously once daily for 14 days or till discharge from the hospital, whichever comes first.
The hypothesis of the proposed intervention is that Zilucoplan® (complement C5 inhibitor) has profound effects on inhibiting acute lung injury post COVID-19, and can promote lung repair mechanisms, that lead to a 25% improvement in lung oxygenation parameters. This hypothesis is based on experiments performed in mice showing that C5a blockade can prevent mortality and prevent ARDS in mice with post-viral acute lung injury.
Eligible patients include patients with confirmed COVID-19 infection suffering from hypoxic respiratory failure defined as O2 saturation below 93% on minimal 2l/min O2 therapy and/or ratio PaO2/FiO2 below 350.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Ghent
Last refreshed: 14 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04382755.