18 and older, any sex, with COVID-19 Pneumonia, Impaired Respiratory Function. 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.
APACHE II Severity of Disease Score on Day 15 or on the Day of Discharge (Whichever is Earlier)Primary· up to Day 15
The APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death. In practice, it is rare for any participant to accumulate more than 55 points.
APACHE II score was measured on Day 15 or on the day of discharge (whichever was earlier). Participants who died on Day 15 or earlier were assigned the highest observed APACHE II score of any of the participants at any time during the trial (worst case im
Group
Value
95% CI
MAS825 + SoC
14.5
± 1.87
Placebo + SoC
13.5
± 1.8
Serum C-reactive Protein (CRP) LevelsSecondary· Baseline, days 2, 4, 6, 8, 10, 12, 14 and 15
C-reactive protein (CRP) is a blood test marker for inflammation in the body. It was analyzed on a log-scale fitting a repeated measures mixed model: treatment, visit, stratification factors, visit \* treatment and visit \* stratification factors as fixed effects and log-transformed baseline score and visit \* log-transformed baseline score as continuous covariate. Values reported were back-transformed to original scale.
Day 2
Group
Value
95% CI
MAS825 + SoC
55.50
± 1.11
Placebo + SoC
57.70
± 1.10
Day 4
Group
Value
95% CI
MAS825 + SoC
28.30
± 1.19
Placebo + SoC
37.10
± 1.19
Day 6
Group
Value
95% CI
MAS825 + SoC
19.80
± 1.24
Placebo + SoC
22.30
± 1.24
Day 8
Group
Value
95% CI
MAS825 + SoC
15.00
± 1.31
Placebo + SoC
16.6
± 1.30
Day 10
Group
Value
95% CI
MAS825 + SoC
10.10
± 1.38
Placebo + SoC
19.80
± 1.35
Day 12
Group
Value
95% CI
MAS825 + SoC
11.00
± 1.42
Placebo + SoC
15.80
± 1.39
Day 14
Group
Value
95% CI
MAS825 + SoC
7.30
± 1.43
Placebo + SoC
13.20
± 1.39
Day 15
Group
Value
95% CI
MAS825 + SoC
5.70
± 1.40
Placebo + SoC
11.60
± 1.36
Ferritin LevelsSecondary· Baseline, days 2, 4, 6, 8, 10, 12, 14 and 15
Ferritin is a blood test marker for inflammation in the body. For a standard ferritin test, a normal reading is less than 300 micrograms per liter (μg/L). It was analyzed on a log-scale fitting a repeated measures mixed model: treatment, visit, stratification factors, visit \* treatment and visit \* stratification factors as fixed effects and log-transformed baseline score and visit \* log-transformed baseline score as continuous covariate. Values reported were back-transformed to original scale.
Day 2
Group
Value
95% CI
MAS825 + SoC
773.20
± 1.05
Placebo + SoC
800.20
± 1.05
Day 4
Group
Value
95% CI
MAS825 + SoC
692.70
± 1.05
Placebo + SoC
701.40
± 1.05
Day 6
Group
Value
95% CI
MAS825 + SoC
687.50
± 1.10
Placebo + SoC
622.10
± 1.10
Day 8
Group
Value
95% CI
MAS825 + SoC
674.00
± 1.12
Placebo + SoC
667.80
± 1.11
Day 10
Group
Value
95% CI
MAS825 + SoC
670.00
± 1.16
Placebo + SoC
776.00
± 1.15
Day 12
Group
Value
95% CI
MAS825 + SoC
680.00
± 1.18
Placebo + SoC
754.50
± 1.17
Day 14
Group
Value
95% CI
MAS825 + SoC
541.70
± 1.22
Placebo + SoC
595.70
± 1.22
Day 15
Group
Value
95% CI
MAS825 + SoC
502.90
± 1.21
Placebo + SoC
504.20
± 1.21
Number of Participants Not Requiring Mechanical Ventilation for SurvivalSecondary· Until Day 15 (Assessments on Days 2, 4, 6, 8, 10, 12, 14 and 15) and until Day 29 (Additional assessments on Days 17, 19, 21, 23, 25, 27 and 29)
Number of participants not requiring mechanical ventilation for survival until Day 15 and Day 29: defined by WHO 9-point ordinal scale score of \< 6 points at all time points assessments.
The scoring is - Uninfected patients have a score 0. - Ambulatory patients can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanica
Until Day 15
Group
Value
95% CI
MAS825 + SoC
41
Placebo + SoC
47
Until Day 29
Group
Value
95% CI
MAS825 + SoC
39
Placebo + SoC
45
Number of Participants With at Least One-point Improvement From Baseline in Clinical StatusSecondary· Baseline, Day 15 and Day 29
Number of participants with at least one-point improvement from baseline in clinical status, which was measured with WHO 9-point ordinal scale.
The scoring is - Uninfected patients have a score 0. - Ambulatory patients can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additiona
Day 15
Group
Value
95% CI
MAS825 + SoC
39
Placebo + SoC
39
Day 29
Group
Value
95% CI
MAS825 + SoC
43
Placebo + SoC
46
Clinical Status Over TimeSecondary· Baseline, days 2, 4, 6, 8, 10, 12, 14, 15, 17, 19, 21, 23, 25, 27, 29, 45 and 127
Clinical status was measured with World Health Organization (WHO) 9-point ordinal scale.
The scoring is - Uninfected patients have a score 0. - Ambulatory patients can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, renal replacement therapy,
Baseline
Group
Value
95% CI
MAS825 + SoC
4.8
± 0.38
Placebo + SoC
4.7
± 0.49
Day 2
Group
Value
95% CI
MAS825 + SoC
4.8
± 0.71
Placebo + SoC
4.7
± 0.57
Day 4
Group
Value
95% CI
MAS825 + SoC
4.8
± 0.90
Placebo + SoC
4.7
± 1.13
Day 6
Group
Value
95% CI
MAS825 + SoC
4.8
± 1.27
Placebo + SoC
4.7
± 1.40
Day 8
Group
Value
95% CI
MAS825 + SoC
4.9
± 1.63
Placebo + SoC
4.5
± 1.64
Day 10
Group
Value
95% CI
MAS825 + SoC
4.9
± 1.76
Placebo + SoC
4.6
± 1.80
Day 12
Group
Value
95% CI
MAS825 + SoC
5.0
± 1.97
Placebo + SoC
4.7
± 2.04
Day 14
Group
Value
95% CI
MAS825 + SoC
5.0
± 2.04
Placebo + SoC
4.8
± 2.09
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from the date of administration of study treatment to day 127..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This clinical study was designed to assess the efficacy and safety of MAS825 for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) infected patients with coronavirus disease 2019 (COVID-19) pneumonia and impaired respiratory function.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07203001 — A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participant
· Phase 2
· recruiting
NCT06097663 — A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in
· Phase 2
· completed
NCT06309823 — A Single-patient Clinical Trial of MAS825 in a Patient With XIAP Deficiency
· Phase 3
· completed
NCT04641442 — Study to Evaluate the Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammato
· Phase 2
· active not recruiting
NCT04665154 — A First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of MAS825 in Healthy Volunteers
· Phase 1
· completed
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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 Novartis Pharmaceuticals
Last refreshed: 10 August 2022
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/NCT04382651.