Phase 2
N=140
Study of Efficacy and Safety of MAS825 in Patients With COVID-19
COVID-19 Pneumonia, Impaired Respiratory Function
Bottom Line
View on ClinicalTrials.gov: NCT04382651 ↗Enrolled (actual)
140
Serious AEs
42.8%
Results posted
Apr 2022
Primary outcome: Primary: APACHE II Severity of Disease Score on Day 15 or on the Day of Discharge (Whichever is Earlier) — 14.5; 13.5 Score on a scale — p=0.33
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MAS825 (Drug); Placebo (Other); Standard of Care (SoC) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY APACHE II Severity of Disease Score on Day 15 or on the Day of Discharge (Whichever is Earlier) |
14.5; 13.5 | 0.33 |
| SECONDARY Serum C-reactive Protein (CRP) Levels |
55.50; 57.70; 28.30; 37.10; 19.80; 22.30 | — |
| SECONDARY Ferritin Levels |
773.20; 800.20; 692.70; 701.40; 687.50; 622.10 | — |
| SECONDARY Number of Participants Not Requiring Mechanical Ventilation for Survival |
41; 47; 39; 45 | — |
| SECONDARY Number of Participants With at Least One-point Improvement From Baseline in Clinical Status |
39; 39; 43; 46 | — |
| SECONDARY Clinical Status Over Time |
4.8; 4.7; 4.8; 4.7; 4.8; 4.7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Male and female patients aged ≥18 years at screening
- Signed Informed Consent Form (ICF) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements)
- Clinically diagnosed with the SARS-CoV-2 virus by polymerase chain reaction (PCR) or by other approved diagnostic methodology within 7 days prior to randomization
- Hospitalized with COVID-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (CT scan) or magnetic resonance scan (MR scan) (taken within 5 days prior to randomization)
- Impaired respiratory function, defined as peripheral oxygen saturation (SpO2) ≤93% on room air or partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) 5 times upper limit of normal detected within 24 hours at screening/baseline (according to local laboratory reference ranges) or other evidence of severe hepatic impairment.
- Absolute peripheral blood neutrophil count of ≤1000/mm^3
- Estimated GFR (eGFR) ≤30 mL/min/1.73m^2 (based on CKD-EPI formula)
- Pregnant or breastfeeding, or positive urine or serum pregnancy test in a pre-dose examination
- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to abstain from any sexual intercourse for a total of 29 days after randomization (the 14-day treatment period plus a 14-day follow-up period).
- Current participation in any other investigational trials, with the exception of (not yet) approved COVID-19 therapies that are considered (local) standard of care.
Data sourced from ClinicalTrials.gov (NCT04382651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.