Study of Efficacy and Safety of MAS825 in Patients With COVID-19

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19 Pneumonia, Impaired Respiratory Function

In brief

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.

Key facts

Study ID

NCT04382651

Run by

Novartis Pharmaceuticals

People needed

140

Starts

2020-06-11

Expected to finish

2021-04-21

Last updated by the study team

2022-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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) <300 millimeter of mercury (mmHg) at time of screening For cities located at altitudes greater than 2500 m above sea level, these will be substituted with SpO2 <90% and PaO2/FiO2 <250 mmHg
• Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II score of ≥10 at time of screening
• CRP ≥20 mg/L or ferritin level ≥600 μg/L at screening
• Body weight between 45 kg and 145 kg, inclusive, at screening
• Ability to comply with the study protocol, in the investigator's judgment

You may not qualify if…

• History of hypersensitivity to the investigational treatment or their excipients or to drugs of similar chemical classes
• Suspected active or chronic bacterial (including Mycobacterium tuberculosis), fungal, viral, or other infection with the exception of SARS-CoV-2
• In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
• Intubated prior to randomization
• Patients who have explicitly expressed the wish not to receive intensive care support when this would be indicated based on their condition
• Previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of anti-viral therapies or corticosteroids
• For COVID-19 infection, ongoing corticosteroid treatment is permitted at doses as per local SoC
• For non-COVID-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent.
• Serum alanine transaminase (ALT) or aspartate transaminase (AST) >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.

Where it is running

• Novartis Investigative Site — Chula Vista, California, United States
• Novartis Investigative Site — Glendale, California, United States
• Novartis Investigative Site — Irvine, California, United States
• Novartis Investigative Site — La Mesa, California, United States
• Novartis Investigative Site — Santa Monica, California, United States
• Novartis Investigative Site — Torrance, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Washington D.C., District of Columbia, United States
• Novartis Investigative Site — Idaho Falls, Idaho, United States
• Novartis Investigative Site — Alexandria, Louisiana, United States
• Novartis Investigative Site — Baton Rouge, Louisiana, United States
• Novartis Investigative Site — Lafayette, Louisiana, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Brooklyn, New York, United States
• Novartis Investigative Site — Asheville, North Carolina, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Bend, Oregon, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Mesquite, Texas, United States

Full record on ClinicalTrials.gov

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