Status:
COMPLETED
Study of Efficacy and Safety of MAS825 in Patients With COVID-19
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
COVID-19 Pneumonia, Impaired Respiratory Function
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 diseas...
Detailed Description
This was a Phase 2, randomized, placebo -controlled, participant and investigator blinded, multi-center study to assess efficacy and safety of MAS825 for the treatment of SARS-CoV-2 infected patients ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04382651
Start Date
June 11 2020
End Date
April 21 2021
Last Update
August 10 2022
Active Locations (21)
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1
Novartis Investigative Site
Chula Vista, California, United States, 91911
2
Novartis Investigative Site
Glendale, California, United States, 91206
3
Novartis Investigative Site
Irvine, California, United States, 92697
4
Novartis Investigative Site
La Mesa, California, United States, 91942