Purpose

The study will assess the efficacy and safety of MAS825 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Participants eligible for inclusion in this study must meet all of the following criteria: 1. Male and female patients aged ≥18 years at screening 2. 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) 3. 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 4. 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) 5. 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 6. Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II score of ≥10 at time of screening 7. CRP ≥20 mg/L or ferritin level ≥600 μg/L at screening 8. Body weight between 45 kg and 145 kg, inclusive, at screening 9. Ability to comply with the study protocol, in the investigator's judgment

Exclusion Criteria

  1. History of hypersensitivity to the investigational treatment or their excipients or to drugs of similar chemical classes 2. Suspected active or chronic bacterial (including Mycobacterium tuberculosis), fungal, viral, or other infection with the exception of SARS-CoV-2 3. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment 4. Intubated prior to randomization 5. Patients who have explicitly expressed the wish not to receive intensive care support when this would be indicated based on their condition 6. 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. 7. 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. 8. Absolute peripheral blood neutrophil count of ≤1000/mm^3 9. Estimated GFR (eGFR) ≤30 mL/min/1.73m^2 (based on CKD-EPI formula) 10. Pregnant or breastfeeding, or positive urine or serum pregnancy test in a pre-dose examination 11. 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 12. 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). 13. Current participation in any other investigational trials, with the exception of (not yet) approved COVID-19 therapies that are considered (local) standard of care.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MAS825 + SoC
Single dose of MAS825 by i.v. infusion, in addition to Standard of Care (Soc)
  • Drug: MAS825
    Single dose of MAS825 by i.v. infusion, in addition to Standard of Care (Soc)
Placebo Comparator
Matching placebo + SoC
Single dose of Matching Placebo by i.v. infusion, in addition to Standard of Care (Soc)
  • Drug: Matching placebo
    Single dose of Matching Placebo by i.v. infusion, in addition to Standard of Care (Soc)

Recruiting Locations

Novartis Investigative Site
Chula Vista, California 91911

Novartis Investigative Site
Glendale, California 91206

Novartis Investigative Site
Irvine, California 92697

Novartis Investigative Site
La Mesa, California 91942

Novartis Investigative Site
Mission Hills, California 91345

Novartis Investigative Site
Santa Monica, California 90404

Novartis Investigative Site
Torrance, California 90503

Novartis Investigative Site
Denver, Colorado 80220

Novartis Investigative Site
Washington, District of Columbia 20037

Novartis Investigative Site
Alexandria, Louisiana 71301

Novartis Investigative Site
Baton Rouge, Louisiana 70809

Novartis Investigative Site
Lafayette, Louisiana 70596

Novartis Investigative Site
Boston, Massachusetts 02115

Novartis Investigative Site
Boston, Massachusetts 02118

Novartis Investigative Site
Boston, Massachusetts 02215

Novartis Investigative Site
Brooklyn, New York 11219

Novartis Investigative Site
Asheville, North Carolina 28805

Novartis Investigative Site
Columbus, Ohio 43214

Novartis Investigative Site
Bend, Oregon 97701

Novartis Investigative Site
Philadelphia, Pennsylvania 19140

Novartis Investigative Site
Houston, Texas 77030

Novartis Investigative Site
Mesquite, Texas 75149

More Details

NCT ID
NCT04382651
Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Detailed Description

This is 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 with COVID-19 pneumonia and impaired respiratory function. The study consists of five parts: 1. Screening / Baseline / Treatment (Day -1 to 1): lasts up to a maximum of 24 hours and comprises a screening / baseline assessment. This visit will be used to confirm that the study inclusion and exclusion criteria are met and serves as baseline assessment prior to randomization. Baseline blood tests will be performed in all patients; those who screen fail because of study inclusion / exclusion criteria (e.g., serum CRP, liver function tests), will not undergo randomization. Eligible patients will receive a single i.v. infusion of MAS825 or placebo on Day -1 to 1. 2. Treatment period (Day 2-15): Study assessments to be conducted every 2 days for hospitalized patients. If patients are discharged from the hospital prior to Day 15, assessments on the day of discharge should be performed according to the schedule listed under Day 15 and patient should return to the site for the Day 15 assessment (all other visits between discharge and Day 15 can be omitted). If hospital visit is not possible at Day 15, then home nursing services may be used to support this last visit where these are available in accordance with local guidelines and should include all possible assessments (e.g. oxygen saturation with portable monitors). In case home nursing is not possible, patients will be contacted by phone on day 15. 3. Follow-up (Day 16-29): After completion of the treatment period, patients will be observed until Day 29 or discharged from hospital, whichever is sooner. Study assessments to be conducted every 2 days for domiciled patients. Where patients are discharged from hospital prior to Day 29, a study visit conducted by telephone will occur on Day 29 (all other visits between discharge and Day 29 can be omitted). 4. Safety follow-up visit assessment (Day 45): A follow-up visit will be conducted at Day 45 if the patient is hospitalized. If patients are discharged from hospital prior to Day 45, a study visit will be conducted by telephone on Day 45. 5. End of Study/Safety follow-up visit assessment (Day 127): A follow-up visit for safety will be conducted at Day 127 if the patient is hospitalized. If patients are discharged from hospital prior to Day 127, a study visit will be conducted by telephone on Day 127.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.