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

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

ClinicalTrials.gov Identifier: NCT04382651

Novartis Reference Number: CMAS825F12201

Last Update: Dec 16, 2020

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 
COVID-19 Pneumonia, Impaired Respiratory Function
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
140 participants
Start date 
Jun 07, 2020
Completion date 
Apr 14, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
MAS825
Single dose of MAS825 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)

Eligibility Criteria

Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following 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) <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 Criteria:

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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Chula Vista, 91911
California
United States
Novartis Investigative Site
Recruiting
Glendale, 91206
California
United States
Novartis Investigative Site
Recruiting
Irvine, 92697
California
United States
Novartis Investigative Site
Recruiting
La Mesa, 91942
California
United States
Novartis Investigative Site
Recruiting
Mission Hills, 91345
California
United States
Novartis Investigative Site
Recruiting
Santa Monica, 90404
California
United States
Novartis Investigative Site
Recruiting
Torrance, 90503
California
United States
Novartis Investigative Site
Recruiting
Denver, 80220
Colorado
United States
Novartis Investigative Site
Recruiting
Washington, 20037
District of Columbia
United States
Novartis Investigative Site
Recruiting
Idaho Falls, 83404
Idaho
United States
Novartis Investigative Site
Recruiting
Alexandria, 71301
Louisiana
United States
Novartis Investigative Site
Recruiting
Baton Rouge, 70809
Louisiana
United States
Novartis Investigative Site
Recruiting
Lafayette, 70596
Louisiana
United States
Novartis Investigative Site
Recruiting
Boston, 02115
Massachusetts
United States
Novartis Investigative Site
Recruiting
Boston, 02118
Massachusetts
United States
Novartis Investigative Site
Recruiting
Boston, 02215
Massachusetts
United States
Novartis Investigative Site
Recruiting
Brooklyn, 11219
New York
United States
Novartis Investigative Site
Recruiting
Asheville, 28805
North Carolina
United States
Novartis Investigative Site
Recruiting
Columbus, 43214
Ohio
United States
Novartis Investigative Site
Recruiting
Bend, 97701
Oregon
United States
Novartis Investigative Site
Recruiting
Philadelphia, 19140
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Houston, 77030
Texas
United States
Novartis Investigative Site
Active, not recruiting
Mesquite, 75149
Texas
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]