COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04382651

Novartis Pharmaceuticals

novartis.email@novartis.com

2020-05-11

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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) <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

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.

2

Novartis Pharmaceuticals

18

80

United States

Severe disease at enrollment

6: Severe disease at enrollment

140

APACHE II Severity of Disease Score on Day 15 or on the Day of Discharge (Whichever is Earlier)

None

Phase 2

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