COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04382053

Novartis pharmaceuticals

novartis.email@novartis.com

2020-05-11

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: male and female patients aged 18-80 years inclusive at screening. 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 (within 24 hours in patients in the netherlands). 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 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. apache ii score of ≥10 at screening. c-reactive protein (crp) ≥20 mg/l and/or ferritin level ≥600 μg/l at screening. body mass index of ≥18 to <40kg/m2 at screening.

suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection (besides 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. 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 hydroxychloroquine, chloroquine 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. in patients in the netherlands only, the use of hydroxychloroquine and/or chloroquine in the past 2 weeks are exclusionary. serum alanine transaminase (alt) or aspartate transaminase (ast) >5 times upper limit of normal detected within 24 hours at screening or at baseline (according to local laboratory reference ranges) or other evidence if severe hepatic impairment (child-pugh class c). absolute peripheral blood neutrophil count of ≤1000/mm3. estimated gfr (egfr) ≤30 ml/min/1.73m2 (based on ckd-epi formula). patients currently being treated with drugs known to be strong or moderate inducers of isoenzyme cyp2c9 and/or strong inhibitors of cyp2c9 and/or strong inducers of cytochrome p450, family 3, subfamily a (cyp3a) and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment. patients with innate or acquired immunodeficiencies. patients who have undergone solid organ or stem cell transplantation.

2

Novartis Pharmaceuticals

18

80

Argentina;Brazil;Denmark;Germany;Hungary;India;Mexico;Netherlands;Peru;Russia;South Africa;Spain

Severe disease at enrollment

6: Severe disease at enrollment

143

APACHE II severity of disease score on Day 15 or on the day of discharge (whichever is earlier)

None

Phase 2

[{"arm_notes": "Results also available for EUCTR2020-001870-32 on https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001870-32/results", "treatment_id": 402, "treatment_name": "Dfv890", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Results also available for EUCTR2020-001870-32 on https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001870-32/results", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]