COVID-19 pneumonia and impaired respiratory function MedDRA version: 20.0 Level: LLT Classification code 10061986 Term: SARS System Organ Class: 100000004862
Conditions
Interventions
Product Name: DFV890
Product Code: DFV890
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet established
Current Sponsor code: DFV890
Other descriptive name: IFM-2427
Concentration unit: mg mill
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Clinically diagnosed with the SARS-CoV-2 virus • Hospitalized with COVID-19-induced pneumonia • Impaired respiratory function, defined as peripheral oxygen saturation (SpO2) =93% on room air or partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • 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 • Have received either oral anti-rejection, or immunomodulatory drugs within the past 2 weeks, or immunomodulatory therapeutic antibodies within the 5 half-lives or 30 days from randomization (whichever is longer), with the exception of hydroxychloroquine, chloroquine or corticosteroids at doses up to and including prednisolone 10mg daily or equivalent • Treatment with a prohibited drug within 5 half-lives or 30 days (whichever is longer) of randomization or during the course of the study •Serum alanine transaminase (ALT) or aspartate transaminase (AST) >5 times upper limit of normal detected within 24 hours at screening or at baseline or other evidence of severe hepatic impairment (Child-Pugh Class C) • Absolute peripheral blood neutrophil count of =1000/mm3 • Estimated glomerular filtration rate (eGFR) =30 mL/min/1.73m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effect of DFV890 in addition to SoC, compared with SoC alone on the Acute Physiology and Chronic Health Evaluation II (APACHE II) score;Secondary Objective: • To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on inflammatory status • To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on clinical status • To evaluate the safety of DFV890 in addition to SoC, compared with SoC alone ;Primary end point(s): Evaluate the effect of DFV890 in addition to SoC, compared with SoC alone on the Acute Physiology and Chronic Health Evaluation II (APACHE II) score;Timepoint(s) of evaluation of this end point: Day 15 or on day of discharge (whichever is earlier) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on inflammatory status •To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on clinical status •To evaluate the safety of DFV890 in addition to SoC, compared with SoC alone ;Timepoint(s) of evaluation of this end point: Up to day 29 after first dose | — |
Countries
Denmark, Germany, Hungary, Netherlands, Spain
Contacts
Public ContactPublic Information Desk
Novartis Hungary Kft.
Outcome results
None listed