Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: DFV890 and SoC V/s SoC-100mg: Orally-Tablets
Control Intervention1: Standard of Care (SoC): Orally -Tablets
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 2.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) 3. Impaired respiratory function, defined as peripheral oxygen saturation (SpO2) =93% on room air or partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) 4.APACHE II score of =10 at screening 5. C-reactive protein (CRP) =20 mg/L and/or ferritin level =600 µg/L at screening 6. Body mass index of =18 to
Exclusion criteria
Exclusion criteria: 1. Suspected active or chronic bacterial (including Mycobacterium tuberculosis), fungal, viral, or other infection (besides SARS-CoV-2) 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 3. Intubated prior to randomization 4. 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 5.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) 6. Absolute peripheral blood neutrophil count of =1000/mm3 7. Estimated GFR (eGFR) =30 mL/min/1.73m2 (based on CKD-EPI formula) 8. 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 9. Patients with innate or acquired immunodeficiencies 10. Patients who have undergone solid organ or stem cell transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| APACHE II severity of disease score on Day 15 or on the day of dischargeTimepoint: Time Frame: up to Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum C-reactive protein (CRP) levelsTimepoint: Time Frame: up to Day 29;Clinical status over timeTimepoint: Time Frame: up to Day 29;Proportion of participants not requiring mechanical ventilation for survivalTimepoint: Time Frame: Day 15, Day 29;Proportion of participants with at least one-point improvement from baseline in clinical statusTimepoint: Time Frame: Baseline, Day 15, Day 29 | — |
Countries
Argentina, Brazil, Denmark, Germany, Hungary, India, Mexico, Netherlands, Peru, Russian Federation, South Africa, Spain
Contacts
Public ContactMurugananthan K
Novartis Healthcare PVT LTD
Outcome results
None listed