Study to assess efficacy and safety of DFV890 in patients with COVID-19 pneumonia and impaired respiratory functio

Phase 1

• Conditions: COVID-19 pneumonia and impaired respiratory function; MedDRA version: 20.0Level: LLTClassification code 10061986Term: SARSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001870-32-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-29
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•Male and female patients aged 18-80 years inclusive at screening
• Clinically diagnosed with the SARS-CoV-2 virus
• Hospitalized with COVID-19-induced pneumonia evidenced by chest Xray, computed tomography scan (CT scan) or magnetic resonance scan (MR scan), taken within 5 days prior to randomization (within 24 hours
for 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 time of randomization
• C-reactive protein (CRP) =20 mg/L and/or ferritin level =600 µg/L
• Body weight mass index of =18 to <40kg/m2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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
• 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 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
• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified