Study to assess efficacy and safety of DFV890 in patients with COVID-19 pneumonia and impaired respiratory functio
- Conditions
- COVID-19 pneumonia and impaired respiratory functionMedDRA version: 20.0Level: LLTClassification code 10061986Term: SARSSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-001870-32-DK
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
•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
• 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
• 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
- Primary Outcome Measures
Name Time Method 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<br>• To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on clinical status <br>• To evaluate the safety of DFV890 in addition to SoC, compared with SoC alone <br><br>;Primary end point(s): APACHE II severity of disease score;Timepoint(s) of evaluation of this end point: Day 15 or on day of discharge (whichever is earlier)
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Up to day 29 after first dose;Secondary end point(s): • Serum C-reactive protein (CRP) levels<br>• Clinical status over time<br>• Proportion of participants not requiring mechanical ventilation for<br>survival.<br>• Proportion of participants with at least one-point improvement from<br>baseline in clinical status<br>• Number of participants with Adverse Events (AE), Serious Adverse<br>Events (SAE), clinically significant changes in laboratory measures, and<br>vital signs<br><br>