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-ES
- Lead Sponsor
- ovartis Farmacéutica S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
• 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) <300 millimeter of mercury (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
• 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
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;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 Outcome Measures
Name Time Method Secondary end point(s): • 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;Timepoint(s) of evaluation of this end point: Up to day 29 after first dose