Status:
COMPLETED
Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
COVID-19 Pneumonia, Impaired Respiratory Function
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This clinical study was designed to assess the efficacy and safety of DFV890 for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) infected patients with coronavirus diseas...
Detailed Description
This was a Phase II, randomized, controlled, open label multi-center study to assess the efficacy and safety of DFV890 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and imp...
Eligibility Criteria
Inclusion
- Male and female patients aged 18-80 years inclusive at screening.
- 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.
- 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).
- 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 screening.
- C-reactive protein (CRP) ≥20 mg/L and/or ferritin level ≥600 μg/L at screening.
- Body mass index of ≥18 to \<40kg/m2 at screening.
Exclusion
- 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 (according to local laboratory reference ranges) or other evidence if severe hepatic impairment (Child-Pugh Class C).
- Absolute peripheral blood neutrophil count of ≤1000/mm3.
- Estimated GFR (eGFR) ≤30 mL/min/1.73m2 (based on CKD-EPI formula).
- 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.
Key Trial Info
Start Date :
May 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2020
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT04382053
Start Date
May 27 2020
End Date
December 24 2020
Last Update
July 26 2022
Active Locations (29)
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1
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1180AAX
2
Novartis Investigative Site
Buenos Aires, Argentina, B1846BMF
3
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
4
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 04029-000