Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia

Phase 2, Randomized, Controlled, Open Label Multi-center Study to Assess Efficacy and Safety of DFV890 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infected Patients With Coronavirus Disease 2019 (COVID-19) Pneumonia and Impaired Respiratory Function

ClinicalTrials.gov Identifier: NCT04382053

Novartis Reference Number: CDFV890D12201

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The study will assess the efficacy and safety of DFV890 for the treatment of SARS-Cov-2 infected patients with COVID-19 pneumonia and impaired respiratory function.

Condition 
COVID 19 Pneumonia, Impaired Respiratory Function
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
120 participants
Start date 
May 27, 2020
Completion date 
Dec 21, 2020
Gender 
All
Age(s)
18 Years - 80 Years (Adult, Older Adult)

Interventions

Drug
DFV890
DFV890 administerated in addition to the SoC for 14 days
Drug
Standard of Care (SoC)
SoC includes a variety of supportive therapies that ranges from the administration of supplementary oxygen to full intensive care support, alongside the use of antiviral agents and intravenous corticosteroids.

Eligibility Criteria

Inclusion Criteria

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 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 (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

Study Locations

Argentina
Novartis Investigative Site
Recruiting
Caba, C1180AAX
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, B1846BMF
-
Argentina
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90020-090
RS
Brazil
Novartis Investigative Site
Recruiting
Santo Andre, 09090-790
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Jose do Rio Preto, 15090 000
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 01327 001
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 04029-000
SP
Brazil
Denmark
Novartis Investigative Site
Recruiting
Copenhagen, DK-2400
-
Denmark
Novartis Investigative Site
Recruiting
Hvidovre, 2650
-
Denmark
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69126
Baden-Württemberg
Germany
Novartis Investigative Site
Recruiting
Regensburg, 93053
Bavaria
Germany
Novartis Investigative Site
Recruiting
Bonn, 53105
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30625
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1121
-
Hungary
Novartis Investigative Site
Recruiting
Budapest, H-1097
-
Hungary
India
Novartis Investigative Site
Recruiting
Surat, 395002
Gujrat
India
Novartis Investigative Site
Recruiting
New Delhi, 110029
-
India
Novartis Investigative Site
Recruiting
New Delhi, 110075
-
India
Mexico
Novartis Investigative Site
Recruiting
Ciudad de Mexico, 14080
Mexico CP
Mexico
Netherlands
Novartis Investigative Site
Recruiting
Harderwijk, 3840 AC
-
Netherlands
Peru
Novartis Investigative Site
Recruiting
San Martin de Porres, 31
Lima
Peru
Russian Federation
Novartis Investigative Site
Recruiting
Barnaul, 656045
-
Russian Federation
Novartis Investigative Site
Recruiting
Chelyabinsk, 454021
-
Russian Federation
Novartis Investigative Site
Recruiting
Ekaterinburg, 620035
-
Russian Federation
Novartis Investigative Site
Recruiting
Krasnoyarsk, 660049
-
Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg, 193079
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 199106
-
Russian Federation
South Africa
Novartis Investigative Site
Recruiting
George, 6529
Western Cape
South Africa
Novartis Investigative Site
Recruiting
Cape Town, 7531
-
South Africa
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28006
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]