Phase 2, randomized, controlled, open label multi-center study to assess efficacy and safety of DFV890 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory functio

Phase 2

Completed

• Conditions: COVID-19 pneumonia; 10038716

• Registration Number: NL-OMON49323
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

* Clinically diagnosed with the SARS-CoV-2 virus
* Hospitalized with COVID-19-induced pneumonia evidenced by chest Xray, CT
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)
* APACHE II score of *10 at time of randomization
* C-reactive protein (CRP) *20 mg/L and/or ferritin level *600 *g/L
* Body weight mass index of *18 to <40kg/m2

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
* 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. In patients in the
Netherlands only, the use of hydroxychloroquine and/or chloroquine in the past
2 weeks are exclusionary
*ALT or AST >5 x ULN (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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>APACHE II severity of disease score on Day 15 or on day of discharge (whichever<br /><br>is earlier) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Serum C-reactive protein (CRP) levels</p><br>