Phase 2
N=143
Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia
COVID-19 Pneumonia, Impaired Respiratory Function
Bottom Line
View on ClinicalTrials.gov: NCT04382053 ↗Enrolled (actual)
143
Serious AEs
19.0%
Results posted
Nov 2021
Primary outcome: Primary: APACHE II Severity of Disease Score on Day 15 or on the Day of Discharge (Whichever is Earlier) — 8.7; 8.6 Score on a scale — p=0.467
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DFV890 (Drug); Standard of Care (SoC) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY APACHE II Severity of Disease Score on Day 15 or on the Day of Discharge (Whichever is Earlier) |
8.7; 8.6 | 0.467 |
| SECONDARY Serum C-reactive Protein (CRP) Levels |
31.4; 46.6; 22.2; 26.5; 11.5; 15.1 | 0.237 |
| SECONDARY Clinical Status Over Time |
4.3; 4.3; 4.3; 4.3; 4.3; 4.3 | — |
| SECONDARY Number of Participants Not Requiring Mechanical Ventilation for Survival |
60; 59; 60; 58 | — |
| SECONDARY Number of Participants With at Least One-point Improvement From Baseline in Clinical Status |
59; 53; 61; 60 | — |
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 disease 2019 (COVID-19) pneumonia and impaired respiratory function.
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) 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.
Data sourced from ClinicalTrials.gov (NCT04382053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.