Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
- Registration Number
- NCT04526912
- Lead Sponsor
- Viela Bio
- Brief Summary
The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Subjects will be administered a single dose of VIB7734 injected under the skin, assessed for efficacy for 28 days and followed for an additional 42 days.
- Detailed Description
This is a randomized, double-blind, placebo-controlled study intended to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Efficacy will be assessed during the 28 days following a single administration of VIB7734. Safety will be assessed for 10 weeks following dosing. The pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of VIB7734 in patients with confirmed SARS-CoV-2 infections will also be assessed.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
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Hospitalized with coronavirus disease 2019 (COVID-19) pneumonia confirmed by World Health Organization criteria.
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Oxygen saturation ≤ 94% at room air or arterial partial pressure of oxygen/fraction of inspired oxygen < 300 mm Hg and > 200 mm Hg.
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Negative influenza test.
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Lymphocyte counts < 10^3/μL and the presence of at least one of the following markers of hyperinflammation within 1 day prior to VIB7734 administration:
- Elevated high sensitivity C-reactive protein (hsCRP) > 50 mg/L
- Ferritin > 500 ng/mL
- Lactate dehydrogenase (LDH) > 300 U/L
- D-dimers > 500 ng/mL
NOTE: Other protocol defined inclusion criteria apply
Key
- Respiratory failure requiring mechanical ventilation.
- In the opinion of the Investigator, progression to mechanical ventilation or death is imminent and inevitable within the next 24 hours.
- Valid Do Not Intubate (DNI) or Do Not Resuscitate (DNR) order.
- Anticipated duration of hospital stay < 72 hours.
- History of allergy or hypersensitivity reaction to any component of the IP.
- Participation in another clinical study with an IP within 4 weeks prior to Day 1 or within 5 half-lives of the IP, whichever is longer. (Participation in COVID-19 antiviral or antimalarial trials may be permitted after discussion with the Medical Monitor).
- Liver cirrhosis or liver failure.
- Known human immunodeficiency virus infection.
- Known hepatitis B or known hepatitis C infection in the absence of a history of curative therapy.
- Known or suspect active or latent tuberculosis infection.
- Active bacterial, fungal, viral, or other infection (besides COVID-19).
- Clinically significant cardiac disease within 6 months.
- History of severely impaired respiratory function at baseline (not related to COVID-19) based on requirement for home oxygen of > 4 L/min or based on other medical history known to the Investigator.
- History of cancer within 12 months of enrollment.
- Receipt of chemotherapy, biologic immunomodulators (including JAK inhibitors), or immunosuppressive therapies within 8 weeks of enrollment, or receipt of rituximab or other B cell-depleting mAb therapy within 6 months.
NOTE: Other protocol defined exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VIB7734 Dose VIB7734 Participants will receive a single subcutaneous dose of VIB7734. Placebo Placebo Participants will receive a single subcutaneous dose of placebo (saline) matched to single dose of VIB7734.
- Primary Outcome Measures
Name Time Method The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness Day 1 (Baseline) through Day 28 Critical illness is defined by respiratory failure (requiring any of the following: endotracheal intubation, oxygen delivered by high flow nasal cannula, non-invasive positive pressure ventilation, extracorporeal membrane oxygenation or clinical diagnosis of respiratory failure) or shock (systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg, or requiring vasopressors)
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events Day 1 (Baseline) through Day 70 Defined as measure of safety
Change in safety laboratory parameters Day 1 (Baseline) through Day 70 Safety evaluation via review of labs (white blood cell (WBC) with differential counts, hemoglobin, platelet count, liver function tests (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], and total bilirubin levels), serum chemistry, cardiac troponin coagulation markers (prothrombin time \[PT\], partial thromboplastin time \[PTT\], D dimer, fibrinogen), and urinalysis)
Trial Locations
- Locations (1)
Research Site
🇺🇸Cleveland, Ohio, United States