Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: VIB7734 Dose Participants will receive a single subcutaneous dose of VIB7734. |
Drug: VIB7734
Single subcutaneous dose
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Placebo Comparator: Placebo Participants will receive a single subcutaneous dose of placebo (saline) matched to single dose of VIB7734. |
Drug: Placebo
Intravenous single dose matched to VIB7734.
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Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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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:
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Elevated high sensitivity C-reactive protein (hsCRP) > 50 mg/L
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Ferritin > 500 ng/mL
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Lactate dehydrogenase (LDH) > 300 U/L
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D-dimers > 500 ng/mL
NOTE: Other protocol defined inclusion criteria apply
Key Exclusion Criteria:
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Respiratory failure requiring mechanical ventilation.
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In the opinion of the Investigator, progression to mechanical ventilation or death is imminent and inevitable within the next 24 hours.
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Valid Do Not Intubate (DNI) or Do Not Resuscitate (DNR) order.
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Anticipated duration of hospital stay < 72 hours.
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History of allergy or hypersensitivity reaction to any component of the IP.
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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).
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Liver cirrhosis or liver failure.
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Known human immunodeficiency virus infection.
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Known hepatitis B or known hepatitis C infection in the absence of a history of curative therapy.
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Known or suspect active or latent tuberculosis infection.
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Active bacterial, fungal, viral, or other infection (besides COVID-19).
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Clinically significant cardiac disease within 6 months.
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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.
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History of cancer within 12 months of enrollment.
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Research Site | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Viela Bio
Investigators
- Study Director: Gábor Illei, MD, PhD, MHS, Vice President, Clinical Development Lead
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VIB7734.P1.S2