- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04526912
Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection (ALI)
December 16, 2021 updated by: Viela Bio
A Proof of Concept Study of the Safety and Efficacy of VIB7734 for the Treatment and Prevention of Acute Lung Injury (ALI) in Patients With SARS-CoV-2 Infection
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44195
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Hospitalized with coronavirus disease 2019 (COVID-19) pneumonia confirmed by World Health Organization criteria.
- Oxygen saturation ≤ 94% at room air or arterial partial pressure of oxygen/fraction of inspired oxygen < 300 mm Hg and > 200 mm Hg.
- Negative influenza test.
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 Exclusion Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VIB7734 Dose
Participants will receive a single subcutaneous dose of VIB7734.
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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.
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Intravenous single dose matched to VIB7734.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness
Time Frame: Day 1 (Baseline) through Day 28
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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)
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Day 1 (Baseline) through Day 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events
Time Frame: Day 1 (Baseline) through Day 70
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Defined as measure of safety
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Day 1 (Baseline) through Day 70
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Change in safety laboratory parameters
Time Frame: Day 1 (Baseline) through Day 70
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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)
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Day 1 (Baseline) through Day 70
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gábor Illei, MD, PhD, MHS, Vice President, Clinical Development Lead
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2020
Primary Completion (Actual)
April 8, 2021
Study Completion (Actual)
May 19, 2021
Study Registration Dates
First Submitted
August 21, 2020
First Submitted That Met QC Criteria
August 21, 2020
First Posted (Actual)
August 26, 2020
Study Record Updates
Last Update Posted (Actual)
December 17, 2021
Last Update Submitted That Met QC Criteria
December 16, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIB7734.P1.S2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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