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Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection (ALI)

Primary Purpose

Acute Lung Injury

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VIB7734
Placebo
Sponsored by
Viela Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring pneumonia, COVID-19, SARS-Cov-2, acute respiratory disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VIB7734 Dose

Placebo

Arm Description

Participants will receive a single subcutaneous dose of VIB7734.

Participants will receive a single subcutaneous dose of placebo (saline) matched to single dose of VIB7734.

Outcomes

Primary Outcome Measures

The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness
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
Defined as measure of safety
Change in safety laboratory parameters
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)

Full Information

First Posted
August 21, 2020
Last Updated
December 16, 2021
Sponsor
Viela Bio
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1. Study Identification

Unique Protocol Identification Number
NCT04526912
Brief Title
Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
Acronym
ALI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Study met predefined futility criteria for efficacy endpoints.
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
April 8, 2021 (Actual)
Study Completion Date
May 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viela Bio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
pneumonia, COVID-19, SARS-Cov-2, acute respiratory disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VIB7734 Dose
Arm Type
Experimental
Arm Description
Participants will receive a single subcutaneous dose of VIB7734.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single subcutaneous dose of placebo (saline) matched to single dose of VIB7734.
Intervention Type
Drug
Intervention Name(s)
VIB7734
Intervention Description
Single subcutaneous dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous single dose matched to VIB7734.
Primary Outcome Measure Information:
Title
The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness
Description
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)
Time Frame
Day 1 (Baseline) through Day 28
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events
Description
Defined as measure of safety
Time Frame
Day 1 (Baseline) through Day 70
Title
Change in safety laboratory parameters
Description
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)
Time Frame
Day 1 (Baseline) through Day 70

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gábor Illei, MD, PhD, MHS
Organizational Affiliation
Vice President, Clinical Development Lead
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection

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