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Trial record 5 of 1188 for:    "Acute Lung Injury"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04526912
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Viela Bio

Tracking Information
First Submitted Date  ICMJE August 21, 2020
First Posted Date  ICMJE August 26, 2020
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE August 28, 2020
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
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 ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2020)
  • Number and proportion of participants who avoid endotracheal intubation and mechanical ventilation [ Time Frame: Day 1 (Baseline) through Day 28 ]
    Defined as measure of respiratory failure
  • Number and proportion of participants who avoid oxygen delivered by high-flow nasal cannula [ Time Frame: Day 1 (Baseline) through Day 28 ]
    Defined as measure of respiratory failure
  • Number and proportion of participants who avoid non-invasive positive pressure ventilation [ Time Frame: Day 1 (Baseline) through Day 28 ]
    Defined as measure of respiratory failure
  • Number and proportion of participants who avoid extracorporeal membrane oxygenation [ Time Frame: Day 1 (Baseline) through Day 28 ]
    Defined as measure of respiratory failure
  • Number and proportion of participants who avoid shock [ Time Frame: Day 1 (Baseline) through Day 28 ]
    Defined as systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg, or requiring vasopressors
  • Number and proportion of subjects who avoid a clinical diagnosis of respiratory failure [ Time Frame: Day 1 (Baseline) through Day 28 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2020)
  • 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 ]
    Defined as measure of safety
  • Change in safety laboratory parameters [ Time Frame: 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Lung Injury
Intervention  ICMJE
  • Drug: VIB7734
    Single subcutaneous dose
  • Drug: Placebo
    Intravenous single dose matched to VIB7734.
Study Arms  ICMJE
  • Experimental: VIB7734 Dose
    Participants will receive a single subcutaneous dose of VIB7734.
    Intervention: Drug: VIB7734
  • Placebo Comparator: Placebo
    Participants will receive a single subcutaneous dose of placebo (saline) matched to single dose of VIB7734.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2020)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gábor Illei, MD, PhD, MHS 240-920-0072 IlleiG@VielaBio.com
Contact: Daniel Falleroni 240-356-4437 FalleroniD@VielaBio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04526912
Other Study ID Numbers  ICMJE VIB7734.P1.S2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Viela Bio
Study Sponsor  ICMJE Viela Bio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gábor Illei, MD, PhD, MHS Vice President, Clinical Development Lead
PRS Account Viela Bio
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP