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Trial record 5 of 11 for:    Viela Bio | United States

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

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
Acute Lung Injury Drug: VIB7734 Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: VIB7734 Dose
Participants will receive a single subcutaneous dose of VIB7734.
Drug: VIB7734
Single subcutaneous dose

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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526912


Contacts
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Contact: Gábor Illei, MD, PhD, MHS 240-920-0072 IlleiG@VielaBio.com
Contact: Daniel Falleroni 240-356-4437 FalleroniD@VielaBio.com

Locations
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United States, Ohio
Research Site Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Viela Bio
Investigators
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Study Director: Gábor Illei, MD, PhD, MHS Vice President, Clinical Development Lead
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Responsible Party: Viela Bio
ClinicalTrials.gov Identifier: NCT04526912    
Other Study ID Numbers: VIB7734.P1.S2
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viela Bio:
pneumonia
COVID-19
SARS-Cov-2
acute respiratory disease
Additional relevant MeSH terms:
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Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders