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

Purpose

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

  • Acute Lung Injury

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT04526912
Status
Terminated
Sponsor
Viela Bio

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.