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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.