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

NCT04526912 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: VIB7734.P1.S2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lung Injury

Keywords

pneumonia; COVID-19; SARS-Cov-2; acute respiratory disease

Outcome Measures

Primary Outcomes (1)

• 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)

  Day 1 (Baseline) through Day 28

Secondary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events

  Day 1 (Baseline) through Day 70

• Change in safety laboratory parameters

  Day 1 (Baseline) through Day 70

Study Arms (2)

VIB7734 Dose

EXPERIMENTAL

Participants will receive a single subcutaneous dose of VIB7734.

Drug: VIB7734

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

VIB7734 DRUG

Single subcutaneous dose

VIB7734 Dose

Placebo DRUG

Intravenous single dose matched to VIB7734.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viela Bio: lead

Study Sites (1)

Research Site

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Acute Lung Injury; Pneumonia; COVID-19

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Gábor Illei, MD, PhD, MHS

  Vice President, Clinical Development Lead

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 26, 2020
• Study Start: August 28, 2020
• Primary Completion: April 8, 2021
• Study Completion: May 19, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)