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

NCT ID: NCT04526912

Last Updated: 2021-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-28
• Study Completion Date: 2021-05-19

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.

Conditions

Acute Lung Injury

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VIB7734 Dose

Participants will receive a single subcutaneous dose of VIB7734.

Group Type: EXPERIMENTAL

VIB7734

Intervention Type: DRUG

Single subcutaneous dose

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous single dose matched to VIB7734.

Interventions

VIB7734

Single subcutaneous dose

Intervention Type: DRUG

Placebo

Intravenous single dose matched to VIB7734.

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Viela Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gábor Illei, MD, PhD, MHS

Role: STUDY_DIRECTOR

Vice President, Clinical Development Lead

Locations

Research Site

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

VIB7734.P1.S2

Identifier Type: -

Identifier Source: org_study_id