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

• Status: Terminated
• Trial end date: 2021-05-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Viela Bio

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