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

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Status and phase: Terminated; Phase 1

Conditions: Acute Lung Injury

Treatments: Drug: VIB7734; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04526912

VIB7734.P1.S2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

VIB7734 Dose

Experimental group

Description:

Participants will receive a single subcutaneous dose of VIB7734.

Treatment:

Drug: VIB7734

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo