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.
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.
Drug: VIB7734
Single subcutaneous dose
Drug: Placebo
Intravenous single dose matched to VIB7734.
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
Research Site
Cleveland, Ohio, United States
Gábor Illei, MD, PhD, MHS, Study Director
Vice President, Clinical Development Lead