Clinical trial NCT04526912: Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
Official title: A Proof of Concept Study of the Safety and Efficacy of VIB7734 for the Treatment and Prevention of Acute Lung Injury (ALI) in Patients With SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Lung Injury
Keywords: pneumonia
COVID-19
SARS-Cov-2
acute respiratory disease
Lead sponsor: Viela Bio (acquired by Horizon Therapeutics)
Sponsor class: INDUSTRY
First posted: 2020-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness
timeFrame: Day 1 (Baseline) through Day 28
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events
timeFrame: Day 1 (Baseline) through Day 70
measure: Change in safety laboratory parameters
timeFrame: Day 1 (Baseline) through Day 70
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Research Site
state: Ohio
Study officials:
affiliation: Vice President, Clinical Development Lead
name: Gábor Illei, MD, PhD, MHS
role: STUDY_DIRECTOR
References: