Status:
TERMINATED
Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
Lead Sponsor:
Viela Bio
Conditions:
Acute Lung Injury
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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...
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 hospital...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04526912
Start Date
August 28 2020
End Date
May 19 2021
Last Update
December 17 2021
Active Locations (1)
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1
Research Site
Cleveland, Ohio, United States, 44195