Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection (NCT04526912) | Clinical Trial Compass
TerminatedPhase 1
Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
Stopped: Study met predefined futility criteria for efficacy endpoints.
United States10 participantsStarted 2020-08-28
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 abse…
What they're measuring
1
The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness