To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
Johns Hopkins Hospital
Baltimore, Maryland, United States
Columbia University
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Regimen related ≥ grade 3 toxicity within 48 hours of first infusion
Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT)
Time frame: 48 hours
28-day treatment success, defined as S28
Alive and not intubated 28 days after the date of first infusion
Time frame: 28 days
Time to extubation
Time to extubation
Time frame: 28 days
Oxygenation improvement
Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11
Time frame: 11 days
Ventilator free days
Ventilator free days measured at day 28
Time frame: 28 days
Organ failure free days
Organ failure free days measured at day 28
Time frame: 28 days
ICU free days
ICU free days measured at day 28
Time frame: 28 days
All-cause mortality
All-cause mortality at day 28
Time frame: 28 days
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Baylor College of Medicine, St Luke's Hospital
Houston, Texas, United States