This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
149
University of Arkansas
Little Rock, Arkansas, United States
Olive View-UCLA Medical Center
Sylmar, California, United States
Georgetown University Hospital
Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline
Free of mechanical ventilation was defined as proportion of subjects who scores 1 to 5 in the following 8-category ordinal scale. 8, death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4, hospitalization with oxygen by mask or nasal prongs; 3. Hospitalization without oxygen supplementation; 2, limitation of activities, discharge from hospital; and 1, no limitation of activities, discharge from hospital.
Time frame: Day 1 through Day 30
Percentage of Recovery by Day 14
Sustained recovery in clinical status was defined as patients who have hospitalization without oxygen supplement or discharge from hospital.
Time frame: Day 1 through Day 14
Percentage of Subjects Recovered on Day 30
Sustained recovery in clinical status was defined as patients who have hospitalization without oxygen supplement or discharge from hospital.
Time frame: Day 1 through Day 30
All-cause Mortality Rate by Day 30
The percentage of subjects who deceased by any cause.
Time frame: Day 1 through Day 30
Time to Recovery Among Subjects Alive by Day 30
Time to sustained recovery
Time frame: Day 1 through Day 30
Length of Hospitalization
Duration of hospitalization
Time frame: Day 1 through Day 30
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Washington D.C., District of Columbia, United States
The GW Medical Faculty Associates
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
OSF Healthcare Saint Francis Medical Center
Peoria, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
Medpharmics, LLC
Metairie, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
...and 4 more locations