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.
Drug: TJ003234
patients receive a single infusion
Drug: Placebo
patients receive a single infusion
Inclusion Criteria:
- Age: 18 years or older (including 18 years); male or female
- Laboratory-confirmed SARS-CoV-2 or COVID-19 infection as determined by polymerase
chain reaction (PCR) or other commercial or public health assay.
- Bilateral lung infection confirmed by imaging.
- Severe disease that meets one of the following conditions: (i) At rest, finger blood
oxygen saturation ≤ 93% or PaO2/FiO2 ≤ 300 mmHg; (ii) Requiring non-invasive or
invasive mechanical ventilation; OR (iii) Requiring high flow oxygen ≥ 15L/min
- Hospitalized for no more than 5 calendar days at the time of screening
Exclusion Criteria:
- Any previous and/or current clinically significant disease or condition that has not
been stable within 3 months prior to enrollment, or acute illness, planned medical/
surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment.
- Chronic obstructive pulmonary disease (COPD) patients requiring inhaled
corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or
long-term oxygen therapy (Part 1 only).
- Pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary
granulomatosis.
- Cardiovascular event in the 3 months prior to study drug administration: acute
myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources
of frequent ventricular premature beat, ventricular tachycardia and ventricular
fibrillation); New York Heart Association Classification (NYHA): Class III-Class IV.
- Blood system disorders or routine blood analysis test abnormalities: Hemoglobin < 8
g/dL; Absolute neutrophil count (ANC) <1500 × 109/L; Platelets < 50 × 109/L.
- Dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day
or more or long-term use of anti-rejection or immunomodulatory drugs.
- Subjects that have been on invasive mechanical ventilation for ≥120 hours at the time
of dosing
- Subjects that require ECMO.
- Pregnant or breastfeeding females.
University of Arkansas
Little Rock, Arkansas, United States
Olive View-UCLA Medical Center
Sylmar, California, United States
Georgetown University Hospital
Washington, District of Columbia, United States
The GW Medical Faculty Associates
Washington, 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
University of Mississippi Medical Center
Jackson, Mississippi, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
UNM Hospitals
Albuquerque, New Mexico, United States
Houston Methodist Hospital
Houston, Texas, United States
Claire Xu, MD, PhD, Study Director
I-Mab Biopharma US Limited