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)
Georgetown University Hospital
Washington, District of Columbia, 20007
Investigator: Maximiliano Menna
Contact: 202-444-0371
Investigator: Princy Kumar, MD
The GW Medical Faculty Associates
Washington, District of Columbia, 20037
Investigator: Marc Siegel, MD
OSF Healthcare Saint Francis Medical Center
Peoria, Illinois, 61637
Investigator: Joseph Kim, MD
Indiana University Health
Indianapolis, Indiana, 46202
Investigator: Chadi A. Hage, MD
Medpharmics, LLC
Metairie, Louisiana, 70006
Investigator: Robert Jeanfreau, MD
Ochsner Medical Center
New Orleans, Louisiana, 70121
Investigator: Julia Garcia-Diaz, MD
University of Maryland Medical Center
Baltimore, Maryland, 21201
Investigator: Ilise Marrazzo
Investigator: Rohit Talwani, MD
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Investigator: Alexander Hill
Contact: 617-732-5638
Investigator: Edward Boyer, MD, PhD
Henry Ford Health System
Detroit, Michigan, 48202
Investigator: Principal Investigator
Investigator: John McKinnon, MD
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Investigator: Gailen D. Marshall, Jr., MD, PhD
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Investigator: Robert Bimbi
Investigator: Shadaba Asad, MD
UNM Hospitals
Albuquerque, New Mexico, 87106
Investigator: Jon Femling, MD
Investigator: Jon Femling, MD
Oregon Health and Science University
Portland, Oregon, 97239
Investigator: Brandon Labadie
Contact: 971-337-6316
Investigator: Marcel Curlin, MD
Temple Univeristy Hospital
Philadelphia, Pennsylvania, 19140
Investigator: Nina Gentile, MD
Houston Methodist Hospital
Houston, Texas, 77030
Investigator: Deepa Gotur, MD
US Site Head
240-767-6981
US.Info@I-MabBiopharma.com
Claire Xu, MD, PhD
Study Director
I-Mab Biopharma US Limited