Official Title
A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
Brief Summary

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.

Recruiting
Coronavirus Disease 2019 COVID-19

Drug: TJ003234
patients receive a single infusion
TJ003234 3 mg/kg
TJ003234 6 mg/kg

Drug: Placebo
patients receive a single infusion
Placebo

Eligibility Criteria

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Georgetown University Hospital
Washington, District of Columbia, 20007

Recruiting

Investigator: Maximiliano Menna
Contact: 202-444-0371
mpm229@georgetown.edu

Investigator: Princy Kumar, MD

The GW Medical Faculty Associates
Washington, District of Columbia, 20037

Recruiting

msiegel@mfa.gwu.edu

Investigator: Marc Siegel, MD

OSF Healthcare Saint Francis Medical Center
Peoria, Illinois, 61637

Recruiting

skwynn@uic.edu

Investigator: Joseph Kim, MD

Indiana University Health
Indianapolis, Indiana, 46202

Recruiting

chage@iu.edu

Investigator: Chadi A. Hage, MD

Medpharmics, LLC
Metairie, Louisiana, 70006

Recruiting

andreajeanfreau@medpharmics.com

Investigator: Robert Jeanfreau, MD

Ochsner Medical Center
New Orleans, Louisiana, 70121

Recruiting

idresearch@ochsner.org

Investigator: Julia Garcia-Diaz, MD

University of Maryland Medical Center
Baltimore, Maryland, 21201

Recruiting

Investigator: Ilise Marrazzo
IMarrazzo@ihv.umaryland.edu

Investigator: Rohit Talwani, MD

Brigham and Women's Hospital
Boston, Massachusetts, 02115

Recruiting

Investigator: Alexander Hill
Contact: 617-732-5638
ahill@bwh.harvard.edu

Investigator: Edward Boyer, MD, PhD

Henry Ford Health System
Detroit, Michigan, 48202

Recruiting

Investigator: Principal Investigator

Investigator: John McKinnon, MD

University of Mississippi Medical Center
Jackson, Mississippi, 39216

Recruiting

crsp@umc.edu

Investigator: Gailen D. Marshall, Jr., MD, PhD

University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102

Recruiting

Investigator: Robert Bimbi

Investigator: Shadaba Asad, MD

UNM Hospitals
Albuquerque, New Mexico, 87106

Recruiting

Investigator: Jon Femling, MD
JFemling@salud.unm.edu

Investigator: Jon Femling, MD

Oregon Health and Science University
Portland, Oregon, 97239

Recruiting

Investigator: Brandon Labadie
Contact: 971-337-6316
labadie@ohsu.edu

Investigator: Marcel Curlin, MD

Temple Univeristy Hospital
Philadelphia, Pennsylvania, 19140

Recruiting

ngentile@temple.edu

Investigator: Nina Gentile, MD

Houston Methodist Hospital
Houston, Texas, 77030

Recruiting

dgotur@houstonmethodist.org

Investigator: Deepa Gotur, MD

Contacts

US Site Head
240-767-6981
US.Info@I-MabBiopharma.com

Claire Xu, MD, PhD
Study Director
I-Mab Biopharma US Limited

I-Mab Biopharma Co. Ltd.
NCT Number
MeSH Terms
Coronavirus Infections