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.

Completed
Coronavirus Disease 2019 COVID-19

Drug: TJ003234

patients receive a single infusion

Drug: Placebo

patients receive a single infusion

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) <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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

I-Mab Biopharma Co. Ltd.
NCT Number
MeSH Terms
COVID-19
Coronavirus Infections
Plonmarlimab