Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Coronavirus Disease 2019 COVID-19

In brief

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.

Key facts

Study ID: NCT04341116
Run by: I-Mab Biopharma US Limited
People needed: 149
Starts: 2020-04-11
Expected to finish: 2022-02-07
Last updated by the study team: 2023-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

University of Arkansas — Little Rock, Arkansas, United States
Olive View-UCLA Medical Center — Sylmar, California, United States
Georgetown University Hospital — 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
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

Full record on ClinicalTrials.gov

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