Status:
COMPLETED
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
Lead Sponsor:
I-Mab Biopharma US Limited
Conditions:
Coronavirus Disease 2019 COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2022
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT04341116
Start Date
April 11 2020
End Date
February 7 2022
Last Update
May 6 2023
Active Locations (14)
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1
University of Arkansas
Little Rock, Arkansas, United States, 72205
2
Olive View-UCLA Medical Center
Sylmar, California, United States, 91342
3
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
4
The GW Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037