Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
- Registration Number
- NCT04341116
- Lead Sponsor
- I-Mab Biopharma US Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - TJ003234 Medium Dose TJ003234 - TJ003234 Low Dose TJ003234 Part 1 only TJ003234 High Dose TJ003234 Part 2 Phase 3 only
- Primary Outcome Measures
Name Time Method Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline Day 1 through Day 30 Free of mechanical ventilation was defined as proportion of subjects who scores 1 to 5 in the following 8-category ordinal scale.
8, death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4, hospitalization with oxygen by mask or nasal prongs; 3. Hospitalization without oxygen supplementation; 2, limitation of activities, discharge from hospital; and 1, no limitation of activities, discharge from hospital.
- Secondary Outcome Measures
Name Time Method Percentage of Recovery by Day 14 Day 1 through Day 14 Sustained recovery in clinical status was defined as patients who have hospitalization without oxygen supplement or discharge from hospital.
Percentage of Subjects Recovered on Day 30 Day 1 through Day 30 Sustained recovery in clinical status was defined as patients who have hospitalization without oxygen supplement or discharge from hospital.
All-cause Mortality Rate by Day 30 Day 1 through Day 30 The percentage of subjects who deceased by any cause.
Time to Recovery Among Subjects Alive by Day 30 Day 1 through Day 30 Time to sustained recovery
Length of Hospitalization Day 1 through Day 30 Duration of hospitalization
Trial Locations
- Locations (14)
UNM Hospitals
🇺🇸Albuquerque, New Mexico, United States
OSF Healthcare Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
Olive View-UCLA Medical Center
🇺🇸Sylmar, California, United States
Indiana University Health
🇺🇸Indianapolis, Indiana, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
The GW Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of Miami
🇺🇸Miami, Florida, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Medpharmics, LLC
🇺🇸Metairie, Louisiana, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States