Phase 3
N=149
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
Coronavirus Disease 2019 COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04341116 ↗Enrolled (actual)
149
Serious AEs
31.5%
Results posted
May 2023
Primary outcome: Primary: Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline — 56; 5; 27 Participants — p=.28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TJ003234 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- I-Mab Biopharma US Limited
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline |
56; 5; 27 | .28 |
| SECONDARY Percentage of Recovery by Day 14 |
47; 5; 20 | — |
| SECONDARY Percentage of Subjects Recovered on Day 30 |
56; 5; 27 | — |
| SECONDARY All-cause Mortality Rate by Day 30 |
7; 1; 9 | — |
| SECONDARY Time to Recovery Among Subjects Alive by Day 30 |
8; 6.5; 10 | — |
| SECONDARY Length of Hospitalization |
10; 9.5; 11 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04341116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.