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NCT04341116 · ClinicalTrials.gov registry record · Phase 2
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
A Phase 2 study, sponsored by I-Mab Biopharma US Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 149
- Enrollment target
NCT04341116: Completed Phase 2 study, sponsored by I-Mab Biopharma US Limited.
NCT04341116 is a Phase 2 study that has completed, run by I-Mab Biopharma US Limited. The registered enrollment target is 149 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04341116, a Phase 2 study, has completed, sponsored by I-Mab Biopharma US Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 149 participants
- Enrollment target
Study 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.
Primary Outcome
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 a
Interventions
- DRUG Placebo
- DRUG TJ003234
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2020-04-11 |
| Est. Completion | 2022-02-07 |
| Phase | Phase 2 |
What the finished NCT04341116 record still lists
NCT04341116 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04341116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04341116 about?
NCT04341116 is a clinical study titled "Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)". 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.
What is the current status of trial NCT04341116?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 149 participants. The study started on 2020-04-11. Estimated completion is 2022-02-07.
What interventions are being tested in trial NCT04341116?
The interventions under investigation include: Placebo (DRUG), TJ003234 (DRUG).
Who is sponsoring clinical trial NCT04341116?
This trial is sponsored by I-Mab Biopharma US Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04341116's enrollment target sits among peer trials
149 491st of 2000 higher than 1,510 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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