Trials / Completed
CompletedNCT04341116
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 149 (actual)
- Sponsor
- I-Mab Biopharma US Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TJ003234 | patients receive a single infusion |
| DRUG | Placebo | patients receive a single infusion |
Timeline
- Start date
- 2020-04-11
- Primary completion
- 2022-02-07
- Completion
- 2022-02-07
- First posted
- 2020-04-10
- Last updated
- 2023-05-06
- Results posted
- 2023-05-06
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04341116. Inclusion in this directory is not an endorsement.