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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 is a Phase 2 study that has completed, run by I-Mab Biopharma US Limited. The registered enrollment target is 149 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG TJ003234

Trial Details

FieldValue
Enrollment Target 149 participants
Start Date 2020-04-11
Est. Completion 2022-02-07
Phase Phase 2

Sponsor

I-Mab Biopharma US Limited

7 total trials

What the Registry Record Tells You About NCT04341116

The ClinicalTrials.gov registry entry for NCT04341116 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is I-Mab Biopharma US Limited, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04341116 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.