CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 149 enrolled
Drug / intervention
TJ003234 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04341116
NCT04341116Phase 3Completed

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)

I-Mab Biopharma US Limited·interventional·Posted Apr 10, 2020·Updated May 6, 2023

In Brief

A Phase 3 clinical trial evaluating TJ003234 and Placebo for Coronavirus Disease 2019 COVID-19. Completed, enrolled 149 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 10, 2020
Enrollment StartApr 11, 2020
Primary CompletionFeb 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.2 years ago

Interventions

TJ003234drug

patients receive a single infusion

Placebodrug

patients receive a single infusion