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Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)

NCT04341116 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2023-05-06

Study results available
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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

  • Coronavirus Disease 2019 COVID-19

Interventions

DRUG

TJ003234

patients receive a single infusion

DRUG

Placebo

patients receive a single infusion

Sponsors & Collaborators

  • I-Mab Biopharma US Limited

    lead INDUSTRY

Principal Investigators

  • Claire Xu, MD, PhD · I-Mab Biopharma US Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-11
Primary Completion
2022-02-07
Completion
2022-02-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04341116 on ClinicalTrials.gov