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Monoclonal Antibodies
TJ003234 High Dose for COVID-19
Phase 2 & 3
Waitlist Available
Research Sponsored by I-Mab Biopharma Co. Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 30
Awards & highlights
Study Summary
This trial is testing a potential COVID-19 treatment to see if it is safe and effective. The treatment will be given to some people with COVID-19 to see if it reduces the levels of cytokines in their bodies.
Eligible Conditions
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline
Secondary outcome measures
All-cause Mortality Rate by Day 30
Length of Hospitalization
Percentage of Recovery by Day 14
+2 moreSide effects data
From 2022 Phase 2 & 3 trial • 149 Patients • NCT0434111613%
ACUTE KIDNEY INJURY
13%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (Part 2)
TJ003234 3 mg/kg (Part 1)
TJ003234 6mg/kg (Part 1)
TJ003234 6 mg/kg (Part 2)
TJ003234 10mg/kg (Part 2)
Placebo (Part 1)
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: TJ003234 Medium DoseExperimental Treatment1 Intervention
Group II: TJ003234 Low DoseExperimental Treatment1 Intervention
Part 1 only
Group III: TJ003234 High DoseExperimental Treatment1 Intervention
Part 2 Phase 3 only
Group IV: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TJ003234
2019
Completed Phase 3
~190
Find a Location
Who is running the clinical trial?
I-Mab Biopharma Co. Ltd.Lead Sponsor
21 Previous Clinical Trials
2,334 Total Patients Enrolled
Claire Xu, MD, PhDStudy DirectorI-Mab Biopharma US Limited
2 Previous Clinical Trials
130 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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