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

NCT ID: NCT04341116

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-11
• Study Completion Date: 2022-02-07

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TJ003234 Medium Dose

Group Type: EXPERIMENTAL

TJ003234

Intervention Type: DRUG

patients receive a single infusion

TJ003234 Low Dose

Part 1 only

Group Type: EXPERIMENTAL

TJ003234

Intervention Type: DRUG

patients receive a single infusion

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

patients receive a single infusion

TJ003234 High Dose

Part 2 Phase 3 only

Group Type: EXPERIMENTAL

TJ003234

Intervention Type: DRUG

patients receive a single infusion

Interventions

TJ003234

patients receive a single infusion

Intervention Type: DRUG

Placebo

patients receive a single infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age: 18 years or older (including 18 years); male or female
• Laboratory-confirmed SARS-CoV-2 or COVID-19 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay.
• Bilateral lung infection confirmed by imaging.
• Severe disease that meets one of the following conditions: (i) At rest, finger blood oxygen saturation ≤ 93% or PaO2/FiO2 ≤ 300 mmHg; (ii) Requiring non-invasive or invasive mechanical ventilation; OR (iii) Requiring high flow oxygen ≥ 15L/min
• Hospitalized for no more than 5 calendar days at the time of screening

Exclusion Criteria

• Any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment.
• Chronic obstructive pulmonary disease (COPD) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (Part 1 only).
• Pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis.
• Cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); New York Heart Association Classification (NYHA): Class III-Class IV.
• Blood system disorders or routine blood analysis test abnormalities: Hemoglobin < 8 g/dL; Absolute neutrophil count (ANC) <1500 × 109/L; Platelets < 50 × 109/L.
• Dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs.
• Subjects that have been on invasive mechanical ventilation for ≥120 hours at the time of dosing
• Subjects that require ECMO.
• Pregnant or breastfeeding females.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I-Mab Biopharma US Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire Xu, MD, PhD

Role: STUDY_DIRECTOR

I-Mab Biopharma US Limited

Locations

University of Arkansas

Little Rock, Arkansas, United States

Olive View-UCLA Medical Center

Sylmar, California, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

The GW Medical Faculty Associates

Washington D.C., District of Columbia, United States

University of Miami

Miami, Florida, United States

OSF Healthcare Saint Francis Medical Center

Peoria, Illinois, United States

Indiana University Health

Indianapolis, Indiana, United States

Medpharmics, LLC

Metairie, Louisiana, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

UNM Hospitals

Albuquerque, New Mexico, United States

Houston Methodist Hospital

Houston, Texas, United States

Countries

United States

References

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Reference Type: DERIVED

PMID: 34473343 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TJ003234COV201

Identifier Type: -

Identifier Source: org_study_id