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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341116
Recruitment Status : Completed
First Posted : April 10, 2020
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 COVID-19 Drug: TJ003234 Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 11, 2020
Actual Primary Completion Date : February 7, 2022
Actual Study Completion Date : February 7, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TJ003234 Medium Dose Drug: TJ003234
patients receive a single infusion
Experimental: TJ003234 Low Dose
Part 1 only
 Drug: TJ003234
patients receive a single infusion
Placebo Comparator: Placebo Drug: Placebo
patients receive a single infusion
Experimental: TJ003234 High Dose
Part 2 Phase 3 only
 Drug: TJ003234
patients receive a single infusion


Outcome Measures
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Primary Outcome Measures :
  1. Proportion (%) of subjects alive and free of mechanical ventilation among subjects who are free of mechanical ventilation at baseline [ Time Frame: Day 1 through Day 30 ]

Secondary Outcome Measures :
  1. Proportion (%) of subjects recovered by Day 14 [ Time Frame: Day 1 through Day 14 ]
  2. Proportion (%) of subjects recovered on Day 30 [ Time Frame: Day 1 through Day 30 ]
  3. All-cause mortality rate by Day 30 [ Time Frame: Day 1 through Day 30 ]
  4. Time to recovery among subjects alive by Day 30 [ Time Frame: Day 1 through Day 30 ]
  5. Length of hospitalization [ Time Frame: Day 1 through Day 30 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341116


Locations
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United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Olive View-UCLA Medical Center
Sylmar, California, United States, 91342
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
The GW Medical Faculty Associates
Washington, District of Columbia, United States, 20037
United States, Florida
University of Miami
Miami, Florida, United States, 33146
United States, Illinois
OSF Healthcare Saint Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Medpharmics, LLC
Metairie, Louisiana, United States, 70006
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Mexico
UNM Hospitals
Albuquerque, New Mexico, United States, 87106
United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
I-Mab Biopharma Co. Ltd.
Investigators
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Study Director: Claire Xu, MD, PhD I-Mab Biopharma US Limited
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: I-Mab Biopharma Co. Ltd.
ClinicalTrials.gov Identifier: NCT04341116    
Other Study ID Numbers: TJ003234COV201
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Plonmarlimab
Anti-Inflammatory Agents
Antiviral Agents
Anti-Infective Agents