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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341116
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 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
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TJ003234 6 mg/kg Drug: TJ003234
patients receive a single infusion

Experimental: TJ003234 3 mg/kg
Part 1 only
Drug: TJ003234
patients receive a single infusion

Placebo Comparator: Placebo Drug: Placebo
patients receive a single infusion




Primary Outcome Measures :
  1. Proportion (%) of subjects recovered [ Time Frame: Day 1 through Day 14 ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

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


Contacts
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Contact: US Site Head 240-767-6981 US.Info@I-MabBiopharma.com

Locations
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United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Maximiliano Menna    202-444-0371    mpm229@georgetown.edu   
Principal Investigator: Princy Kumar, MD         
The GW Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Contact       msiegel@mfa.gwu.edu   
Principal Investigator: Marc Siegel, MD         
United States, Illinois
OSF Healthcare Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact       skwynn@uic.edu   
Principal Investigator: Joseph Kim, MD         
United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact       chage@iu.edu   
Principal Investigator: Chadi A. Hage, MD         
United States, Louisiana
Medpharmics, LLC Recruiting
Metairie, Louisiana, United States, 70006
Contact       andreajeanfreau@medpharmics.com   
Principal Investigator: Robert Jeanfreau, MD         
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact       idresearch@ochsner.org   
Principal Investigator: Julia Garcia-Diaz, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Ilise Marrazzo       IMarrazzo@ihv.umaryland.edu   
Principal Investigator: Rohit Talwani, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Alexander Hill    617-732-5638    ahill@bwh.harvard.edu   
Principal Investigator: Edward Boyer, MD, PhD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Principal Investigator         
Principal Investigator: John McKinnon, MD         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact       crsp@umc.edu   
Principal Investigator: Gailen D. Marshall, Jr., MD, PhD         
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Robert Bimbi         
Principal Investigator: Shadaba Asad, MD         
United States, New Mexico
UNM Hospitals Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Jon Femling, MD       JFemling@salud.unm.edu   
Principal Investigator: Jon Femling, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Brandon Labadie    971-337-6316    labadie@ohsu.edu   
Principal Investigator: Marcel Curlin, MD         
United States, Pennsylvania
Temple Univeristy Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact       ngentile@temple.edu   
Principal Investigator: Nina Gentile, MD         
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact       dgotur@houstonmethodist.org   
Principal Investigator: Deepa Gotur, MD         
Sponsors and Collaborators
I-Mab Biopharma Co. Ltd.
Investigators
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Study Director: Claire Xu, MD, PhD I-Mab Biopharma US Limited
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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: November 23, 2020
Last Verified: November 2020
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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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases