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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 : May 24, 2021
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 alive and free of mechanical ventilation [ Time Frame: Day 1 through Day 30 ]

Secondary Outcome Measures :
  1. Proportion (%) of subjects who are alive and free of mechanical ventilation at Day 30 among subjects who are free of mechanical ventilation at baseline [ Time Frame: Day 1 through Day 30 ]
  2. All-cause mortality rate by Day 30 [ Time Frame: Day 1 through Day 30 ]
  3. Proportion (%) of subjects recovered on Day 30 [ Time Frame: Day 1 through Day 30 ]
  4. Proportion (%) of subjects recovered on Day 14 [ Time Frame: Day 1 through Day 14 ]
  5. Time to recovery among subjects alive by Day 30 [ Time Frame: Day 1 through Day 30 ]
  6. Length of hospitalization [ Time Frame: Day 1 through Day 30 ]
  7. Incidence of treatment-emergent Adverse events by Day 30 [ Time Frame: Day 1 through Day 30 ]


Information from the National Library of Medicine

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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
Show Show 17 study locations
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: May 24, 2021
Last Verified: May 2021
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