Trial record 1 of 1 for:
NCT04341116
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
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| ClinicalTrials.gov Identifier: NCT04341116 |
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Recruitment Status :
Recruiting
First Posted : April 10, 2020
Last Update Posted : December 14, 2020
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Sponsor:
I-Mab Biopharma Co. Ltd.
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.
- Study Details
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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 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
MedlinePlus related topics:
Coronavirus Infections
| Arm | Intervention/treatment |
|---|---|
| Experimental: TJ003234 6 mg/kg |
Drug: TJ003234
patients receive a single infusion |
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Experimental: TJ003234 3 mg/kg
Part 1 only
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Drug: TJ003234
patients receive a single infusion |
| Placebo Comparator: Placebo |
Drug: Placebo
patients receive a single infusion |
Primary Outcome Measures :
- Proportion (%) of subjects recovered [ Time Frame: Day 1 through Day 14 ]
Secondary Outcome Measures :
- Proportion (%) of subjects recovered on Day 30 [ Time Frame: Day 1 through Day 30 ]
- All-cause mortality rate by Day 30 [ Time Frame: Day 1 through Day 30 ]
- Time to recovery among subjects alive by Day 30 [ Time Frame: Day 1 through Day 30 ]
- Length of hospitalization [ Time Frame: Day 1 through Day 30 ]
- 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
| Contact: US Site Head | 240-767-6981 | US.Info@I-MabBiopharma.com |
Locations
| United States, California | |
| Olive View-UCLA Medical Center | Recruiting |
| Sylmar, California, United States, 91342 | |
| Contact: Principal Investigator | |
| Principal Investigator: Greg Moran, MD | |
| 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: Kap Sum Foong, 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 | Active, not recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| 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 | Withdrawn |
| Portland, Oregon, United States, 97239 | |
| 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
| Study Director: | Claire Xu, MD, PhD | I-Mab Biopharma US Limited |
| 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: | December 14, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |