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

Purpose

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

  • Coronavirus Disease 2019 COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04341116
Status
Completed
Sponsor
I-Mab Biopharma Co. Ltd.