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

I-Mab Biopharma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Coronavirus Disease 2019 COVID-19

Treatments: Drug: TJ003234; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04341116

TJ003234COV201

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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149 participants in 4 patient groups, including a placebo group

TJ003234 Medium Dose

Experimental group

Treatment:

Drug: TJ003234

TJ003234 Low Dose

Experimental group

Description:

Part 1 only

Treatment:

Drug: TJ003234

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

TJ003234 High Dose

Experimental group

Description:

Part 2 Phase 3 only

Treatment:

Drug: TJ003234