Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Greg Moran (ucla)

Description

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.

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)

Keywords

Coronavirus Disease 2019 COVID-19 Coronavirus Infections

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • Olive View-UCLA Medical Center accepting new patients
    Sylmar California 91342 United States
  • University Medical Center of Southern Nevada accepting new patients
    Las Vegas Nevada 89102 United States

Lead Scientist at UC Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
I-Mab Biopharma Co. Ltd.
ID
NCT04341116
Phase
Phase 2/3
Study Type
Interventional
Last Updated