A Phase 1b/2, 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)

About this Study

Evaluation of 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.

Sponsor Protocol ID:TJ003234COV201
IRB Number:2020-0092
Actively Enrolling
Interventional
Phase 1
April 16, 2020
Eligibility Criteria
18 years old
Both Male and Female
No
No
No

Inclusion Criteria(1) ≥18 years of age; 
(2) Bilateral lung infection; 
(3) Lab-confirmed SARS-CoV-2 or COVID-19; 
(4) One of the following criteria: (a) severe disease that meets one of the following conditions: (i) Finger blood oxygen saturation ≤ 93% or PaO2/FiO2 ≤ 300 mmHg; or (ii)Requiring non-invasive or invasive mechanical ventilation; or (b) Hospitalized patients ≥60   with medical comorbidities.

Exclusion Criteria(1) COPD patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists or anticholinergics, or long-term oxygen therapy; 
(2) Pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis; 
(3) Cardiovascular event in the prior 3 months; 
(4) Severe renal impairment or liver disease; 
(5) Known hepatitis B or C infection or HIV; 
(6) TB; 
(7) Blood system disorders or abnormalities; 
(8) Dependence on methylprednisolone 2 mg/kg/day or more or long-term use of anti-rejection or immunomodulatory drugs; 
(9) ECMO; and
(10) Pregnancy or breastfeeding.

(Protocol silent on dual enrollment).

Categories Click category to view its trials.
COVID-19 (Coronavirus)
Participating Locations
University Hospital
Contact Information
Contact Name: Heather Vaughn
Phone Number: 601-815-8724
Email: hlvaughn@umc.edu
Principal Investigator:Marshall, Gailen D, M.D.Ph.D., M.D., Ph.D.
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