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TJ003234Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug1783 Peginterferon Lambda-1A Wiki 0.71
drug2950 placebo Wiki 0.27
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 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)

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.

NCT04341116 Coronavirus Disease 2019 COVID-19 Drug: TJ003234 Drug: Placebo
MeSH:Coronavirus Infections

Primary Outcomes

Description: 8-category ordinal scale

Measure: Proportion (%) of subjects experiencing deterioration in clinical status

Time: Changes from baseline on Day 14

Description: Per CTCAE

Measure: Treatment Emergent Adverse Events

Time: Up to 30 days after drug administration

Secondary Outcomes

Description: 8-category ordinal scale

Measure: Proportion (%) of subjects experiencing deterioration in clinical status

Time: Changes from baseline on Day 7 and Day 30

Description: 8-category ordinal scale: 8, Death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, Intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4,Oxygen by mask or nasal prongs; 3, Hospitalization without oxygen supplementation; 2, Limitation of activities, discharge from hospital; and 1, No limitation of activities, discharge from hospital

Measure: Clinical status

Time: On Day 7, Day 14 and Day 30

Description: 8-category ordinal scale: 8, Death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, Intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4,Oxygen by mask or nasal prongs; 3, Hospitalization without oxygen supplementation; 2, Limitation of activities, discharge from hospital; and 1, No limitation of activities, discharge from hospital

Measure: Improvement in clinical status

Time: On Day 7, Day 14 and Day 30

Description: The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. A higher score predicts a worse clinical outcome.

Measure: Sequential Organ Failure Assessment (SOFA) score

Time: On Day 7 and Day 14

Measure: Change from baseline in PaO2/ FiO2

Time: On Day 7 and Day 14

Description: Defined as SpO2≥94% sustained minimum 24 hours

Measure: Length of time to normalization of oxygen saturation

Time: Up to 30 days after drug administration

Measure: Change from baseline in percentage of subjects requiring mechanical ventilation

Time: On Day 7 and Day 14

Measure: Change from baseline in Glucocorticoid use

Time: On Day 7 and Day 14

Measure: Mortality rate from any cause

Time: Up to 30 days after drug administration

Measure: Length of hospitalization

Time: Up to 30 days after drug administration

Measure: Change from baseline in D-dimer

Time: On Day 7 and Day 14

Measure: Serum concentration of TJ003234

Time: Day 1 predose, Day 1 End of Infusion, Day 7 and Day 14

Measure: Incidence and titer of anti-drug antibodies (ADA)

Time: Day 1 predose, Day 14

No related HPO nodes (Using clinical trials)