CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


SNDX-6352Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug2656 Virtual Reality Pain Neuroscience Education Wiki 1.00
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 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Axatilimab for the Treatment of Hospitalized Patients With Respiratory Signs and Symptoms Secondary to Novel Coronavirus Disease (COVID-19)

This is a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care, compared with placebo plus standard of care, in patients with respiratory signs and symptoms secondary to novel coronavirus disease (COVID-19).

NCT04415073 Coronavirus COVID ARDS Cytokine Storm Cytokine Release Syndrome Drug: SNDX-6352 Drug: Placebo
MeSH:Coronavirus Infections

Primary Outcomes

Description: Respiratory failure as defined by need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation >6L oxygen/minute, or clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making is driven solely by resource limitation

Measure: Proportion of subjects alive and free of respiratory failure

Time: 29 Days

Secondary Outcomes

Description: Proportion of subjects achieving a ≥ 2 category improvement on 7-point ordinal score relative to the baseline on Day 28 as collected on Day 29

Measure: Secondary clinical improvement outcomes

Time: 29 Days

Description: National early warning score (NEWS) of ≤2 maintained for 24 hours

Measure: Time to clinical improvement (TTCI)

Time: 29 Days

Description: Change from baseline to Day 29 or hospital discharge or death, if sooner, in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen (SpO2/FiO2)

Measure: To evaluate improvement in oxygenation in hospitalized adults with respiratory signs and symptoms secondary to COVID 19 treated with axatilimab

Time: 29 Days

Description: Serum concentrations of IL 6 and c-reactive protein (CRP) change from baseline to Day 15 or hospital discharge or death

Measure: To evaluate changes in biomarkers following treatment with axatilimab

Time: 15 Days

Description: Frequency and severity of AEs and SAEs

Measure: To evaluate the safety and tolerability of axatilimab in the same population

Time: 29 Days

Description: Proportion of subjects who require initiation of mechanical ventilation after study entry

Measure: Ventilation outcomes

Time: 29 Days

Description: Proportion of subjects who are SARS CoV-2 virus free by Day 15 or hospital discharge, whichever is sooner

Measure: To evaluate antiviral effect of axatilimab in hospitalized adults with recently diagnosed SARS CoV-2 infection

Time: Day 15

Description: Serum concentration of axatilimab and presence of anti-drug antibody

Measure: To characterize exposure to axatilimab

Time: 29 Day


No related HPO nodes (Using clinical trials)