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CLINICAL TRIALS AND RESEARCH
The Dallas site was one of 180 hospitals worldwide participating in 2019 and 2020 during the height of the pandemic . Study results indicated that remdesivir helped shorten the illness time and the severity of the COVID-19 virus , decreasing morbidity by 62 %. Dr . Gottlieb also served as chair for the international Trial Guidance and Publication Committee .
Results from the study were published in the New England Journal of Medicine in January 2022 . In addition to studies noted in the listings on prior pages , other key COVID-19 treatment studies in which Dr . Gottlieb served as principal investigator or co-principal investigator in fiscal year 2022 include :
• ACTIV-3 - Therapeutics for Inpatients with COVID-19 ( TICO ) - This study assessed the safety and effectiveness of different drugs in treating COVID-19 in hospitalized people . Participants in the study are treated with either a study drug plus current standard of care ( SOC ), or with placebo plus current SOC . Co-principal investigator with Dr . Gottlieb was Uriel Sebastian Sandkovsky , MD .
• BLAZE-1 - A study of LY3819253 ( LY-COV555 ) and LY3832479 ( LY-COV016 ) in participants with mild to moderate COVID-19 illness - The purpose of this study was to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19 . LY3819253 and LY3832479 is given to participants with early symptoms of COVID-19 .
• BLAZE-4 - A study of immune system proteins in participants with mild to moderate COVID-19 illness - The purpose of this study was to measure how well monoclonal antibodies work , either alone or in combination , against the virus that causes COVID-19 . Of note : BLAZE-4 provided the data for the only currently active treatment-authorized neutralizing monocloncal , bebtelovimab , that retains activity and authorization in the US .
• BREATHE - A study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome secondary to COVID-19 - Gimsilumab is a monoclonal antibody against granulocyte macrophage-colony stimulating factor ( GM-CSF ), which is a myeloid cell growth factor and pro-inflammatory cytokine . This multi-center , adaptive , randomized , doubleblind , placebo-controlled study assessed the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome ( ARDS ) secondary to COVID-19 . In the prior fiscal year , Baylor Dallas was a leading enroller nationwide for this study .
• ENSEMBLE - JNJ SARS-CoV-2 vaccine - A study of Ad26 . COV2 . S for the prevention of SARS-CoV-2- mediated COVID-19 in adults .
• REMDACTA – A study to evaluate the efficacy and safety of remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized participants with severe COVID-19 pneumonia .
• PINETREE - Remdesivir for the treatment of highrisk , non-hospitalized individuals with COVID-19 : a randomized , double-blind , placebo-controlled trial . This phase 3 study evaluated the safety and efficacy of a 3-day course of remdesivir in those participants who were at high risk for disease progression . See more information in New England Journal of Medicine , January 2022 .
BAYLOR SCOTT & WHITE RESEARCH INSTITUTE FORT WORTH SITE
AIM HIGHER – Assessment of implantable cardiac contractility modulation ( CCM ) in the heart failure group with higher ejection fraction . This study aims to evaluate the efficacy and safety of CCM therapy in patients with symptomatic heart failure and ejection fraction in the range of 40 to 60 %. Principal investigator : Alam Mughal , MD .
ALN TTR02 012 – An observational study to evaluate the effectiveness of Patisiran in patients with polyneuropathy of hereditary transthyretinemediated amyloidosis with a V1221 or T60A mutation . Principal investigator : Salman Gohar , MD .
AMPLATZER™ AMULETTM LAA OCCLUDER TRIAL – Designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder . The study participants were randomized in a 1:1 ratio between the Amulet LAA occlusion device ( treatment ) or the Watchman ® LAA closure device ( control ). Study is now in follow-up stage with patients . Principal investigator : Craig Delaughter , MD .
CATALYST – A clinical trial of atrial fibrillation patients to evaluate the safety and effectiveness of the Amulet device compared to NOAC therapy in patients with non-valvular atrial fibrillation at increased risk of ischemic stroke who are recommended for long-term NOAC therapy . Principal investigator : Scott Ewing , DO .
GUIDE-HF - Hemodynamic-Guided Management of Heart Failure study evaluates heart failure patients with recent heart failure hospitalizations and NYHA II or III or IV and the effectiveness of the CardioMEMS HF System device . Principal investigator : Salman Gohar , MD .