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1. I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations

Author

Carolyn S Calfee, Michael A Matthay, Paul Henderson, Martin Eklund, Laura J Esserman, Chirag Patel, Angela Haczku, Michelle Jung, Tony Oliver, Alessio Crippa, Andrea Discacciati, Kathleen D Liu, Ellen L Burnham, Nuala J Meyer, Fady A Youssef, Derek W Russell, Julie Lang, Kevin W Gibbs, Daniel C Files, Sheetal Gandotra, Purnema Madahar, Nathan K Cobb, Timothy E Albertson, Rajiv Sonti, John P Reilly, Alejandra Jauregui, Iván García, Luis E Huerta, Daniel Clark Files, Neil R Aggarwal, Adam L Asare, Jeremy R Beitler, Paul A Berger, George Cimino, Melissa H Coleman, Paul T Henderson, Caroline A G Ittner, Kashif T Khan, Jonathan L Koff, Mary LaRose, Joe Levitt, Ruixiao Lu, Jeffrey D McKeehan, Karl W Thomas, Aaron M Mittel, Albert F Yen, Alexis E Suarez, Alexis L Serra, Alpesh N Amin, Amanda Rosen, Amy L Dzierba, Anna D Barker, Ariel R Weisman, Brian M Daniel, Brian M Morrissey, Caroline AG Ittner, Chayse Jones, Christina Creel-Bulos, Christina M Angelucci, Diana Ng, Fredy Chaparro-Rojas, Gavin H Harris, Harsh V Barot, Heny Su, Jacqueline B Sutter, Jamal Dodin, Jerry S Lee, John Kazianis, Joshua F Detelich, Julie E Lang, Justin Muir, Katarzyna Gosek, Katherine L Nugent, Kimberly Yee, Laura G Rodrigues, Laura R Macias, Lindsey A Orr, Lindsie L Boerger, Lissette Rosario-Remigio, Lucia Kufa, Maged Tanios, Maria B Reyes, Max W Adelman, Maya M Juarez, Michelle Meyers, Mitchell P Sternlieb, Neil Aggarwal, Nilam S Mangalmurti, Patrice Jones, Paul L Saban, Peter S Marshall, Philiip A Robinson, Philip Yang, Rahul Nair, Richard Anthony Lee, Richard G Wunderink, Romina Wahab, Roxana A Lupu, Santhi I Kumar, Sara C Auld, Scott Fields, Se Fum Wong, Skyler J Pearson, Spencer Whealon, Timothy F Obermiller, Anita Darmanian, John Schicchi, Esmeralda Martinez, Farjad Sarafian, Julie Nguyen, Bethany Weiler-Lisowski, Jaime Wyatt, Daniel Blevins, Marylee Melendrez, Brenda Lopez, Hiwet Tzehaie, Omowunmi Amosu, Austin Simonson, Erin Hardy, Brett Lindgren, Gregory Peterfreund, Leigha Landreth, and Lisa Parks

Subjects
Medicine
Abstract

Introduction The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and implemented in early 2020 to evaluate investigational agents rapidly and simultaneously on a phase 2 adaptive platform. This manuscript outlines the design, rationale, implementation and challenges of the ISPY COVID-19 trial during the first phase of trial activity from April 2020 until December 2021.Methods and analysis The ISPY COVID-19 Trial is a multicentre open-label phase 2 platform trial in the USA designed to evaluate therapeutics that may have a large effect on improving outcomes from severe COVID-19. The ISPY COVID-19 Trial network includes academic and community hospitals with significant geographical diversity across the country. Enrolled patients are randomised to receive one of up to four investigational agents or a control and are evaluated for a family of two primary outcomes—time to recovery and mortality. The statistical design uses a Bayesian model with ‘stopping’ and ‘graduation’ criteria designed to efficiently discard ineffective therapies and graduate promising agents for definitive efficacy trials. Each investigational agent arm enrols to a maximum of 125 patients per arm and is compared with concurrent controls. As of December 2021, 11 investigational agent arms had been activated, and 8 arms were complete. Enrolment and adaptation of the trial design are ongoing.Ethics and dissemination ISPY COVID-19 operates under a central institutional review board via Wake Forest School of Medicine IRB00066805. Data generated from this trial will be reported in peer-reviewed medical journals.Trial registration number NCT04488081.

Published
2022
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2. Aortic Root Pseudoaneurysm Caused by Mycobacterium Chimaera

Author

Mitchell P. Sternlieb, Konstadinos A. Plestis, Vishal N. Shah, and Oleg I. Orlov

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Aortic root, Aortic Diseases, Mycobacterium Infections, Nontuberculous, 030204 cardiovascular system & hematology, 03 medical and health sciences, Pseudoaneurysm, 0302 clinical medicine, Aneurysm, Humans, Medicine, Aorta, Aortic dissection, biology, business.industry, Nontuberculous Mycobacteria, Middle Aged, biology.organism_classification, medicine.disease, Surgery, Cardiac surgery, 030228 respiratory system, cardiovascular system, Nontuberculous mycobacteria, Tomography, X-Ray Computed, Cardiology and Cardiovascular Medicine, business, Aneurysm, False, Vascular graft, Mycobacterium
Abstract

Nontuberculous mycobacteria cause severe pulmonary, vascular graft, and bloodstream infections after cardiac surgery. Patient prognosis remains poor because of delays in diagnosis and treatment. Complicated aortic root infections caused by nontuberculous mycobacteria have been mostly fatal. We describe a case of a 50-year-old man who developed an invasive Mycobacterium chimaera infection with an aortic root pseudoaneurysm after a Bentall-de Bono procedure for a Stanford type A aortic dissection.

Published
2019
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3. Dehydration and Rehydration of Carbonated Fluor- and Hydroxylapatite

Author

Zachary Wilt, Demetra V. Schermerhorn, Kimberly N. Worcester, Jill D. Pasteris, Mitchell P. Sternlieb, Claude H. Yoder, and Jennifer E. Goldenberg

Subjects
carbonated apatite, dehydration of apatite, Thermogravimetric analysis, lcsh:QE351-399.2, bone structure, Inorganic chemistry, structural water, rehydration of apatite, chemistry.chemical_element, Calcium, Apatite, chemistry.chemical_compound, Adsorption, medicine, Dehydration, lcsh:Mineralogy, Fluorapatite, Geology, Hydroxylapatite, Geotechnical Engineering and Engineering Geology, medicine.disease, chemistry, visual_art, visual_art.visual_art_medium, Carbonate
Abstract

The recent definitive deuterium solid state NMR spectroscopic evidence for structural water in fluor- and hydroxylapatites has prompted our study of the conditions necessary for the removal and reincorporation of this important structural feature of apatites. Thermal gravimetric analysis of 20 synthetic carbonated calcium hydroxylapatite (CCaApOH) samples and nine carbonated calcium fluorapatite (CCaApF) samples has been used to determine the amount of structural and adsorbed water in each sample. No correlation between the weight percent and number of moles of structural water and the weight percent carbonate in CCaApOH and CCaApF has been found. In contrast, there appears to be a relationship between the amount of adsorbed water and the carbonate concentration in the fluorapatites prepared with a two hour digestion time, as well as in the hydroxylapatites prepared with one hour digestion periods, presumably due to the effect of carbonate on crystallite size. Structural water can be removed from the apatite lattice, primarily above 200 °C, but heating to over 550 °C is required for complete removal. This water can be partly reincorporated through an apparently kinetically-controlled process that is enhanced by an increase in time and/or temperature. We speculate that the incorporation of structural water occurs at the beginning of the formation of the apatite structure, approximately coincident with the incorporation of carbonate. We also speculate that water is both removed and reincorporated by proton transfers from water molecules to hydroxide ions.

Published
2012
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