Digital Commons Network^™

Effect Of Pioglitazone On Inflammatory Response And Clinical Outcome In T2dm Patients With Covid-19: A Randomized Multicenter Double-Blind Clinical Trial, Khaled Baagar, Thamer Alessa, Mohamed Abu-Farha, Jehad Abubaker, Heba Alhumaidi, Jose Antonio Franco Ceruto, Mohammad Khair Hamad, Ali Omrani, Salma Abdelrahman, Muhammad Zaka-Ul Haq, Abdul Wajid Safi, Bassem Alhariri, Manish Barman, Alaaeldin Abdelmajid, Humberto Vidal Denis Cancio, Eman Elmekaty, Irina Al-Khairi, Preethi Cherian, Lina Jayyousi, Mohammed Ahmed, Mohammed Qaddoumi, Sulaiman Hajji, Ahmad Esmaeel, Ali Al-Andaleeb, Arshad Channanath, Sriraman Devarajan, Hamad Ali, Thangavel Alphonse Thanaraj, Salman Al-Sabah, Fahd Al-Mulla, Muhammad Abdul-Ghani, Amin Jayyousi

Faculty, Staff and Student Publications

Background: Coronavirus disease 2019 (COVID-19) caused by the coronavirus SARS-CoV-2, has emerged as a rapidly spreading contagious disease across the globe. Recent studies showed that people with diabetes mellitus, severe obesity, and cardiovascular disease are at higher risk of mortality from COVID-19. It has been suggested that the increased risk is due to the chronic inflammatory state associated with type 2 diabetes. This study aimed to evaluate the efficacy of pioglitazone, a strong insulin sensitizer with anti-inflammatory properties, in improving the clinical outcomes of patients with type 2 diabetes admitted with moderate-severe COVID-19.

Method: We enrolled 350 patients with type …

Risk Stratification And Prediction Of Severity Of Covid-19 Infection In Patients With Preexisting Cardiovascular Disease, Stanislava Matejin, Igor D Gregoric, Rajko Radovancevic, Slobodan Paessler, Vladimir Perovic

Faculty, Staff and Student Publications

Introduction: Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 is a highly contagious viral disease. Cardiovascular diseases and heart failure elevate the risk of mechanical ventilation and fatal outcomes among COVID-19 patients, while COVID-19 itself increases the likelihood of adverse cardiovascular outcomes.

Methods: We collected blood samples and clinical data from hospitalized cardiovascular patients with and without proven COVID-19 infection in the time period before the vaccine became available. Statistical correlation analysis and machine learning were used to evaluate and identify individual parameters that could predict the risk of needing mechanical ventilation and patient survival.

Results: Our results confirmed that COVID-19 …

Synergistic Effects Of Β-Nafeo2 Ferrite Nanoparticles For Photocatalytic Degradation, Antibacterial, And Antioxidant Applications†, Forsad Al Hossain, M Tanjid Hasan Tonmoy, Sri Nuvvula, Brittany P Chapman, Rajesh K Gupta, Andrew A Lover, Rhoel R Dinglasan, Stephanie Carreiro, Tauhidur Rahman

Faculty, Staff and Student Publications

Syndromic surveillance is an effective tool for enabling the timely detection of infectious disease outbreaks and facilitating the implementation of effective mitigation strategies by public health authorities. While various information sources are currently utilized to collect syndromic signal data for analysis, the aggregated measurement of cough, an important symptom for many illnesses, is not widely employed as a syndromic signal. With recent advancements in ubiquitous sensing technologies, it becomes feasible to continuously measure population-level cough incidence in a contactless, unobtrusive, and automated manner. In this work, we demonstrate the utility of monitoring aggregated cough count as a syndromic indicator to …

The Uprmt Preserves Mitochondrial Import To Extend Lifespan, Jolaade Kalinowski, Elizabeth A Hintz, Chigozirim Izeogu

Faculty, Staff and Student Publications

The SARS-CoV-2 (COVID-19) pandemic introduced many challenges and nuances that have transformed medical practice and research. The uncertainty caused by COVID-19 led to inevitable challenges to patient-provider relationships. The ever-changing landscape of COVID-19 research and policy proved to be challenging for the medical community and patients. These challenges also exacerbated long-standing issues regarding patient-provider communication and trust. On the other hand, these challenges gave voice to a burgeoning patient advocacy community. Through social media, advocacy and patient organizing, patients harnessed their power and organized over challenges relating to COVID-19 fears and concerns, ramifications of "Long COVID," and much more. During …

Accelerate Vaccine Development Using Seamless Phase 2/3 Trial Designs, Jia-Ying Yang, Guo-Chun Li, Ying Yuan

Faculty, Staff and Student Publications

Background: Traditional vaccine development, often a lengthy and costly process of three separated phases. However, the swift development of COVID-19 vaccines highlighted the critical importance of accelerating the approval of vaccines. This article showcases a seamless phase 2/3 trial design to expedite the development process, particularly for multi-valent vaccines.

Research design and methods: This study utilizes simulation to compare the performance of seamless phase 2/3 design with that of conventional trial design, specifically by re-envisioning a 9-valent HPV vaccine trial. Across three cases, several key performance metrics are evaluated: overall power, type I error rate, average sample size, trial duration, …

Exposure To Urban Green Spaces And Mental Health During The Covid-19 Pandemic: Evidence From Two Low And Lower-Middle-Income Countries, Muhammad Mainuddin Patwary, Mondira Bardhan, Hüseyin Ertan İnan, Matthew H E M Browning, Asma Safia Disha, Md Zahidul Haque, Mai Helmy, Sadia Ashraf, Angel M Dzhambov, Faysal Kabir Shuvo, Md Ashraful Alam, Sharif Mutasim Billah, Md Pervez Kabir, Md Riad Hossain, Md Golam Azam, Md Mijanur Rahman, Sarya Swed, Ranjit Sah, Juan J Montenegro-Idrogo, D Katterine Bonilla-Aldana, Alfonso J Rodriguez-Morales

Faculty, Staff and Student Publications

INTRODUCTION: The COVID-19 pandemic has had a significant impact on mental health globally, with limited access to mental health care affecting low- and middle-income countries (LMICs) the most. In response, alternative strategies to support mental health have been necessary, with access to green spaces being a potential solution. While studies have highlighted the role of green spaces in promoting mental health during pandemic lockdowns, few studies have focused on the role of green spaces in mental health recovery after lockdowns. This study investigated changes in green space access and associations with mental health recovery in Bangladesh and Egypt across the …

Health And Education Services During The Covid-19 Pandemic Among Young Children With Autism Spectrum Disorder And Other Developmental Disabilities., Karen Pazol, Lin H. Tian, Carolyn Diguiseppi, Maureen S. Durkin, M Daniele Fallin, Eric J. Moody, Cy Nadler, Patrick S. Powell, Nuri Reyes, Britney Robinson, A Blythe Ryerson, Joann M. Thierry, Sarah C. Tinker, Lisa D. Wiggins, Marshalyn Yeargin-Allsopp

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVE: Understanding how the COVID-19 pandemic affected children with disabilities is essential for future public health emergencies. We compared children with autism spectrum disorder (ASD) with those with another developmental disability (DD) and from the general population (POP) regarding (1) missed or delayed appointments for regular health/dental services, immunizations, and specialty services; (2) reasons for difficulty accessing care; and (3) use of remote learning and school supports.

METHOD: Caregivers of children previously enrolled in the Study to Explore Early Development, a case-control study of children with ASD implemented during 2017 to 2020, were recontacted during January-June 2021 to learn about …

Differing Impacts Of The Covid-19 Pandemic On Farmers And Intermediaries: Insights Into The Ecuadorian Cocoa Value Chain, Guillermo Zambrano, Lina M Tennhardt, Moritz Egger, Karen Ramírez, Adriana Santos, Byron Moyano, Michael Curran

Faculty, Staff and Student Publications

The COVID-19 pandemic generated diverse impacts and responses in agricultural value chains worldwide. Cocoa is a key crop for Ecuadorian exports, and the analysis of effects the pandemic had on value chain actors contributes to the understanding of their individual capacities to coping with a major shock. The purpose of this study was to assess the number and severity of impacts and responses implemented by two links in the cocoa value chain to the pandemic, based on a survey of 158 cocoa farmers and 52 cocoa intermediaries from the main cocoa-producing provinces of the northern coast of Ecuador in 2021. …

Graduate Public Health Student Learning Experiences, Social Connectedness, And Mental Health During Covid-19: Pedagogical Implications For Public Health Academic Departments, Harit Agroia, Rachel Berkowitz, Andrew Carter, Vicky Gomez, Monica Allen

Faculty Research, Scholarly, and Creative Activity

Introduction: The COVID-19 pandemic impacted college student learning both globally and nationally. Current literature points to decreases in social connectedness, adverse mental health outcomes, and decreased overall learning outcomes; however, there are limited findings from higher education institutions within the Bay Area, California. There are also limited studies that examine the COVID-19 impact among public health graduate students, especially to understand how the pandemic renewed their interest in the field. The purpose of this study was to investigate the effects of COVID-19 on graduate student learning experiences, social connectedness and mental health within the Master of Public Health program at …

Scoping Review: The Effects Of Interrupted Onabotulinumtoxin A Treatment For Chronic Migraine Prevention During The Covid-19 Pandemic, Qing Zhao Ruan, Daniel J Pak, Amitabh Gulati, Moises Dominguez, Sudhir Diwan, Jamal Hasoon, Timothy R Deer, R Jason Yong, Abdulrazaq Albilali, Amanda Macone, Sait Ashina, Christopher L Robinson

Faculty, Staff and Student Publications

Objective: To systematically examine the literature on the clinical consequences of inadvertent delays in scheduled onabotulinumtoxin A (OTA) therapy for chronic migraine during the COVID-19 pandemic and assess recommendations when access to OTA is limited.

Background: The coronavirus (COVID-19) pandemic was unprecedented in its impact on the global medical community. Most healthcare institutions in the United States (US) and the world had begun significantly limiting elective procedures, undermining management of many debilitating chronic conditions. OTA injections, were similarly involuntarily postponed, leading to significant setbacks in symptom control.

Methods: A comprehensive literature search was conducted on databases of Medline and Embase …

Post-Covid-19 Cognitive Symptoms In Patients Assisted By A Teleassistance Service: A Retrospective Cohort Study, Lívia Paula Freire Bonfim, Thais Rotsen Correa, Bruno Cabaleiro Cortizo Freire, Thais Marques Pedroso, Daniella Nunes Pereira, Thalita Baptisteli Fernandes, Luciane Kopittke, Clara Rodrigues Alves De Oliveira, Antonio Lucio Teixeira, Milena Soriano Marcolino

Faculty, Staff and Student Publications

INTRODUCTION: Four years after the onset of the COVID-19 pandemic, the frequency of long-term post-COVID-19 cognitive symptoms is a matter of concern given the impact it may have on the work and quality of life of affected people.

OBJECTIVE: To evaluate the incidence of post-acute COVID-19 cognitive symptoms, as well as the associated risk factors.

METHODS: Retrospective cohort, including outpatients with laboratory-confirmed COVID-19 and who were assisted by a public telehealth service provided by the Telehealth Network of Minas Gerais (TNMG), during the acute phase of the disease, between December/2020 and March/2022. Data were collected through a structured questionnaire, applied …

Screening For Food And Nutrition Insecurity In The Healthcare Setting: A Cross-Sectional Survey Of Non-Medicaid Insured Adults In An Integrated Healthcare Delivery System, Carmen Byker Shanks, Nancy P Gordon

Faculty, Staff and Student Publications

OBJECTIVES: Healthcare screening identifies factors that impact patient health and well-being. Hunger as a Vital Sign (HVS) is widely applied as a screening tool to assess food security. However, there are no common practice screening questions to identify patients who are nutrition insecure or acquire free food from community-based organizations. This study used self-reported survey data from a non-Medicaid insured adult population approximately one year after the start of the COVID-19 pandemic (2021). The survey examined the extent to which the HVS measure might have under-estimated population-level food insecurity and/or nutrition insecurity, as well as under-identified food and nutrition insecurity …

Practice Patterns Of Cardiovascular Magnetic Resonance Use In The Diagnosis Of Pediatric Myocarditis: A Survey-Based Study, Hannah M Jacobs, Jonathan H Soslow, Matthew D Cornicelli, Shae A Merves, Ruchira Garg, Mehul D Patel, Arpit Agarwal, Nilanjana Misra, Michael P Dilorenzo, M Jay Campbell, Jeremy Steele, Jennifer Co-Vu, Joshua D Robinson, Simon Lee, Jason N Johnson

Faculty, Staff and Student Publications

Background: Cardiovascular magnetic resonance (CMR) is used to diagnose myocarditis in adults and children based on the original Lake Louise criteria (LLC) and more recently the revised LLC. The major change included in the revised LLC was the incorporation of parametric mapping, which significantly increases the sensitivity and specificity of diagnosis. Subsequently, scientific statements have recommended the use of parametric mapping in the diagnosis of myocarditis in children. However, there are some challenges to parametric mapping that are unique to the pediatric population. Our goal is to characterize clinical CMR and parametric mapping practice patterns for the diagnosis of myocarditis …

Understanding The Experience Of Mothers In Higher Education During The Covid-19 Era, Shannan L. Engel

Antioch University Dissertations & Theses

This exploratory study aimed to understand the experience of mothers in higher education both during the COVID-19 pandemic and toward the end of restrictions. The population included academic mothers with children at home during the pandemic. Data was analyzed thematically by a team of researchers. The results generated six themes: (a) life changed suddenly, (b) remote work, school, and life, (c) unsupported, (d) sense of control, (e) support, and (f) positive aspects of COVID. These findings are important to the field of mental health counseling profession, supervision, and higher education because of the circumstances exemplified by the pandemic that highlight …

Development, Implementation, And Evaluation Of Three Outreach Events To Improve Covid-19 Vaccine Uptake Among Racial And Ethnic Minority Communities In Houston, Texas, 2022, Carmin Munoz-Lavanderos, Abiodun Oluyomi, Omar Rosales, Norvin Hernandez, Nana Mensah-Bonsu, Hoda Badr

Faculty, Staff and Students Publications

OBJECTIVES: Lack of access to timely, accurate, and linguistically appropriate COVID-19 information has complicated the dissemination of evidence-based information and contributed to vaccine hesitancy among racial and ethnic minority groups in the United States. We developed community events that provided outreach, education, and access to COVID-19 vaccination to overcome vaccine hesitancy in these communities.

METHODS: Using spatial analysis techniques, we identified 3 communities with low vaccine uptake in Houston, Texas, in fall 2021; engaged 20 stakeholders from these communities via 4 focus groups to understand barriers to vaccination; and developed and implemented 3 COVID-19 vaccine education and outreach events tailored …

Effects Of Covid-19 On Sleep Services Use And Its Recovery, Amin Ramezani, Amir Sharafkhaneh, Ahmed S Bahammam, Samuel T Kuna, Javad Razjouyan

Faculty, Staff and Students Publications

PURPOSE: The COVID-19 pandemic affected the utilization of various healthcare services differentially. Sleep testing services utilization (STU), including Home Sleep Apnea Testing (HSAT) and Polysomnography (PSG), were uniquely affected. We assessed the effects of the pandemic on STU and its recovery using the Veterans Health Administration (VHA) data.

PATIENTS AND METHODS: A retrospective cohort study from the VHA between 01/2019 and 10/2023 of veterans with age ≥ 50. We extracted STU data using Current Procedural Terminology codes for five periods based on STU and vaccination status: pre-pandemic (Pre-Pan), pandemic sleep test moratorium (Pan-Mor), and pandemic pre-vaccination (Pan-Pre-Vax), vaccination (Pan-Vax), and …

Changes In Patterns Of Referral For Inpatient Rehabilitation Cancer Patients Due To Covid-19: A Retrospective Study, Ekta Gupta, Amy H Ng, Aline Rozman De Moraes, Jack B Fu, Jegy M Tennison, Maaheen Ahmed, Bryan M Fellman, Eduardo Bruera

Faculty, Staff and Students Publications

There is a paucity of literature on the effect of COVID-19 on hospital processes. We hypothesized that COVID-19 was associated with decreased cancer physiatry referrals in 2020. This is a retrospective cohort study of consecutive patients from April to July 2019 and 2020 admitted at an academic quaternary cancer center. The main outcomes were number of hospital admissions, rate, and characteristics of inpatient rehabilitation admissions and change in percentage of physiatry referrals as the primary endpoint. Results showed that in 2019, there were 387 referrals from 10,274 inpatient admissions (3.8%; 95% confidence interval, 2.4-4.2), compared with 337 referrals from 7051 …

The Seroprevalence Of Sars-Cov-2-Specific Antibodies In Australian Children: A Cross-Sectional Study, Archana Koirala, Jocelynne Mcrae, Philip N Britton, Marnie Downes, Shayal A Prasad, Suellen Nicholson, Noni E Winkler, Matthew V N O'Sullivan, Fatima Gondalwala, Cecile Castellano, Emma Carey, Alexandra Hendry, Nigel Crawford, Ushma Wadia, Peter Richmond, Helen S Marshall, Julia E Clark, Joshua R Francis, Jeremy Carr, Adam Bartlett, Brendan Mcmullan, Justin Skowno, Donald Hannah, Andrew Davidson, Britta S Von Ungern-Sternberg, Paul Lee-Archer, Laura L Burgoyne, Edith B Waugh, John B Carlin, Zin Naing, Nicole Kerly, Alissa Mcminn, Guillian Hunter, Christine Heath, Natascha D'Angelo, Carolyn Finucane, Laura A Francis, Sonia Dougherty, William Rawlinson, Theo Karapanagiotidis, Natalie Cain, Rianne Brizuela, Christopher C Blyth, Nicholas Wood, Kristine Macartney

Staff and Researcher Publications

Background: Following reduction of public health and social measures concurrent with SARS-CoV-2 Omicron emergence in late 2021 in Australia, COVID-19 case notification rates rose rapidly. As rates of direct viral testing and reporting dropped, true infection rates were most likely to be underestimated.

Objective: To better understand infection rates and immunity in this population, we aimed to estimate SARS-CoV-2 seroprevalence in Australians aged 0-19 years.

Methods: We conducted a national cross sectional serosurvey from June 1, 2022, to August 31, 2022, in children aged 0-19 years undergoing an anesthetic procedure at eight tertiary pediatric hospitals. Participant questionnaires were administered, and …

Optimizing Immunogenicity And Product Presentation Of A Sars-Cov-2 Subunit Vaccine Composition: Effects Of Delivery Route, Heterologous Regimens With Self-Amplifying Rna Vaccines, And Lyophilization, William R Lykins, Jeroen Pollet, Jessica A White, Brian Keegan, Leroy Versteeg, Ulrich Strych, Wen-Hsiang Chen, Raodoh Mohamath, Gabi Ramer-Denisoff, Sierra Reed, Christina Renshaw, Samuel Beaver, Alana Gerhardt, Emily A Voigt, Mark A Tomai, Robert Sitrin, Robert K M Choy, Frederick J Cassels, Peter J Hotez, Maria Elena Bottazzi, Christopher B Fox

Faculty, Staff and Students Publications

INTRODUCTION: Dozens of vaccines have been approved or authorized internationally in response to the ongoing SARS-CoV-2 pandemic, covering a range of modalities and routes of delivery. For example, mucosal delivery of vaccines via the intranasal (i.n.) route has been shown to improve protective mucosal responses in comparison to intramuscular (i.m.) delivery. As we gain knowledge of the limitations of existing vaccines, it is of interest to understand if changes in product presentation or combinations of multiple vaccine modalities can further improve immunological outcomes.

METHODS: We investigated a commercial-stage SARS-CoV-2 receptor binding domain (RBD) antigen adjuvanted with a clinical-stage TLR-7/8 agonist …

Targeting Sars-Cov-2 Nonstructural Protein 3: Function, Structure, Inhibition, And Perspective In Drug Discovery, Xin Li, Yongcheng Song

Faculty, Staff and Students Publications

As a highly contagious human pathogen, severe acute respiratory syndrome-associated coronavirus-2 (SARS-CoV-2) has infected billions of people worldwide with more than 6 million deaths. With several effective vaccines and antiviral drugs now available, the SARS-CoV-2 pandemic been brought under control. However, a new pathogenic coronavirus could emerge in the future, given the zoonotic nature of this virus. Natural evolution and drug-induced mutations of SARS-CoV-2 also require continued efforts for new anti-coronavirus drugs. Nonstructural protein (nsp) 3 of CoVs is a large, multifunctional protein, containing a papain-like protease (PLpro) and a macrodomain (Mac1), which are essential for viral replication. Here, we …

Changes In Psychiatric Diagnosis Associated With Sars-Cov-2 Infection And Predicting The Development Of New Psychiatric Illness In Covid Patients By Using Machine Learning Approach: A Study Using The Us National Covid Cohort Collaborative (N3c), Asif Rahman

Graduate Theses, Dissertations, and Problem Reports (ETD)

The enduring impact of COVID-19 extends beyond acute illness, with potential long-term psychiatric consequences raising significant concern among healthcare professionals and researchers alike. Emerging evidence suggests a multifaceted relationship between COVID-19 and the development of different psychiatric illnesses like Schizophrenia Spectrum and Psychotic Disorders (SSPD), Depression, Bipolar disorder, Personality disorder, Trauma, and a range of other mental health conditions. Considering these emerging connections, our study endeavors to rigorously assess the associations between COVID-19 and various psychiatric illnesses while simultaneously employing machine learning techniques to predict the development of new psychiatric disorders in individuals affected by the virus. Leveraging the extensive …

Covid-19 Vaccination-Related Tinnitus Is Associated With Pre-Vaccination Metabolic Disorders, Weihua Wang, Anusha Yellamsetty, Robert M. Edmonds, Shaun R. Barcavage, Shaowen Bao

Faculty Research, Scholarly, and Creative Activity

Cases of tinnitus have been reported following administration of COVID-19 vaccines. The aim of this study was to characterize COVID-19 vaccination-related tinnitus to assess whether there is a causal relationship, and to examine potential risk factors for COVID-19 vaccination-related tinnitus. We analyzed a survey on 398 cases of COVID-19 vaccination-related tinnitus, and 699,839 COVID-19 vaccine-related reports in the Vaccine Adverse Effect Reporting System (VAERS) database that was retrieved on 4 December 2021. We found that following COVID-19 vaccination, 1) tinnitus report frequencies for Pfizer, Moderna and Janssen vaccines in VAERS are 47, 51 and 70 cases per million full vaccination; …

'Man's Forgotten Friend': Dogs Appointed As Domesticated Companions And The Coronavirus Pandemic, Rebekah Gregory

School of Law, Humanities and Social Sciences Theses

The metaphorical confinement of national lockdowns saw the egocentric adoption of dogs appointed as domesticated companions. While public approval of ‘animal’ welfare legislation and the growing popularity of ‘green’ theory and industry has grown, ‘animals’ are still victim to the consumer and the anthropocentric cultures which promote individual, economic, social, and specifically ‘human’ advancement at all costs. Even though the reasons why ‘animals’ are victimised has been researched, how the pandemic has impacted upon this treatment and consumer culture’s/anthropocentrism’s influence has been somewhat absent within academic discussion. In fact, how the global events of COVID-19 have impacted upon dog treatment, …

Contested Spaces: An Interdisciplinary Collaboration, Lyndall Adams, Nicola Kaye, Marcella Polain, Emma Jayakumar

Research outputs 2022 to 2026

The world in 2020 presented Australia with a world on fire, in lock down, and in environmental ruin, with potentially unprecedented social dislocation, homelessness, unemployment and mental health issues. Four artists reaction was to collaborate in an attempt to make sense of the complex COVID-19 context that was unfolding in front of them. Their interdisciplinary collaboration resulted in the multimedia artwork: Contested Spaces. Two iterations of the artwork (2020 and 2021) were exhibited as the artists navigated the unfolding spaces inhabited as they learnt to live and cope under the strictures of COVID-19. The 2021 iteration, was part of a …

Lessons Learned: Drive-Through Covid-19 Clinic Testing During An Adaptive Epidemic Response And A Point-Of-Care Test Assessment Of A Computer-Read Rapid Lateral Flow Immunoassay With Fluorescence-Based Detection, Leah Rankine-Wilson, Teresa Oncken, Irshan Basrewan, Courtney Jeffery, Todd M. Pryce, Rebecca Wake, Aus A.L. Molan, T. F. Paton, Tim J.J. Inglis

Research outputs 2022 to 2026

Background. The COVID-19 pandemic demonstrated a need for robust SARS-CoV-2 test evaluation infrastructure to underpin biosecurity and protect the population during a pandemic health emergency. Gap statement. The first generation of rapid antigen tests was less accurate than molecular methods due to their inherent sensitivity and specificity shortfalls, compounded by the consequences of self-testing. This created a need for more accurate point-of-care SARS-CoV-2 detection methods. Aim. Here we present the lessons-learned during the COVID-19 emergency response in Western Australia including the detailed set-up, evaluation and operation of rapid antigen test in a state-run drive-through sample collection service during the COVID-19 …

Creating A Plasma Coordination Center To Support Covid-19 Outpatient Trials Across A National Network Of Hospital Blood Banks, Anusha Yarava, Christi Marshall, David E Reichert, Aaron Ye, Preeti Khanal, Sanford H Robbins, Bruce S Sachais, David Oh, Ryan A Metcalf, Kathleen Conry-Cantilena, Karen King, Meredith Reyes, Jill Adamski, Marisa B Marques, Minh-Ha Tran, Elizabeth S Allen, Daniel Pach, Neil Blumberg, Rhonda Hobbs, Tammon Nash, Aarthi G Shenoy, Giselle S Mosnaim, Yuriko Fukuta, Bela Patel, Sonya L Heath, Adam C Levine, Barry R Meisenberg, Shweta Anjan, Moises A Huaman, Janis E Blair, Judith S Currier, James H Paxton, William Rausch, Kevin Oei, Matthew Abinante, Donald N Forthal, Martin S Zand, Seble G Kassaye, Edward R Cachay, Kelly A Gebo, Shmuel Shoham, Arturo Casadevall, Nichol A Mcbee, Daniel Amirault, Ying Wang, Erica Hopkins, David M Shade, Oliver Layendecker, Sabra L Klein, Han-Sol Park, John S Lee, Patrizio Caturegli, Jay S Raval, Daniel Cruser, Alyssa F Ziman, Jonathan Gerber, Thomas J Gniadek, Evan M Bloch, Aaron A R Tobian, Daniel F Hanley, David J Sullivan, Karen Lane

Faculty, Staff and Students Publications

INTRODUCTION: In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.

METHODS: A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.

RESULTS: We performed 1,351 transfusions in …

Early Immune Factors Associated With The Development Of Post-Acute Sequelae Of Sars-Cov-2 Infection In Hospitalized And Non-Hospitalized Individuals, Jacqueline M Leung, Michelle J Wu, Pouya Kheradpour, Chen Chen, Katherine A Drake, Gary Tong, Vanessa K Ridaura, Howard C Zisser, William A Conrad, Natalia Hudson, Jared Allen, Christopher Welberry, Celine Parsy-Kowalska, Isabel Macdonald, Victor F Tapson, James N Moy, Christopher R Defilippi, Ivan O Rosas, Mujeeb Basit, Jerry A Krishnan, Sairam Parthasarathy, Bellur S Prabhakar, Mirella Salvatore, Charles C Kim

Faculty, Staff and Students Publications

BACKGROUND: Infection by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can lead to post-acute sequelae of SARS-CoV-2 (PASC) that can persist for weeks to years following initial viral infection. Clinical manifestations of PASC are heterogeneous and often involve multiple organs. While many hypotheses have been made on the mechanisms of PASC and its associated symptoms, the acute biological drivers of PASC are still unknown.

METHODS: We enrolled 494 patients with COVID-19 at their initial presentation to a hospital or clinic and followed them longitudinally to determine their development of PASC. From 341 patients, we conducted multi-omic profiling on peripheral blood …

Using Randomization Tests To Address Disruptions In Clinical Trials, Diane Uschner, Oleksandr Sverdlov, Kerstine Carter, Jonathan Chipman, Olga Kuznetsova, Jone Renteria, Adam Lane, Chris Barker, Nancy Geller, Michael Proschan, Martin Posch, Sergey Tarima, Frank Bretz, William F. Rosenberger

Biostatistics Faculty Publications

Recent examples for unplanned external events are the global COVID-19 pandemic, the war in Ukraine, or most recently Hurricane Ian in Puerto Rico. Disruptions due to unplanned external events can lead to violation of assumptions in clinical trials. In certain situations, randomization tests can provide nonparametric inference that is robust to violation of the assumptions usually made in clinical trials. The ICH E9 (R1) Addendum on estimands and sensitivity analyses provides a guideline for aligning the trial objectives with strategies to address disruptions in clinical trials. In this article, we embed randomization tests within the estimand framework to allow for …

Researching Covid To Enhance Recovery (Recover) Pediatric Study Protocol: Rationale, Objectives And Design, Rachel S Gross, Tanayott Thaweethai, Erika B Rosenzweig, James Chan, Lori B Chibnik, Mine S Cicek, Amy J Elliott, Valerie J Flaherman, Andrea S Foulkes, Margot Gage Witvliet, Richard Gallagher, Maria Laura Gennaro, Terry L Jernigan, Elizabeth W Karlson, Stuart D Katz, Patricia A Kinser, Lawrence C Kleinman, Michelle F Lamendola-Essel, Joshua D Milner, Sindhu Mohandas, Praveen C Mudumbi, Jane W Newburger, Kyung E Rhee, Amy L Salisbury, Jessica N Snowden, Cheryl R Stein, Melissa S Stockwell, Kelan G Tantisira, Moriah E Thomason, Dongngan T Truong, David Warburton, John C Wood, Shifa Ahmed, Almary Akerlundh, Akram N Alshawabkeh, Brett R Anderson, Judy L Aschner, Andrew M Atz, Robin L Aupperle, Fiona C Baker, Venkataraman Balaraman, Dithi Banerjee, Deanna M Barch, Arielle Baskin-Sommers, Sultana Bhuiyan, Marie-Abele C Bind, Amanda L Bogie, Tamara Bradford, Natalie C Buchbinder, Elliott Bueler, Hülya Bükülmez, B J Casey, Linda Chang, Maryanne Chrisant, Duncan B Clark, Rebecca G Clifton, Katharine N Clouser, Lesley Cottrell, Kelly Cowan, Viren D'Sa, Mirella Dapretto, Soham Dasgupta, Walter Dehority, Audrey Dionne, Kirsten B Dummer, Matthew D Elias, Shari Esquenazi-Karonika, Danielle N Evans, E Vincent S Faustino, Alexander G Fiks, Daniel Forsha, John J Foxe, Naomi P Friedman, Greta Fry, Sunanda Gaur, Dylan G Gee, Kevin M Gray, Stephanie Handler, Ashraf S Harahsheh, Keren Hasbani, Andrew C Heath, Camden Hebson, Mary M Heitzeg, Christina M Hester, Sophia Hill, Laura Hobart-Porter, Travis K F Hong, Carol R Horowitz, Daniel S Hsia, Matthew Huentelman, Kathy D Hummel, Katherine Irby, Joanna Jacobus, Vanessa L Jacoby, Pei-Ni Jone, David C Kaelber, Tyler J Kasmarcak, Matthew J Kluko, Jessica S Kosut, Angela R Laird, Jeremy Landeo-Gutierrez, Sean M Lang, Christine L Larson, Peter Paul C Lim, Krista M Lisdahl, Brian W Mccrindle, Russell J Mcculloh, Kimberly Mchugh, Alan L Mendelsohn, Torri D Metz, Julie Miller, Elizabeth C Mitchell, Lerraughn M Morgan, Eva M Müller-Oehring, Erica R Nahin, Michael C Neale, Manette Ness-Cochinwala, Sheila M Nolan, Carlos R Oliveira, Onyekachukwu Osakwe, Matthew E Oster, R Mark Payne, Michael A Portman, Hengameh Raissy, Isabelle G Randall, Suchitra Rao, Harrison T Reeder, Johana M Rosas, Mark W Russell, Arash A Sabati, Yamuna Sanil, Alice I Sato, Michael S Schechter, Rangaraj Selvarangan, S Kristen Sexson Tejtel, Divya Shakti, Kavita Sharma, Lindsay M Squeglia, Shubika Srivastava, Michelle D Stevenson, Jacqueline Szmuszkovicz, Maria M Talavera-Barber, Ronald J Teufel, Deepika Thacker, Felicia Trachtenberg, Mmekom M Udosen, Megan R Warner, Sara E Watson, Alan Werzberger, Jordan C Weyer, Marion J Wood, H Shonna Yin, William T Zempsky, Emily Zimmerman, Benard P Dreyer, Recover-Pediatric Consortium

Faculty, Staff and Students Publications

IMPORTANCE: The prevalence, pathophysiology, and long-term outcomes of COVID-19 (post-acute sequelae of SARS-CoV-2 [PASC] or "Long COVID") in children and young adults remain unknown. Studies must address the urgent need to define PASC, its mechanisms, and potential treatment targets in children and young adults.

OBSERVATIONS: We describe the protocol for the Pediatric Observational Cohort Study of the NIH's REsearching COVID to Enhance Recovery (RECOVER) Initiative. RECOVER-Pediatrics is an observational meta-cohort study of caregiver-child pairs (birth through 17 years) and young adults (18 through 25 years), recruited from more than 100 sites across the US. This report focuses on two of …

Researching Covid To Enhance Recovery (Recover) Pediatric Study Protocol: Rationale, Objectives And Design, Rachel S Gross, Deanna M. Barch, Andrew C. Heath, Et Al.

2020-Current year OA Pubs

IMPORTANCE: The prevalence, pathophysiology, and long-term outcomes of COVID-19 (post-acute sequelae of SARS-CoV-2 [PASC] or "Long COVID") in children and young adults remain unknown. Studies must address the urgent need to define PASC, its mechanisms, and potential treatment targets in children and young adults.

OBSERVATIONS: We describe the protocol for the Pediatric Observational Cohort Study of the NIH's REsearching COVID to Enhance Recovery (RECOVER) Initiative. RECOVER-Pediatrics is an observational meta-cohort study of caregiver-child pairs (birth through 17 years) and young adults (18 through 25 years), recruited from more than 100 sites across the US. This report focuses on two of …