COVID-19 Commons^™

Transitioning From An In-Person Intervention To Augmented Text Messaging During Covid-19 In Mexican Americans With Prediabetes: The Starr County Diabetes Prevention Randomized Clinical Trial, Sharon A Brown, Mary A Winter, Heather A Becker, Alexandra A García, Mary M Velasquez, Hirofumi Tanaka, William B Perkison, Eric L Brown, David Aguilar, Craig L Hanis

Faculty, Staff and Student Publications

PURPOSE: The purpose of the study was to explore the feasibility of using commonly available technology, such as text messaging, for diabetes prevention in rural Mexican American communities during COVID-19.

METHODS: Participants were selected from a diabetes prevention study funded by the National Institutes of Health that, prior to COVID-19, involved in-person group intervention sessions. Participants were predominantly female adults born in Mexico and Spanish-speaking. A subsample (n = 140) was divided into 3 cohorts: (1) 50 who completed the initial in-person intervention prior to the COVID-19 research pause, (2) 60 who needed additional support sessions to complete the intervention …

Maintaining Program Fidelity In A Changing World: National Implementation Of A School-Based Hiv Prevention Program, Elizabeth Schieber, Lynette Deveaux, Lesley Cotrell, Xiaoming Li, Stephenie C Lemon, Arlene S Ash, Karen Macdonell, Samiran Ghosh, Maxwell Poitier, Glenda Rolle, Sylvie Naar, Bo Wang

Faculty, Staff and Student Publications

Large-scale, evidence-based interventions face challenges to program fidelity of implementation. We developed implementation strategies to support teachers implementing an evidence-based HIV prevention program in schools, Focus on Youth in The Caribbean (FOYC) and Caribbean Informed Parents and Children Together (CImPACT) in The Bahamas. We examined the effects of these implementation strategies on teachers' implementation in the subsequent year after the initial implementation during the COVID-19 pandemic. Data were collected from 79 Grade 6 teachers in 24 government elementary schools. Teachers completed training workshops and a pre-implementation questionnaire to record their characteristics and perceptions that might affect their program fidelity. School …

Abatacept Pharmacokinetics And Exposure Response In Patients Hospitalized With Covid-19, Stephen J Balevic, Daniel K Benjamin, William G Powderly, P Brian Smith, Daniel Gonzalez, Matthew W Mccarthy, Linda K Shaw, Christopher J Lindsell, Sam Bozzette, Daphne Williams, Benjamin P Linas, John Blamoun, Heta Javeri, Christoph P Hornik

Faculty, Staff and Student Publications

IMPORTANCE: The pharmacokinetics of abatacept and the association between abatacept exposure and outcomes in patients with severe COVID-19 are unknown.

OBJECTIVE: To characterize abatacept pharmacokinetics, relate drug exposure with clinical outcomes, and evaluate the need for dosage adjustments.

DESIGN, SETTING, AND PARTICIPANTS: This study is a secondary analysis of data from the ACTIV-1 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) Immune Modulator (IM) randomized clinical trial conducted between October 16, 2020, and December 31, 2021. The trial included hospitalized adults who received abatacept in addition to standard of care for treatment of COVID-19 pneumonia. Data analysis was performed between September 2022 …

Inpatient Costs Of Treating Patients With Covid-19, Kandice A Kapinos, Richard M Peters, Robert E Murphy, Samuel F Hohmann, Ankita Podichetty, Raymond S Greenberg

Faculty, Staff and Student Publications

IMPORTANCE: With more than 6.2 million hospitalizations due to COVID-19 in the US, recognition of the average hospital costs to provide inpatient care during the pandemic is necessary to understanding the national medical resource use and improving public health readiness and related policies.

OBJECTIVE: To examine the mean cost to provide inpatient care to treat COVID-19 and how it varied through the pandemic waves and by important sociodemographic patient characteristics.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used inpatient-level data from March 1, 2020, to March 31, 2022, extracted from a repository of clinical, administrative, and financial information covering 97% …

Baseline Characteristics Of Sars-Cov-2 Vaccine Non-Responders In A Large Population-Based Sample, Ashraf Yaseen, Stacia M Desantis, Rachit Sabharwal, Yashar Talebi, Michael D Swartz, Shiming Zhang, Luis Leon Novelo, Cesar L Pinzon-Gomez, Sarah E Messiah, Melissa Valerio-Shewmaker, Harold W Kohl, Jessica Ross, David Lakey, Jennifer A Shuford, Stephen J Pont, Eric Boerwinkle

Faculty, Staff and Student Publications

INTRODUCTION: Studies indicate that individuals with chronic conditions and specific baseline characteristics may not mount a robust humoral antibody response to SARS-CoV-2 vaccines. In this paper, we used data from the Texas Coronavirus Antibody REsponse Survey (Texas CARES), a longitudinal state-wide seroprevalence program that has enrolled more than 90,000 participants, to evaluate the role of chronic diseases as the potential risk factors of non-response to SARS-CoV-2 vaccines in a large epidemiologic cohort.

METHODS: A participant needed to complete an online survey and a blood draw to test for SARS-CoV-2 circulating plasma antibodies at four-time points spaced at least three months …

Exploring The Relationship Between Vaccine Hesitancy And Mothers’ Perspectives On Covid-19 Vaccines For Children Ages 5–11 Years During The Omicron Predominant Period 2021–2022: A Qualitative Study, Tiffany A Suragh, David Adzrago, Marlyn A Allicock, Paul G Yeh, Paula Cuccaro

Faculty, Staff and Student Publications

Background: The United States Food and Drug Administration authorized COVID-19 vaccines for children ages 5-11 years in October 2021 during the Omicron predominant period. Parental vaccine hesitancy was prevalent during this time, resulting in low childhood COVID-19 vaccine uptake. Most studies exploring factors influencing parental vaccine hesitancy have focused on racial and ethnic minorities and lower socioeconomic populations; however, there is little knowledge of the drive drivers of vaccine hesitancy among White parents with higher education and socioeconomic statuses.

Methods: We conducted semi-structured interviews with a sample of 15 White mothers of children ages 5-11 years in Atlanta, GA, between …

Hpv Vaccination In Africa In The Covid-19 Era: A Cross-Sectional Survey Of Healthcare Providers' Knowledge, Training, And Recommendation Practices, Joel Fokom Domgue, Issimouha Dille, Sharon Kapambwe, Robert Yu, Freddy Gnangnon, Lameck Chinula, Gad Murenzi, Nomonde Mbatani, Mala Pande, Fatoumata Sidibe, Joseph Kamgno, Bangaly Traore, Hicham El Fazazi, Mamadou Diop, Pierre-Marie Tebeu, Mohenou Isidore Diomande, Fabrice Lecuru, Isaac Adewole, Marie Plante, Partha Basu, Jean-Marie Dangou, Sanjay Shete

Faculty, Staff and Student Publications

INTRODUCTION: Although the burden of cervical cancer in Africa is highest, HPV vaccination coverage remains alarmingly low in this region. Providers' knowledge and recommendation are key drivers of HPV vaccination uptake. Yet, evidence about providers' knowledge and recommendation practices about the HPV vaccine against a backdrop of emerging vaccine hesitancy fueled by the COVID-19 pandemic is lacking in Africa.

METHODS: A cross-sectional study was conducted in 2021-2022 among healthcare providers involved in cervical cancer prevention activities in Africa. They were invited to report prior training, the availability of the HPV vaccine in their practice, whether they recommended the HPV vaccine, …

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 …

Correlations Between Mental Health, Physical Activity, And Body Composition In American College Students After The Covid-19 Pandemic Lockdown, Luis Torres, Manuela C Caciula, Alin S Tomoiaga, Carmen Gugu-Gramatopol

Faculty, Staff and Student Publications

Restrictions associated with the COVID-19 pandemic had forced American college students to significantly reduce their daily energy expenditure and increase their sedentary behaviors, thus presumably increasing mental health symptoms, decreasing physical activity levels, and enhancing the promotion of unhealthy eating habits. This study aimed to explore the correlations between mental health symptoms, physical activity levels, and body composition in college students in the years following the pandemic, focusing on the lingering effects of lockdown measures. American college students completed pre-existing, well-validated surveys for both mental health (Hospital Anxiety and Depression Scale) and physical activity (International Physical Activity Questionnaire—Long Form). Body …

Ramipril For The Treatment Of Covid-19: Ramic, A Randomized, Double-Blind, Placebo-Controlled Clinical Trial, Daniel Q Huang, Veeral Ajmera, Christian Tomaszewski, Andrew Lafree, Ricki Bettencourt, Wesley K Thompson, Davey M Smith, Atul Malhotra, Ravindra L Mehta, Vaishal Tolia, Jeffrey Yin, Paul A Insel, Stone Leachman, Jinho Jung, Summer Collier, Lisa Richards, Kristin Woods, Maral Amangurbanova, Archana Bhatt, Xinlian Zhang, Oana M Penciu, Stuart Zarich, Tamrat Retta, Michelle S Harkins, J Pedro Teixeira, Brian Chinnock, Netanya S Utay, Jordan E Lake, Rohit Loomba

Faculty, Staff and Student Publications

Introduction: Retrospective studies report that angiotensin-converting enzyme inhibitors (ACEIs) may reduce the severity of COVID-19, but prospective data on de novo treatment with ACEIs are limited. The RAMIC trial was a randomized, multicenter, placebo-controlled, double-blind, allocation-concealed clinical trial to examine the efficacy of de novo ramipril versus placebo for the treatment of COVID-19.

Methods: Eligible participants were aged 18 years and older with a confirmed diagnosis of SARS-CoV-2 infection, recruited from urgent care clinics, emergency departments, and hospital inpatient wards at eight sites in the USA. Participants were randomly assigned to daily ramipril 2.5 mg or placebo orally in a …

Dynamics Of Inflammatory Responses After Sars-Cov-2 Infection By Vaccination Status In The Usa: A Prospective Cohort Study, Xianming Zhu, Kelly A Gebo, Alison G Abraham, Feben Habtehyimer, Eshan U Patel, Oliver Laeyendecker, Thomas J Gniadek, Reinaldo E Fernandez, Owen R Baker, Malathi Ram, Edward R Cachay, Judith S Currier, Yuriko Fukuta, Jonathan M Gerber, Sonya L Heath, Barry Meisenberg, Moises A Huaman, Adam C Levine, Aarthi Shenoy, Shweta Anjan, Janis E Blair, Daniel Cruser, Donald N Forthal, Laura L Hammitt, Seble Kassaye, Giselle S Mosnaim, Bela Patel, James H Paxton, Jay S Raval, Catherine G Sutcliffe, Matthew Abinante, Patrick Broderick, Valerie Cluzet, Marie Elena Cordisco, Benjamin Greenblatt, Joann Petrini, William Rausch, David Shade, Karen Lane, Amy L Gawad, Sabra L Klein, Andrew Pekosz, Shmuel Shoham, Arturo Casadevall, Evan M Bloch, Daniel Hanley, David J Sullivan, Aaron A R Tobian

Faculty, Staff and Student Publications

BACKGROUND: Cytokines and chemokines play a critical role in the response to infection and vaccination. We aimed to assess the longitudinal association of COVID-19 vaccination with cytokine and chemokine concentrations and trajectories among people with SARS-CoV-2 infection.

METHODS: In this longitudinal, prospective cohort study, blood samples were used from participants enrolled in a multi-centre randomised trial assessing the efficacy of convalescent plasma therapy for ambulatory COVID-19. The trial was conducted in 23 outpatient sites in the USA. In this study, participants (aged ≥18 years) were restricted to those with COVID-19 before vaccination or with breakthrough infections who had blood samples …

Intravenous Aviptadil And Remdesivir For Treatment Of Covid-19-Associated Hypoxaemic Respiratory Failure In The Usa (Tesico): A Randomised, Placebo-Controlled Trial, Samuel M Brown, Christina E Barkauskas, Birgit Grund, Shweta Sharma, Andrew N Phillips, Lindsay Leither, Ithan D Peltan, Michael Lanspa, Daniel L Gilstrap, Ahmad Mourad, Kathleen Lane, Jeremy R Beitler, Alexis L Serra, Ivan Garcia, Eyad Almasri, Mohamed Fayed, Kinsley Hubel, Estelle S Harris, Elizabeth A Middleton, Macy A G Barrios, Kusum S Mathews, Neha N Goel, Samuel Acquah, Jarrod Mosier, Cameron Hypes, Elizabeth Salvagio Campbell, Akram Khan, Catherine L Hough, Jennifer G Wilson, Joseph E Levitt, Abhijit Duggal, Siddharth Dugar, Andrew J Goodwin, Charles Terry, Peter Chen, Sam Torbati, Nithya Iyer, Uriel S Sandkovsky, Nicholas J Johnson, Bryce R H Robinson, Michael A Matthay, Neil R Aggarwal, Ivor S Douglas, Jonathan D Casey, Manuel Hache-Marliere, J Georges Youssef, William Nkemdirim, Brad Leshnower, Omar Awan, Sonal Pannu, Darragh Shane O'Mahony, Prasad Manian, J W Awori Hayanga, Glenn W Wortmann, Bruno M Tomazini, Robert F Miller, Jens-Ulrik Jensen, Daniel D Murray, Nina A Bickell, Jigna Zatakia, Sarah Burris, Elizabeth S Higgs, Ven Natarajan, Robin L Dewar, Adam Schechner, Nayon Kang, Alejandro Arenas-Pinto, Fleur Hudson, Adit A Ginde, Wesley H Self, Angela J Rogers, Cathryn F Oldmixon, Haley Morin, Adriana Sanchez, Amy C Weintrob, Alexandre Biasi Cavalcanti, Anne Davis-Karim, Nicole Engen, Eileen Denning, B Taylor Thompson, Annetine C Gelijns, Virginia Kan, Victoria J Davey, Jens D Lundgren, Abdel G Babiker, James D Neaton, H Clifford Lane

Faculty, Staff and Student Publications

BACKGROUND: There is a clinical need for therapeutics for COVID-19 patients with acute hypoxemic respiratory failure whose 60-day mortality remains at 30-50%. Aviptadil, a lung-protective neuropeptide, and remdesivir, a nucleotide prodrug of an adenosine analog, were compared with placebo among patients with COVID-19 acute hypoxaemic respiratory failure.

METHODS: TESICO was a randomised trial of aviptadil and remdesivir versus placebo at 28 sites in the USA. Hospitalised adult patients were eligible for the study if they had acute hypoxaemic respiratory failure due to confirmed SARS-CoV-2 infection and were within 4 days of the onset of respiratory failure. Participants could be randomly …

Cancer Patients' Preferences And Perceptions Of Advantages And Disadvantages Of Telehealth Visits During The Covid-19 Pandemic, Deepika Kumar, Nancy Gordon, Constanza Zamani, Tammy Sheehan, Ernesto Martin, Olga Egorova, Jessica Payne, Tatjana Kolevska, Elad Neeman, Raymond Liu

Faculty, Staff and Student Publications

PURPOSE: We aimed to ascertain oncology patients' perceptions of telehealth versus in-person (IP) visits for different types of clinical encounters.

METHODS: We surveyed adults undergoing cancer treatment at Kaiser Permanente Northern California infusion centers between November 2021 and May 2022 using a self-administered questionnaire. Patients were asked about visit modality preferences (video, phone, and IP) for six types of clinical discussions, overall advantages and disadvantages of telehealth (video or phone) versus IP modalities, and barriers to video visit use.

RESULTS: The 839 patients who completed surveys in English were 63% female; median age 63 years; 64% White; and 73% college-educated …

Postoperative Respiratory Complications In Sars-Cov-2 Positive Pediatric Patients Across 20 United States Hospitals: A Cohort Study, Audra J Reiter, Martha-Conley E Ingram, Mehul V Raval, Elisa Garcia, Madelyn Hill, Arturo Aranda, Nicole M Chandler, Raquel Gonzalez, Kristen Born, Shale Mack, Abdulraouf Lamoshi, Aaron M Lipskar, Xiao-Yue Han, Elizabeth Fialkowski, Brianna Spencer, Afif N Kulaylat, Amrene Barde, Ami N Shah, Maeva Adoumie, Erica Gross, Steven C Mehl, Monica E Lopez, Valerie Polcz, Moiz M Mustafa, Jeffrey W Gander, Travis M Sullivan, Jason P Sulkowski, Owais Ghani, Eunice Y Huang, David Rothstein, E Peter Muenks, Shawn D St Peter, Jason C Fisher, Dina Levy-Lambert, Allison Reichl, Romeo C Ignacio, Bethany J Slater, Kuojen Tsao, Loren Berman

Faculty, Staff and Student Publications

INTRODUCTION: Data examining rates of postoperative complications among SARS-CoV-2 positive children are limited. The purpose of this study was to evaluate the impact of symptomatic and asymptomatic SARS-CoV-2 positive status on postoperative respiratory outcomes for children.

METHODS: This retrospective cohort study included SARS-CoV-2 positive pediatric patients across 20 hospitals who underwent general anesthesia from March to October 2020. The primary outcome was frequency of postoperative respiratory complications, including: high-flow nasal cannula/non invasive ventilation, reintubation, pneumonia, Extracorporeal Membrane Oxygenation (ECMO), and 30-day respiratory-related readmissions or emergency department (ED) visits. Univariate analyses were used to evaluate associations between patient and procedure characteristics …

Abatacept, Cenicriviroc, Or Infliximab For Treatment Of Adults Hospitalized With Covid-19 Pneumonia: A Randomized Clinical Trial, Jane A O'Halloran, Emily R Ko, Kevin J Anstrom, Eyal Kedar, Matthew W Mccarthy, Reynold A Panettieri, Martin Maillo, Patricia Segura Nunez, Anne M Lachiewicz, Cynthia Gonzalez, P Brian Smith, Sabina Mendivil-Tuchia De Tai, Akram Khan, Alfredo J Mena Lora, Matthias Salathe, Gerardo Capo, Daniel Rodríguez Gonzalez, Thomas F Patterson, Christopher Palma, Horacio Ariza, Maria Patelli Lima, John Blamoun, Esteban C Nannini, Eduardo Sprinz, Analia Mykietiuk, Radica Alicic, Adriana M Rauseo, Cameron R Wolfe, Britta Witting, Jennifer P Wang, Luis Parra-Rodriguez, Tatyana Der, Kate Willsey, Jun Wen, Adam Silverstein, Sean M O'Brien, Hussein R Al-Khalidi, Michael A Maldonado, Richard Melsheimer, William G Ferguson, Steven E Mcnulty, Pearl Zakroysky, Susan Halabi, Daniel K Benjamin, Sandra Butler, Jane C Atkinson, Stacey J Adam, Soju Chang, Lisa Lavange, Michael Proschan, Samuel A Bozzette, William G Powderly, Activ-1 Im Study Group Members

Faculty, Staff and Student Publications

IMPORTANCE: Immune dysregulation contributes to poorer outcomes in COVID-19.

OBJECTIVE: To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia.

DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-masked, placebo-controlled clinical trial using a master protocol to investigate immunomodulators added to standard care for treatment of participants hospitalized with COVID-19 pneumonia. The results of 3 substudies are reported from 95 hospitals at 85 clinical research sites in the US and Latin America. Hospitalized patients 18 years or older with confirmed SARS-CoV-2 infection within 14 days and evidence of pulmonary involvement underwent randomization between October 2020 and …

Abatacept, Cenicriviroc, Or Infliximab For Treatment Of Adults Hospitalized With Covid-19 Pneumonia: A Randomized Clinical Trial, Jane A O'Halloran, Emily R Ko, Kevin J Anstrom, Eyal Kedar, Matthew W Mccarthy, Reynold A Panettieri, Martin Maillo, Patricia Segura Nunez, Anne M Lachiewicz, Cynthia Gonzalez, P Brian Smith, Sabina Mendivil-Tuchia De Tai, Akram Khan, Alfredo J Mena Lora, Matthias Salathe, Gerardo Capo, Daniel Rodríguez Gonzalez, Thomas F Patterson, Christopher Palma, Horacio Ariza, Maria Patelli Lima, John Blamoun, Esteban C Nannini, Eduardo Sprinz, Analia Mykietiuk, Radica Alicic, Adriana M Rauseo, Cameron R Wolfe, Britta Witting, Jennifer P Wang, Luis Parra-Rodriguez, Tatyana Der, Kate Willsey, Jun Wen, Adam Silverstein, Sean M O'Brien, Hussein R Al-Khalidi, Michael A Maldonado, Richard Melsheimer, William G Ferguson, Steven E Mcnulty, Pearl Zakroysky, Susan Halabi, Daniel K Benjamin, Sandra Butler, Jane C Atkinson, Stacey J Adam, Soju Chang, Lisa Lavange, Michael Proschan, Samuel A Bozzette, William G Powderly

Faculty, Staff and Student Publications

IMPORTANCE: Immune dysregulation contributes to poorer outcomes in COVID-19.

OBJECTIVE: To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia.

DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-masked, placebo-controlled clinical trial using a master protocol to investigate immunomodulators added to standard care for treatment of participants hospitalized with COVID-19 pneumonia. The results of 3 substudies are reported from 95 hospitals at 85 clinical research sites in the US and Latin America. Hospitalized patients 18 years or older with confirmed SARS-CoV-2 infection within 14 days and evidence of pulmonary involvement underwent randomization between October 2020 and …

Psychosocial Impacts Of The Covid-19 Pandemic On Women With Spinal Cord Injury, Heather B Taylor, Rosemary B Hughes, Diana Gonzalez, Muna Bhattarai, Susan Robinson-Whelen

Faculty, Staff and Student Publications

This study represents the first known research addressing the impact of the COVID-19 pandemic on women with spinal cord injury (SCI) in the United States. Women in this population face unique barriers that put them at elevated risk for compromised quality of life, risk that was magnified by physical and social restrictions imposed during the pandemic. This qualitative study examined the perceptions of women with SCI and the effect of the pandemic on their lives. The predominantly White and relatively well-educated sample of 105 women with traumatic SCI was diverse in age, injury characteristics, and geographic representation. Recruited across the …

Trends And Seasonality Of Emergency Department Visits And Hospitalizations For Suicidality Among Children And Adolescents In The Us From 2016 To 2021, Youngran Kim, Trudy Millard Krause, Scott D Lane

Faculty, Staff and Student Publications

IMPORTANCE: The detection of seasonal patterns in suicidality should be of interest to clinicians and US public health officials, as intervention efforts can benefit by targeting periods of heightened risk.

OBJECTIVES: to examine recent trends in suicidality rates, quantify the seasonality in suicidality, and demonstrate the disrupted seasonality patterns during the spring 2020 COVID-19-related school closures among US children and adolescents.

DESIGN, SETTING, AND PARTICIPANTS: This population-based, descriptive cross-sectional study used administrative claims data from Optum's deidentifed Clinformatics Data Mart Database. Participants included children aged 10 to 12 years and adolescents aged 13 to 18 years who were commercially insured …

Development Of A Definition Of Postacute Sequelae Of Sars-Cov-2 Infection, Tanayott Thaweethai, Sarah E Jolley, Elizabeth W Karlson, Emily B Levitan, Bruce Levy, Grace A Mccomsey, Lisa Mccorkell, Girish N Nadkarni, Sairam Parthasarathy, Upinder Singh, Tiffany A Walker, Caitlin A Selvaggi, Daniel J Shinnick, Carolin C M Schulte, Rachel Atchley-Challenner, George A Alba, Radica Alicic, Natasha Altman, Khamal Anglin, Urania Argueta, Hassan Ashktorab, Gaston Baslet, Ingrid V Bassett, Lucinda Bateman, Brahmchetna Bedi, Shamik Bhattacharyya, Marie-Abele Bind, Andra L Blomkalns, Hector Bonilla, Hassan Brim, Patricia A Bush, Mario Castro, James Chan, Alexander W Charney, Peter Chen, Lori B Chibnik, Helen Y Chu, Rebecca G Clifton, Maged M Costantine, Sushma K Cribbs, Sylvia I Davila Nieves, Steven G Deeks, Alexandria Duven, Ivette F Emery, Nathan Erdmann, Kristine M Erlandson, Kacey C Ernst, Rachael Farah-Abraham, Cheryl E Farner, Elen M Feuerriegel, Judes Fleurimont, Vivian Fonseca, Nicholas Franko, Vivian Gainer, Jennifer C Gander, Edward M Gardner, Linda N Geng, Kelly S Gibson, Minjoung Go, Jason D Goldman, Halle Grebe, Frank L Greenway, Mounira Habli, John Hafner, Jenny E Han, Keith A Hanson, James Heath, Carla Hernandez, Rachel Hess, Sally L Hodder, Matthew K Hoffman, Susan E Hoover, Beatrice Huang, Brenna L Hughes, Prasanna Jagannathan, Janice John, Michael R Jordan, Stuart D Katz, Elizabeth S Kaufman, John D Kelly, Sara W Kelly, Megan M Kemp, John P Kirwan, Jonathan D Klein, Kenneth S Knox, Jerry A Krishnan, Andre Kumar, Adeyinka O Laiyemo, Allison A Lambert, Margaret Lanca, Joyce K Lee-Iannotti, Brian P Logarbo, Michele T Longo, Carlos A Luciano, Karen Lutrick, Jason H Maley, Gail Mallett, Jai G Marathe, Vincent Marconi, Gailen D Marshall, Christopher F Martin, Yuri Matusov, Alem Mehari, Hector Mendez-Figueroa, Robin Mermelstein, Torri D Metz, Richard Morse, Jarrod Mosier, Christian Mouchati, Janet Mullington, Shawn N Murphy, Robert B Neuman, Janko Z Nikolich, Ighovwerha Ofotokun, Elizabeth Ojemakinde, Anna Palatnik, Kristy Palomares, Tanyalak Parimon, Samuel Parry, Jan E Patterson, Thomas F Patterson, Rachel E Patzer, Michael J Peluso, Priscilla Pemu, Christian M Pettker, Beth A Plunkett, Kristen Pogreba-Brown, Athena Poppas, John G Quigley, Uma Reddy, Rebecca Reece, Harrison Reeder, W B Reeves, Eric M Reiman, Franz Rischard, Jonathan Rosand, Dwight J Rouse, Adam Ruff, George Saade, Grecio J Sandoval, Jorge L Santana, Shannon M Schlater, Frank C Sciurba, Fitzgerald Shepherd, Zaki A Sherif, Hyagriv Simhan, Nora G Singer, Daniel W Skupski, Amber Sowles, Jeffrey A Sparks, Fatima I Sukhera, Barbara S Taylor, Larissa Teunis, Robert J Thomas, John M Thorp, Paul Thuluvath, Amberly Ticotsky, Alan T Tita, Katherine R Tuttle, Alfredo E Urdaneta, Daisy Valdivieso, Timothy M Vanwagoner, Andrew Vasey, Monica Verduzco-Gutierrez, Zachary S Wallace, Honorine D Ward, David E Warren, Steven J Weiner, Shelley Welch, Sidney W Whiteheart, Zanthia Wiley, Juan P Wisnivesky, Lynn M Yee, Sokratis Zisis, Leora I Horwitz, Andrea S Foulkes

Faculty, Staff and Student Publications

IMPORTANCE: SARS-CoV-2 infection is associated with persistent, relapsing, or new symptoms or other health effects occurring after acute infection, termed postacute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID. Characterizing PASC requires analysis of prospectively and uniformly collected data from diverse uninfected and infected individuals.

OBJECTIVE: To develop a definition of PASC using self-reported symptoms and describe PASC frequencies across cohorts, vaccination status, and number of infections.

DESIGN, SETTING, AND PARTICIPANTS: Prospective observational cohort study of adults with and without SARS-CoV-2 infection at 85 enrolling sites (hospitals, health centers, community organizations) located in 33 states plus Washington, DC, …

Higher Dose Corticosteroids In Patients Admitted To Hospital With Covid-19 Who Are Hypoxic But Not Requiring Ventilatory Support (Recovery): A Randomised, Controlled, Open-Label, Platform Trial, Recovery Collaborative Group

Faculty, Staff and Student Publications

BACKGROUND: Low-dose corticosteroids have been shown to reduce mortality for patients with COVID-19 requiring oxygen or ventilatory support (non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation). We evaluated the use of a higher dose of corticosteroids in this patient group.

METHODS: This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing multiple possible treatments in patients hospitalised for COVID-19. Eligible and consenting adult patients with clinical evidence of hypoxia (ie, receiving oxygen or with oxygen saturation

FINDINGS: Between May 25, 2021, and May 13, 2022, 1272 patients with COVID-19 and hypoxia receiving no oxygen …

Higher Dose Corticosteroids In Patients Admitted To Hospital With Covid-19 Who Are Hypoxic But Not Requiring Ventilatory Support (Recovery): A Randomised, Controlled, Open-Label, Platform Trial, Recovery Collaborative Group

Faculty, Staff and Student Publications

BACKGROUND: Low-dose corticosteroids have been shown to reduce mortality for patients with COVID-19 requiring oxygen or ventilatory support (non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation). We evaluated the use of a higher dose of corticosteroids in this patient group.

METHODS: This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing multiple possible treatments in patients hospitalised for COVID-19. Eligible and consenting adult patients with clinical evidence of hypoxia (ie, receiving oxygen or with oxygen saturation

FINDINGS: Between May 25, 2021, and May 13, 2022, 1272 patients with COVID-19 and hypoxia receiving no oxygen …

Outcomes Following Extracorporeal Membrane Oxygenation For Severe Covid-19 In Pregnancy Or Post Partum, John J Byrne, Amir A Shamshirsaz, Alison G Cahill, Mark A Turrentine, Angela R Seasely, Joe Eid, Caroline E Rouse, Michael Richley, Nandini Raghuraman, Mariam Naqvi, Yasser Y El-Sayed, Martina L Badell, Cece Cheng, James Liu, Emily H Adhikari, Soha S Patel, Erika R O'Neil, Patrick S Ramsey

Faculty, Staff and Student Publications

IMPORTANCE: Existing reports of pregnant patients with COVID-19 disease who require extracorporeal membrane oxygenation (ECMO) are limited, with variable outcomes noted for the maternal-fetal dyad.

OBJECTIVE: To examine maternal and perinatal outcomes associated with ECMO used for COVID-19 with respiratory failure during pregnancy.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective multicenter cohort study examined pregnant and postpartum patients who required ECMO for COVID-19 respiratory failure at 25 hospitals across the US. Eligible patients included individuals who received care at one of the study sites, were diagnosed with SARS-CoV-2 infection during pregnancy or up to 6 weeks post partum by positive nucleic …

Effect Of Angiotensin-Converting Enzyme Inhibitor And Angiotensin Receptor Blocker Initiation On Organ Support-Free Days In Patients Hospitalized With Covid-19: A Randomized Clinical Trial, Patrick R Lawler, Lennie P G Derde, Frank L Van De Veerdonk, Bryan J Mcverry, David T Huang, Lindsay R Berry, Elizabeth Lorenzi, Roland Van Kimmenade, Frank Gommans, Muthiah Vaduganathan, David E Leaf, Rebecca M Baron, Edy Y Kim, Claudia Frankfurter, Slava Epelman, Yvonne Kwan, Richard Grieve, Stephen O'Neill, Zia Sadique, Michael Puskarich, John C Marshall, Alisa M Higgins, Paul R Mouncey, Kathryn M Rowan, Farah Al-Beidh, Djillali Annane, Yaseen M Arabi, Carly Au, Abi Beane, Wilma Van Bentum-Puijk, Marc J M Bonten, Charlotte A Bradbury, Frank M Brunkhorst, Aidan Burrell, Adrian Buzgau, Meredith Buxton, Maurizio Cecconi, Allen C Cheng, Matthew Cove, Michelle A Detry, Lise J Estcourt, Justin Ezekowitz, Mark Fitzgerald, David Gattas, Lucas C Godoy, Herman Goossens, Rashan Haniffa, David A Harrison, Thomas Hills, Christopher M Horvat, Nao Ichihara, Francois Lamontagne, Kelsey M Linstrum, Daniel F Mcauley, Anna Mcglothlin, Shay P Mcguinness, Zoe Mcquilten, Srinivas Murthy, Alistair D Nichol, David R J Owen, Rachael L Parke, Jane C Parker, Katrina M Pollock, Luis Felipe Reyes, Hiroki Saito, Marlene S Santos, Christina T Saunders, Christopher W Seymour, Manu Shankar-Hari, Vanessa Singh, Alexis F Turgeon, Anne M Turner, Ryan Zarychanski, Cameron Green, Roger J Lewis, Derek C Angus, Scott Berry, Anthony C Gordon, Colin J Mcarthur, Steve A Webb

Faculty, Staff and Student Publications

IMPORTANCE: Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19.

OBJECTIVE: To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19.

DESIGN, SETTING, AND PARTICIPANTS: In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non-critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022).

INTERVENTIONS: Patients were randomized to receive open-label initiation of an ACE inhibitor …

Effect Of Thromboprophylaxis On Clinical Outcomes After Covid-19 Hospitalization, Tracy Y Wang, Abdus S Wahed, Alison Morris, Lisa Baumann Kreuziger, John G Quigley, Gervasio A Lamas, Alexandra J Weissman, Jose Lopez-Sendon, M Margaret Knudson, Deborah M Siegal, Raj S Kasthuri, Andrew J Alexander, Lana Wahid, Bassel Atassi, Peter J Miller, Janice W Lawson, Bela Patel, Jerry A Krishnan, Nancy L Shapiro, Deborah E Martin, Andrei L Kindzelski, Eric S Leifer, Jungnam Joo, Lingyun Lyu, Annie Pennella, Brendan M Everett, Mark W Geraci, Kevin J Anstrom, Thomas L Ortel, Activ-4c Study Group

Faculty, Staff and Student Publications

BACKGROUND: Patients hospitalized with COVID-19 have an increased incidence of thromboembolism. The role of extended thromboprophylaxis after hospital discharge is unclear.

OBJECTIVE: To determine whether anticoagulation is superior to placebo in reducing death and thromboembolic complications among patients discharged after COVID-19 hospitalization.

DESIGN: Prospective, randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT04650087).

SETTING: Done during 2021 to 2022 among 127 U.S. hospitals.

PARTICIPANTS: Adults aged 18 years or older hospitalized with COVID-19 for 48 hours or more and ready for discharge, excluding those with a requirement for, or contraindication to, anticoagulation.

INTERVENTION: 2.5 mg of apixaban versus placebo twice daily for …

Identification Of Bradycardia Following Remdesivir Administration Through The Us Food And Drug Administration American College Of Medical Toxicology Covid-19 Toxic Pharmacovigilance Project, Jason M Devgun, Rongmei Zhang, Jeffrey Brent, Paul Wax, Keith Burkhart, Alison Meyn, Sharan Campleman, Stephanie Abston, Kim Aldy

Faculty, Staff and Student Publications

IMPORTANCE: The rapid spread and mortality associated with COVID-19 emphasized a need for surveillance system development to identify adverse events (AEs) to emerging therapeutics. Bradycardia is a remdesivir infusion-associated AE listed in the US Food and Drug Administration-approved prescribing information.

OBJECTIVE: To evaluate the magnitude and duration of bradycardic events following remdesivir administration.

DESIGN, SETTING, AND PARTICIPANTS: A multicenter cohort study of patients with recorded heart rate less than 60 beats per minute within 24 hours after administration of a remdesivir dose was conducted between November 23, 2020, and October 31, 2021. Participants included patients hospitalized with COVID-19 at 15 …

Assessment Of Symptom, Disability, And Financial Trajectories In Patients Hospitalized For Covid-19 At 6 Months, Andrew J Admon, Theodore J Iwashyna, Lee A Kamphuis, Stephanie J Gundel, Sarina K Sahetya, Ithan D Peltan, Steven Y Chang, Jin H Han, Kelly C Vranas, Kirby P Mayer, Aluko A Hope, Sarah E Jolley, Ellen Caldwell, Max L Monahan, Katrina Hauschildt, Samuel M Brown, Neil R Aggarwal, B Taylor Thompson, Catherine L Hough

Faculty, Staff and Student Publications

IMPORTANCE: Individuals who survived COVID-19 often report persistent symptoms, disabilities, and financial consequences. However, national longitudinal estimates of symptom burden remain limited.

OBJECTIVE: To measure the incidence and changes over time in symptoms, disability, and financial status after COVID-19-related hospitalization.

DESIGN, SETTING, AND PARTICIPANTS: A national US multicenter prospective cohort study with 1-, 3-, and 6-month postdischarge visits was conducted at 44 sites participating in the National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network's Biology and Longitudinal Epidemiology: COVID-19 Observational (BLUE CORAL) study. Participants included hospitalized English- or Spanish-speaking adults without severe prehospitalization …

Researching Covid To Enhance Recovery (Recover) Pregnancy Study: Rationale, Objectives And Design, Torri D Metz, Rebecca G Clifton, Richard Gallagher, Rachel S Gross, Leora I Horwitz, Vanessa L Jacoby, Susanne P Martin-Herz, Myriam Peralta-Carcelen, Harrison T Reeder, Carmen J Beamon, James Chan, A Ann Chang, Maged M Costantine, Megan L Fitzgerald, Andrea S Foulkes, Kelly S Gibson, Nick Güthe, Mounira Habli, David N Hackney, Matthew K Hoffman, M Camille Hoffman, Brenna L Hughes, Stuart D Katz, Victoria Laleau, Gail Mallett, Hector Mendez-Figueroa, Vanessa Monzon, Anna Palatnik, Kristy T S Palomares, Samuel Parry, Christian M Pettker, Beth A Plunkett, Athena Poppas, Uma M Reddy, Dwight J Rouse, George R Saade, Grecio J Sandoval, Shannon M Schlater, Frank C Sciurba, Hyagriv N Simhan, Daniel W Skupski, Amber Sowles, Tanayott Thaweethai, Gelise L Thomas, John M Thorp, Alan T Tita, Steven J Weiner, Samantha Weigand, Lynn M Yee, Valerie J Flaherman

Faculty, Staff and Student Publications

IMPORTANCE: Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads.

METHODS: RECOVER-Pregnancy cohort is a …

Post-Acute Sequelae Of Covid-19 And Longitudinal Antibody Levels In A Community-Based Cohort, Noa Kopplin, Angie Garcia, Annika Reczek, Kate Wilkinson, Sruthi Yekkaluri, Caitlin C Murphy, Jasmin Tiro, Alagar R Muthukumar, Andrew Masica, Amit G Singal

Faculty, Staff and Student Publications

BACKGROUND: Coronavirus disease 2019 (COVID-19) infection invokes variable immune responses and poses a risk of post-acute sequelae SARS-CoV-2 infection (PASC) symptoms; however, most data on natural history are derived from patients with severe infection. Further data are needed among patients with mild infection, who comprise most cases.

METHODS: The Dallas Fort-Worth (DFW) COVID-19 Prevalence Study included 21,597 community-dwelling adults (ages 18-89) who underwent COVID-19 PCR and anti-nucleocapsid antibody testing between July 2020 and March 2021. We invited participants with positive COVID-19 results (cases) and a subset with negative results (controls), matched on age, sex, race/ethnicity, and ZIP code, to complete …

Pregnancy-Related Covid Worry, Depressive Symptom Severity, And Mediation Through Sleep Disturbance In A Low-Income, Primarily Latinx Population In California’S Central Valley, Jennifer N Felder, Patience A Afulani, Kimberly Coleman-Phox, Serwaa S Omowale, Charles E Mcculloch, Lauren Lessard, Miriam Kuppermann

Faculty, Staff and Student Publications

Purpose: This study (1) assessed the psychometric properties of a pregnancy-related COVID worry scale, (2) explored variations in pregnancy-related COVID worry over the course of the pandemic, and (3) examined associations between pregnancy-related COVID worry and depressive symptom severity, and evaluated sleep disturbance as a mediator.

Methods: Data were drawn from an ongoing randomized trial comparing the effectiveness of two enhanced forms of prenatal care. The current analysis includes baseline pre-randomization data collected from participants who enrolled November 2020-November 2021 (n = 201). Participants were pregnant individuals with low income and primarily Latinx.

Results: Our 7-item scale was valid and …

Depression And Insomnia Among Healthcare Professionals During Covid-19 Pandemic In Ethiopia: A Systematic Review And Meta-Analysis, Aragaw Asfaw Hasen, Abubeker Alebachew Seid, Ahmed Adem Mohammed

Faculty, Staff and Student Publications

INTRODUCTION: Healthcare professionals play a great role in the struggle against COVID-19. They are highly susceptible to COVID-19 due to their responsibilities. This susceptibility directly affects their mental health status. Comprehensive evidence on prevalence of depression and insomnia during this pandemic is vital. Thus, this study aims to provide the pooled prevalence of depression and insomnia, and their associated factors during the COVID-19 pandemic.

MATERIALS AND METHODS: This systematic review and meta-analysis follow the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Studies were searched from PubMed, Cochrane Library, CrossRef, African Journals Online and Google Scholar databases from …