bluuebunny/crossref_metadata_2025_split huggingface dataset:
386. Participant Reflections on Their Experiences Participating in Phase 1 and 2 Inpatient Vaccine Trials and Human Challenge Studies
Authors: Wunderlich Bettina , Chang Kathryn , Moulton Lawrence , Kass Nancy , Karron Ruth , Talaat Kawsar R 
Published: November 2023

Abstract

Background
Volunteers are critical for the success of clinical trials but there is still debate on the ethics surrounding recruitment and enrollment of healthy human subjects who are paid for their participation in such research. This study seeks to examine the experiences and perceptions of risks and benefits of participants in early-phase inpatient studies to gain greater insight into how they feel about participating.

Methods
An interviewer-administered survey was conducted with 152 healthy volunteers who participated in at least one Phase 1 or 2 inpatient vaccine or challenge clinical trial at the Johns Hopkins Center for Immunization Research, during the years of 2010-2020. Participant characteristics, study experiences, and perceived risks were analyzed. Poisson regression with robust variance was used to examine factors associated with perception of risk before and after participation.

Results
Most participants who completed the survey were male (62%) and Black or African American (78%). 53% attained at most a high school degree and 42% had an income below $18,500 a year. Compensation was the primary factor for joining a study for 68% of participants; 35% of them relied on clinical trials as a major part of their income. Nevertheless, 32% reported they declined to participate in at least one study and 63% reported that they ask about the side effects before joining a new study. Over 90% of participants agreed or strongly agreed that they enjoyed participating, wanted to participate, and were glad they joined the study. There was a significant reduction in the perceived risk of study participation after study completion compared to perceived risk before joining the study, where before the study 46% thought it was “Not at all risky” compared to 73% afterwards.

Conclusion
Most participants in our early-phase inpatient studies are males of lower income and compensation was the primary motivator for joining. However, side effects do factor in their decision whether to join. The majority of participants indicated that they were glad they joined the study. Despite the studies having risks and expected side effects, there was also a significant decline in perception of risks related to the study following participation, which implies participants feel safer than they anticipated feeling.

Disclosures
Lawrence Moulton, PhD, Pfizer Canada ULC: Employee Kawsar R. Talaat, MD, Intralytix: Advisor/Consultant|Merck: Advisor/Consultant|NIAID: DSMB|Pfizer: Grant/Research Support|Pfizer: Pfizer contract with institution|Sanofi: Grant/Research Support|Takeda: Advisor/Consultant
392. The Impact of Therapeutic Interventions on Post-Acute Sequelae of SARS-CoV-2 (PASC) in COVID-19 Survivors: A Retrospective Analysis
Authors: Calderon Andrea S , Englund Kristin 
Published: November 2023

Abstract

Background
Post-acute sequelae of SARS-CoV-2 (PASC) is a condition characterized by persistent and debilitating symptoms that continue more than 28 days beyond the acute phase of COVID-19. A significant proportion of individuals who have contracted COVID-19 have reported long-term symptoms consistent with PASC. Despite the growing number of reports on PASC, its exact pathophysiology remains unclear, and there are currently no effective treatments available. Although various therapeutic interventions have been developed and used to treat COVID-19 patients, the effectiveness of these interventions in preventing the development of PASC is not yet established. Therefore, there is a pressing need to identify potential long-term health impacts and the relationship between therapeutic interventions and the development of PASC in COVID-19 survivors.

Methods
A retrospective chart review was conducted at the reCOVer Clinic at Cleveland Clinic Foundation from March 2020 to November 2022. The study population consisted of patients diagnosed with PASC, who were matched with controls without PASC at a 1:1 ratio.

Results
We identified 57 patients that were deemed to have PASC in the study period. Multiple interventions that were given at the time of COVID-19 diagnosis were reviewed. Table 1 shows the characteristics of both patient groups. Our analysis did not find any significant differences in the baseline characteristics of patients who did and did not develop PASC, including hospital admission status, need for ICU, and need for intubation. Among those that received nirmatrelvir-ritonavir, tocilizumab, remdesivir and dexamethasone there were no statistical differences found in those that eventually developed PASC (p-values of 0.50, 0.74, 0.07 and 0.06, respectively).

Conclusion
The findings of our study suggest that treatment alone at the time of COVID-19 diagnosis is not protective against the development of PASC. Further studies are needed to identify other potential risk factors for PASC. Clinicians should consider future research focusing on identifying effective treatments for this debilitating condition.

Disclosures
All Authors: No reported disclosures
395. Remdesivir Stewardship Through Criteria for Use Implementation Across a Large System is Associated with Enhanced Outcomes and Efficiency
Authors: Daragjati Florian , Cosimi Reese , Ghosh Subhangi , Moreno Ana Cristina Perez , Miller Collin , Rice Erin , Fakih Mohamad G 
Published: November 2023

Abstract

Background
The National Institute of Health (NIH) COVID-19 Treatment Guidelines support use of remdesivir in hospitalized adults with mild-to-moderate COVID-19 infection for those at risk of progressing to severe COVID-19 and those who require oxygen supplementation, high-flow nasal cannula, or non-invasive ventilation. We implemented a standardized approach for the treatment of COVID-19 infection adopting the NIH criteria for use in a single system.

Methods
Patients ≥ 18 years old admitted with a diagnosis of COVID-19 infection from January 2021 to September 2022 in 94 hospitals from a single health system and 1012 peer hospitals from a large national database were included. Risk-adjusted outcomes in COVID-19 patients were compared, including mortality, readmissions, geometric mean length-of-stay (GMLOS), and mechanical ventilation days. We also compared remdesivir use in the COVID-19 population in the single health system and the large national database.

Results
85,874 and 789,660 COVID-19 patients were included from the single health system and large national database, respectively, during that time frame. Remdesivir use in COVID-19 patients was lower within the single system hospitals compared to external peer hospitals (33.6% vs 43.3% respectively; mean difference 9.7% (CI 8.5%-10.9%); p &lt; 0.001). Risk-adjusted mortality and GMLOS were also lower for the system compared to peer hospitals, while readmissions and mechanical ventilation use were not significantly different (Table).

Conclusion
The adoption of the NIH Criteria for remdesivir use in a single system was associated with lower COVID-19 mortality and lower geometric mean length of stay despite less remdesivir use compared to external peer hospitals. Our findings support optimizing the compliance with the NIH treatment guidelines.

Disclosures
Reese Cosimi, PharmD, Allergen: Advisor/Consultant
396. Clinical Characterization of Long COVID in Mexico
Authors: Del Carpio-Orantes Luis , García-Mendez Sergio , Sánchez-Díaz Jesús Salvador , Aguilar-Silva Andrés , Martínez-Rojas Manuel , Jiménez-Flores Oscar Rodrigo , Villalobos-López Luis Roberto , González-Arce América Alejandrina , González-Medel Karem Samantha , Domínguez-Cámara Rubén , Munguía-Sereno Alvaro Efrén , Zamora-Vázquez Violeta Rosalia , Vázquez-Manzano Quiahuitzin Elizabeth , Ortíz-Pérez Diego , Hernández-Martínez Semiramis Itzel , Hernández-Hernández Sara Nohemí , Solís-Sánchez Ishar , Fonseca-Pouchoulen Victor Alejandro , Montano-Montiel Laura Guadalupe , Reich-Sierra Reynaldo 
Published: November 2023

Abstract

Background
Long COVID is defined as the persistence of symptoms after 4 weeks of an acute picture. There is talk of 65 million people affected in the world. In Mexico there are no statistics or studies that explore this entity in the population.

Methods
A descriptive, cross-sectional, and prospective study was carried out using an online survey, in adults who wish to participate and who are living in Mexico from January to March 2023, whose main objective is to characterize patients who present symptoms of Long COVID

Results
336 participants with an average age of 41 years (range 18-79 years), the most affected gender is female (69%); Risk factors are Obesity 41%, Diabetes 16%, Hypertension 15.8%; 43.5% commented that they were healthy before COVID-19. Cases of acute COVID they have suffered, 42.3% comment that 2 previous infections, 29.5% had one and 28.3% 3 or more. 77% refer to mild COVID, 13% to severe COVID, and 10% both. Regarding vaccination, 45% have 3 or more vaccines, 36% 2 vaccines, 9% have one vaccine and 10% have not been vaccinated against COVID-19. The most prevalent symptoms are Neuropsychiatric 90%, Musculoskeletal 88%, Cardiovascular 82%, Gastrointestinal 78%, and Pulmonary 71%. The most frequent Neuropsychiatric symptoms: fatigue 76%, memory disorder 72%, anxiety 65%; Musculoskeletal symptoms are arthralgia 71.4%, myalgia 40%, arthritis 28%. Cardiovascular symptoms are palpitations 58%, tachycardia 38%, precordial pain 27%. Gastrointestinal symptoms are diarrhea 43%, abdominal pain 41%, Colitis 26%. Pulmonary symptoms are chronic cough 40%, persistent expectoration 29%, dyspnea 23%. Other symptoms are alopecia 53.3%, chronic dermatitis 38%, frequent infections after COVID-19 20%, menstrual disorders 17%, thyroid disease 12%, development of autoimmune diseases 9.5%, sexual dysfunction 9%, COVID tests persistently positive 6%, thrombotic events 3.6% (cerebral 0.9%, pulmonary thromboembolism 0.6%, myocardial infarction 0.3%), myocarditis 3.3%, chronic renal failure 2.4% and cancer 1.8%.

Conclusion
It is important to characterize this population since it has particularities that make it susceptible to this new entity and the creation of clinical guidelines in the country should be encouraged to begin limiting sequelae.

Disclosures
All Authors: No reported disclosures
398. Increased Risk of Severe COVID-19 Outcomes Across all Groups of Individuals with Hematological Malignancies, Solid Tumors, and Solid Organ Transplants Compared with the General Population: Initial Results from INFORM, a Retrospective Health Database Observational Study in England
Authors: McNulty Richard , Dube Sabada , Lu Yi , Graham Sophie , Arnetorp Sofie , Justo Nahila , Yokota Renata , Evans Kathryn , Venkatesan Sudhir , Yates Mark , Taylor Sylvia , Quint Jennifer , Evans Rachael A 
Published: November 2023

Abstract

Background
Despite COVID-19 vaccination, individuals who are immunocompromised due to underlying conditions, such as cancer and organ transplant, are at a greater risk of severe COVID-19 outcomes compared with the general population that is vaccinated. However, there are limited data quantifying this risk during the omicron-predominant period, particularly for important sub-groups that may have variable risk for severe COVID-19 outcomes. We report initial findings from the INFORM study describing the clinical burden and severe COVID-19 outcomes in patients with immunocompromised conditions (IC) in England, UK in 2022.

Methods
This retrospective cohort study utilized National Health Service database in England. The study period was from Jan 1–Dec 31, 2022 and the baseline period for assessment of patient characteristics, including IC, was from Jan 1, 2017–Dec 31, 2021. Definitions of IC sub-groups are provided in Table 1. Severe COVID-19 outcomes were defined as COVID-19–related hospitalization, COVID-19–related intensive care unit (ICU) admission, and/or COVID-related death.

Results
Of the 11,990,730 individuals in the general population sample aged ≥ 12 years, 468,745 (3.9%) were immunocompromised and accounted for approximately one-quarter of severe COVID-19–related outcomes (22% of hospitalizations, 28% of ICU admissions, and 23% of deaths; Table 2). The risk of severe COVID-19 outcomes was higher in well-recognized IC conditions (eg, solid organ transplants, hematological malignancies, and solid tumors) across all the sub-groups compared with the overall population (Table 2).

Conclusion
There is an increased burden in the prevalence of severe COVID-19 outcomes among all individuals with IC, highlighting the need for additional protection to target this population.

Disclosures
Richard McNulty, MD, AstraZeneca: Employee Sabada Dube, PhD, AstraZeneca: Employee Yi Lu, PhD, Evidera: Employee Sophie Graham, MSc, Evidera: Employee Sofie Arnetorp, MS, AstraZeneca: Employee Nahila Justo, PhD, MBA, Evidera: Employee|Karolinska Institute: Employee Renata Yokota, PhD, AstraZeneca: Employee Kathryn Evans, MPH, Evidera: Employee Sudhir Venkatesan, MPH, PhD, AstraZeneca: Employee Mark Yates, PhD, Evidera: Employee Sylvia Taylor, PhD, MPH, MBA, AstraZeneca: Stocks/Bonds Jennifer Quint, PhD, AstraZeneca: Grant/Research Support|Evidera: Grant/Research Support|GlaxoSmithKline: Grant/Research Support|Insmed: Grant/Research Support Rachael A. Evans, PhD FRCP, AstraZeneca: Advisor/Consultant|Boehringer: Advisor/Consultant|Evidera: Advisor/Consultant
407. Prevalence of Post-COVID Sequelae Amongst Fully Vaccinated and Unvaccinated US Hospitalized Veterans
Authors: Jeyapalina Sujee , Wei Guo , Stoddard Greg , Millier Aaron , Agarwal Jayant 
Published: November 2023

Abstract

Background
Post-Acute Sequelae of COVID-19, also known as long COVID, refers to a wide range of ongoing health symptoms and illnesses that persist for weeks or months after the acute phase of the COVID-19 illness has resolved. Based on the overwhelming reports of multiple health symptoms, the ICD-10 code U09.9 became effective on October 1, 2021, for coding ongoing symptoms or health problems related to COVID-19, a range of prevalence for long-COVID is reported. Thus, we hypothesized that among veterans who experienced a COVID-19 infection that required hospitalization, with follow-up beginning with the first hospitalization and assigning vaccination status on first hospital admission date, subsequent long COVID prevalence would be greater in the unvaccinated.

Methods
The deidentified veterans' data were accessed from the VA COVID-19 Shared Data Resources with local ethical approvals. The Veterans Affairs Informatics and Computing Infrastructure was used to extract patient health records for all U.S. veterans above the age of 18 who had tested positive for COVID-19. The primary outcome was the prevalence of reported U09.9 code after a single COVID-19 infection. The prevalence rates were calculated as the proportion of long-COVID within veterans who tested positive for COVID-19 disease between 10/01/2021 to 03/30/2023.

Results
In total, 468,620 veterans who were older than 18 reported being positive for COVID-19 within the studied period. Also, 68,125 veterans had reported multiple COVID-19 infections and were excluded from the study. Within this cohort, 15,772 veterans had the U09.09 code assigned, indicating a long-COVID prevalence rate of 3.93%. Although no significant difference was found between the prevalence of long-COVID between the vaccinated (3.98%) and unvaccinated (3.87%) veterans, post-hospitalization, vaccinated veterans had a much-reduced prevalence rate (3.50%) than that of the unvaccinated group (8.78%). This trend was mirrored by the requirement for mechanical ventilation.

Conclusion
Although the prevalence of long-COVID is 3.93% within the entire Veteran population, the prevalence of reported long-COVID was ∼three-fold greater in unvaccinated hospitalized veterans, with a ∼2.5-fold greater requirement for mechanical ventilation in the unvaccinated

Disclosures
All Authors: No reported disclosures
408. Clinical Spectrum of Pediatric Long COVID and Impact of COVID-19 Vaccines on the Clinical Course
Authors: Kamel Dina , Bender Jeffrey , Warburton David , Wood John C , Mohandas Sindhu 
Published: November 2023

Abstract

Background
Long COVID is a well-recognized, emerging health problem following COVID-19 infection. It presents with a wide range of ongoing, new, or returning symptoms following COVID-19 infection. Symptoms can last from weeks to months, significantly impacting patients’ quality of life. There is no precise definition for long COVID making it difficult to diagnose. Little is known about long COVID in children and the effect of COVID-19 vaccine on its course. This study aims to describe the most common symptoms in pediatric patients and to study the impact of vaccination on the course of long COVID.

Methods
A retrospective analysis of all children aged 0-21 years seen in the COVID Recovery Clinic at Children’s Hospital of Los Angeles from August 2021 to April 2023. Data were abstracted using a standardized tool and analyzed using SPSS 28.

Results
Overall, 107 patients were identified with long COVID. Of these, 51 (47.7%) were females with a median age of 14.1 years (IQR 11.1-15.9). Data regarding race and ethnicity were limited. The most commonly reported symptoms were fatigue (94.4%), headache (73.6%), exercise intolerance (57%), dizziness (49.5%), brain fog (41.1%), shortness of breath (31.8%), musculoskeletal pain (30.8%), chest pain and palpitations (29%). Symptoms developed immediately after COVID-19 infection in 56 (52.3%) of patients, within 1-4 weeks in 37 (34.7%), and after 4 weeks in 14 (13%) of them. At the time of presentation to the clinic, 57 (53.3%) were vaccinated against COVID-19, and 35 (61.4%) of them received the vaccine after the onset of long COVID symptoms. Of those 35 patients, 51.4% reported no change in symptoms after vaccine administration, 42.9% reported symptom improvement and 5.7% had progression of symptoms.
Figure (1)
Figure (2)

Conclusion
Long COVID is a growing well-recognized problem in children after COVID-19 infection. In our large cohort of pediatric patients, we identified fatigue and headache as the predominant presenting symptoms. COVID-19 vaccine led to symptomatic improvement in a proportion of patients. Longer prospective follow-up is needed to help better understand the impact of long COVID on children. COVID-19 vaccines should be further investigated in a systematic fashion as a possible therapeutic intervention in children with long COVID.

Disclosures
All Authors: No reported disclosures
409. Unvaccinated Adolescents Bear the Majority of Disease Burden of Severe COVID-19 Among Those Admitted to the Intensive Care Unit (ICU)
Authors: Kaushik Ashlesha , Thieman Corey , Gupta Sandeep 
Published: November 2023

Abstract

Background
COVID-19 vaccination is one of the most important public health tools to prevent severe COVID-19.

Methods
COVID-19 vaccine (Pfizer-BioNTech) first received the U.S. Food and Drug Administration (FDA) Emergency use authorization (EUA) for individuals 16 years of age and older on 12/11/2020 and for 12-15 years of age on 5/10/2021. We evaluated clinical and epidemiologic characteristics of critically ill adolescents with COVID-19 admitted to the intensive care unit (ICU) at our tertiary-care centers in Northwestern Iowa (encompassing Sioux City and Sergeant Bluff locations) during the 1-year post-vaccination approval period from June 1, 2021- May 31, 2022. Adolescence was defined as age-group 12-21 years per WHO definition.

Results
Twenty-one adolescents were admitted to the ICU with a median age of 16 years (IQR 12-20 years) and male: female ratio of 1:1.3. The majority (77%) were admitted with COVID-19 related pneumonia and 10 developed hypoxemic respiratory failure; 19 of 21 (90%) adolescent patients admitted to the ICU during this period were unvaccinated and all adolescents developing respiratory failure (10/10, 100%) were unvaccinated. Majority of patients with respiratory failure (70%) required mechanical ventilation (MV). Seventy % of patients with respiratory failure were obese (BMI of &gt;30); 40% of patients had two or more pre-existing comorbidities; those with BMI &gt;40 were 4.3 times more likely to develop respiratory failure (p&lt; 0.0001). Inflammatory markers were 5-20 times higher among patients with respiratory failure (p&lt; 0.05); 60% of those with respiratory failure developed complications including ARDS, acute renal injury and cerebral anoxic encephalopathy. All with respiratory failure required parenteral steroids. Mean duration of ICU stay was significantly longer for patients with respiratory failure [14.6 (±1.7) days versus 7.5 (± 2.6) days, p&lt; 0.0001)]. None of the patients died. After hospital discharge, 30% patients reported post COVID-19 fatigue at 3-month follow up.

Conclusion
Our results showed that all of the critically ill adolescent patients with COVID-19 associated hypoxemic respiratory failure were unvaccinated and majority developed complications. These results further emphasize importance of COVID-19 vaccination efforts for adolescents.

Disclosures
All Authors: No reported disclosures
410. Acinetobacter baumannii Infections During COVID: Molecular Epidemiology and Outcomes at a Tertiary Hospital in Dallas
Authors: Khazi-Syed Afeefah F , Pybus Christine A , Clark Andrew E , Kim Jiwoong , Zhan Xiaowei , Desai Dhara , Barth Jackson , Greenberg David E 
Published: November 2023

Abstract

Background
Acinetobacter baumannii (AB) is a significant human pathogen that is frequently antibiotic resistant and has been associated with post-COVID-19 infections.

Methods
In this study, we performed whole-genome sequencing on AB isolates collected at an academic medical center in Dallas, TX between January 2020 and June 2021. We extracted clinical and laboratory data and analyzed both outcomes and molecular epidemiology of AB isolates in patients with and without COVID-19.

Results
Nineteen isolates collected from 17 AB-infected patients were included in this study. Most isolates were cultured from the respiratory tract (58%), followed by urine (16%), blood (10.5%), wound (10.5%), and catheter tips (5%). 4/17 patients were COVID-19 positive. The average Charlson Comorbidity Index at admission was lower for patients with COVID-19 (2.75) compared to counterparts (4.46). Using Fisher’s exact test, no statistical significance was observed in hospital events: ICU Admission (0.08), Ventilation (1.0), and Sepsis (0.23). The mortality rate during admission was 50% for COVID-19 patients and 23% for patients without COVID-19 (Odds Ratio: 3.33, p-value: 0.54, 95% CI: [0.32, 34.83]). All 19 isolates were carbapenem-resistant (CRAB) and multi-drug resistant (MDR) per definitions established by Magiarkos et al. 67% of isolates from COVID-19 patients were extensively-drug resistant (XDR) compared to 33% of isolates from non-COVID-19 patients. MIC data for cefiderocol was available for 9/19 isolates. Values ranged from 0.5 – 16 μM with 4/9 isolates being &lt; 4 μM. Meropenem MIC values for all isolates were ≥ 64 μM. Many isolates contained at least one carbapenemase: OXA-72 (15/19), OXA-23 (3/19), OXA-95 (3/19), OXA-24 (1/19). MLST analysis revealed ST2 as the most common in all patients (15/19), followed by ST499 (3/19) and ST406 (1/19).

Conclusion
COVID-19 patients infected with AB trended towards a significant difference in mortality compared to AB patients without documented COVID-19 during the same period. All AB isolates were CRAB, and isolates from COVID-19 patients were more likely to be XDR.

Disclosures
David E. Greenberg, MD, University of Texas Southwestern Medical Center: Dr. Greenberg has numerous patents on PPMOs