bluuebunny/crossref_metadata_2025_split huggingface dataset:
414. Sex differences in clinical presentation and outcomes amongst hospitalized patients with COVID-19 in Singapore
Authors: Koh Matthew C Y , Ngiam Jinghao Nicholas , Chhabra Srishti , Goh Wilson , Sim Meng Ying , Chew Nicholas W S , Sia Ching-Hui , Cross Gail , Tambyah Paul 
Published: November 2023

Abstract

Background
Sex differences in clinical presentation and outcomes in patients with coronavirus disease 2019 (COVID-19) remain to be clearly defined. We sought to evaluate sex differences in the presentation and outcomes of COVID-19 in our Asian context.

Methods
We retrospectively examined 1781 consecutive patients hospitalised from 2020 to 2021, with polymerase chain reaction confirmed SARS-CoV-2 infection. Patients were divided into males and females. Baseline clinical characteristics, laboratory findings as well as clinical outcomes were compared. Adverse composite clinical outcomes were defined as requiring supplemental oxygenation, intensive care or mortality.

Results
Of the 1781 patients studied, 351 (19.7%) were female. The male predominance in our cohort were due to large outbreaks of COVID-19 in dormitory workers early in the pandemic. Female patients had more medical comorbidities, and were slightly older (46.4±18.3 vs 41.1±13.4 years, p&lt; 0.001). They had a lower serum ferritin level (174.6±336.7 vs 216.7±284.7 µg/L, p=0.027), but no significant difference in the serum C-reactive protein (16.9±29.1 vs 14.4±29.8 mg/dL, p=0.187). Females were more likely to require supplemental oxygenation (7.1% vs 2.7%, p=0.025) and intensive care (4.8% vs 2.7%, p=0.034), but we did not demonstrate a difference in mortality (0.9% vs 0.7%, p=0.728). On multivariable analysis, female gender remained independently associated with adverse composite outcomes (adjusted OR 1.89, 95%CI 1.17-3.04) after adjusted for dormitory exposure and prior vaccination against COVID-19.
Comparing COVID-19 clinical presentation and outcomes in females versus males amongst hospitalised patients from 2020 to 2021
Multivariable analysis showing female gender independently associated with increased odds of adverse clinical outcomes in COVID-19 illness

Conclusion
Female sex may be associated with adverse clinical outcomes in hospitalised patients with COVID-19. Further study is needed to elucidate and investigate the pathophysiological mechanisms behind this observation.

Disclosures
All Authors: No reported disclosures
417. Impact of Post-acute Sequelae of COVID-19 (PASC) on Healthcare Workers (HCW) in NYC Public Hospital in the South Bronx
Authors: Lim Chee Yao , Gutierrez Jorge , Garcia Alberto Romero , Patel Pinal , Johan Kenneth , Duran Israel , Evans Jeffery , Riordan Anna , Singh Inderpreet , Shariff Masood A , Ashraf Rabia , Kasubhai Moiz , Shabarek Nehad , Dimitrov Vihren , Menon Vidya 
Published: November 2023

Abstract

Background
COVID-19 infection is known to cause long-term sequelae with impact on multiple systems. HCW are at increased risk for COVID-19 exposure and infection. The aim of our study was to assess the burden of PASC among HCW in NYC public hospital which was at the epicenter of the pandemic.

Methods
In this single-center, cross-sectional study, HCW with previous COVID-19 infection were administered an anonymous voluntary survey to evaluate PASC, and its impact on their quality of life (QoL) and mental health. We used CDC COVID-19 variant data tracker to identify predominant variants during the infection. Average number of symptoms/signs, severity, and changes in quality of life were analyzed using JASP.
Inclusion Process of Study Population

Results
Out of the 236 subjects, 144 (61%) had PASC, with 78% having 2 or more symptoms/signs with fatigue being the most common (40%) [Fig 2]. Women had significantly more symptoms than men (2.37 vs 1.26, p=0.005). The mean number of symptoms was comparable among age groups. Average numbers of symptoms were significantly higher among patients who were involved in direct patient care vs indirect patient care. Patients who had reinfection had more symptoms than patients without (2.52 vs 1.76, p=0.02). Among the variants of concern, wild and alpha variants were associated with a higher number of symptoms (p=0.01). Cognitive dysfunction and mental illness (depression/anxiety) were observed to be significantly worsened following COVID-19 infection. PASC adversely affected activities of daily living and disrupted lifestyle.
Breakdown of symptoms/signs according to frequency
Subject Baseline Characteristics

Conclusion
Significant burden of PASC was observed in our healthcare community. The short- and long-term consequences of PASC for HCW could severely affect healthcare services and it is crucial to conduct research and allocate resources to mitigate and overcome these issues.

Disclosures
All Authors: No reported disclosures
429. Risk of COVID-19 Related Deaths for SARS-CoV-2 Omicron (B.1.1.529) Compared With Delta (B.1.617.2): A Retrospective Cohort Study
Authors: Paulson Shon , Raju Jomel 
Published: November 2023

Abstract

Background
The study aimed to assess the risk of covid-19 death after infection with omicron BA.1 compared with the delta (B.1.617.2) variant of the SARS-CoV-2 virus in India.

Methods
The retrospective cohort study is conducted in the state of Kerala, India by retrieving data from the COVID-19 database of the Directorate of Health Services (DHS), Government of Kerala. The main outcome measure was covid-19 death as identified from death certification records. The exposure of interest was the SARS-CoV-2 variant identified PCR positive tests taken in the community sampling and analyzed by the state-approved laboratories. Cause-specific Cox proportional hazard regression models (censoring non-covid-19 deaths) were adjusted for sex, age, vaccination status, previous infection, calendar time, ethnicity, and comorbidities. Interactions between variants and sex, age, vaccination status, and comorbidities were also investigated.

Results
A total of 1035143 people aged 18-100 years who tested positive for SARS-CoV-2 under the surveillance program for COVID-19 and had an infection identified as omicron BA.1 or delta variants of SARS-CoV-2 were included in the study. The risk of covid-19 death was 66% lower (95% confidence interval 54% to 75%) for omicron BA.1 compared with delta after adjusting for a wide range of potential confounders. The reduction in the risk of covid-19 death for omicron compared with delta was more pronounced in people aged 18-59 years (number of deaths: delta=46, omicron=11; hazard ratio 0.14, 95% confidence interval 0.07 to 0.27) than in those aged ≥70 years (number of deaths: delta=113, omicron=135; hazard ratio 0.44, 95% confidence interval 0.32 to 0.61, P&lt; 0.0001). No evidence of a difference in risk was found between the variant and the number of comorbidities.

Conclusion
The results support earlier studies showing a reduction in the severity of infection with omicron BA.1 compared with a delta in terms of hospital admission. This study extends the research to also show a reduction in the risk of covid-19 death for the omicron variant compared with the delta variant.

Disclosures
All Authors: No reported disclosures
438. Predicting Severe and Critical COVID-19 in Fully Vaccinated Individuals: a Single Center Retrospective Cohort Study
Authors: Rivera Charles Kevin L , Carascal Mark B , Cristina Perez Ma , Destura Raul V , Henson Karl Evans R 
Published: November 2023

Abstract

Background
The ability to predict severe/critical Coronavirus Diseases 2019 (COVID-19) infection in fully vaccinated individuals is an incompletely defined area of research and a scoring tool is lacking. Most scoring systems are validated against unvaccinated patients making it less clinically applicable in today’s global landscape. Our study validated an existing clinical prediction tool using data from vaccinated individuals, and created a new model that could provide improved prediction accuracy.

Methods
Consecutive adult patients fully vaccinated against COVID-19 and admitted to a tertiary hospital from March 2021 to August 2022 for a breakthrough infection were enrolled. Clinical characteristics, type and number of vaccine doses, and RT-PCR cycle-threshold (CT) values were collected. Primary outcome of interest was development of severe/critical COVID-19. An existing severe/critical COVID-19 prediction tool was validated using study data as a comparator prediction tool. Multivariable logistic regression analysis was performed to create a simpler scoring system to predict COVID-19 severity.

Results
Among 390 adults with COVID-19, 106 (27%) received at least 1 booster dose and 54 (14%) progressed to severe/critical disease. The existing prediction tool had a sensitivity (Sn) of 98.1%, specificity (Sp) of 7.5% and area under the receiver-operator curve (AUROC) of 0.58. Multivariable logistic regression showed that age &gt;75y (OR 2.15; 95% CI 1.04 - 4.47), diabetes mellitus (OR 1.98, 95% CI 1.07-3.67), CT value &lt; 20 (OR 3.48; 95% CI: 1.78 - 6.79), and non-receipt of a booster dose (OR 0.26; 95% CI: 0.11 - 0.64) were independent risk factors for developing severe/critical COVID-19. The final model showed a Sn of 65%, Sp of 68% and AUROC of 0.71.

Conclusion
A simplified scoring tool using 4 variables may help predict progression to severe/critical COVID-19 in fully vaccinated individuals. Although the tool has modest Sn and Sp, it can be used to help triage patients and guide initial therapy. Validation of this tool in larger studies is recommended.

Disclosures
All Authors: No reported disclosures
443. Albumin is a Reliable and Accurate Biomarker for Assessing Clinical Course of Multisystem Inflammatory Syndrome in Children
Authors: Sharon Bazak , Nath Conor 
Published: November 2023

Abstract

Background
In Spring 2020, Multisystem Inflammatory Syndrome in Children (MIS-C) emerged as a life-threatening pediatric complication to COVID-19. It is a complex and novel disease often requiring high levels of intensive care. As case definitions and guidelines are still being developed, it is imperative to identify biomarkers that can accurately assess its clinical course in hospitalized children.

Methods
Utilizing the electronic medical records we retrieved the charts of children who were hospitalized at the University of Minnesota Masonic children’s Hospital for treatment of MIS-C. We reviewed their clinical course including daily monitoring of various inflammatory markers and analyzed the trends of albumin and CRP.

Results
Between May 2020 and January 2022, thirty-six children diagnosed with MIS-C were admitted to the University of Minnesota Masonic children’s Hospital [Figure 1]. Complications included myocarditis, coronary aneurysm, coagulopathy, acute kidney injury, and shock. Seventeen children required PICU stay. All patients had elevated CRP on presentation, and values typically started to decline within 24-48 hours [Figure 2]. However, hypoalbuminemia continued to worsen for 4-5 days after admission, especially for patients requiring intensive care [Figure 3]. Both markers gradually improved for the entire cohort, reflecting the positive outcome our patients demonstrated.

Conclusion
Our study highlights the reliability of CRP and albumin as biomarkers for assessing MIS-C patients. While CRP values showed a wide range and high variability throughout the course of illness, albumin appeared to be more accurate, particularly in critically ill children. We recommend regular monitoring of albumin as an inflammatory marker and suggest frequent follow-up for children with systemic inflammatory disease.

Disclosures
All Authors: No reported disclosures
448. Real World Evaluation of Clinical Outcomes for Short-Duration Remdesivir Therapy in Hospitalized Patients with Mild-Moderate COVID-19
Authors: Williams Kelsey N , Gauthier Timothy P , Baker Stacey W , Cua Jefferson 
Published: November 2023

Abstract

Background
The optimal duration of remdesivir for hospitalized patients with COVID-19 remains unclear. National Institute of Health (NIH) Guidelines recommend a standard duration of 5 days or until hospital discharge. This study aims to compare the outcomes of hospitalized patients who received ≤ 4 days of remdesivir compared to those who received ≥ 5 days.

Methods
This retrospective study was conducted at a 900-bed community hospital from Jan 1 to Dec 31, 2022. Adult patients were included if ≥ 1 dose of remdesivir was received during hospitalization. Patients were excluded if hypoxic at baseline (oxygen saturation ≤ 94% or on supplemental oxygen). The primary outcome was COVID-19-related hospital readmission within 30 days. Secondary outcomes included hospital length of stay, 30-day mortality, and estimated healthcare cost avoidance (total drug cost and days of hospital admission avoided in the ≤ 4 day group).

Results
1,253 unique patients were screened for inclusion. 772 were hypoxic at baseline, leaving 481 patients for analyses: 67 patients (14%) received ≥ 5 days and 406 (86%) received ≤ 4 days. Table 1 shows demographic data and baseline characteristics. COVID-19 related re-admissions within 30 days occurred in 2 (3%) patients in ≥ 5 day group and 6 (1%) in ≤ 4 day group (p=0.6). Median length of stay was 6 days in ≥ 5 day group and 4 days in ≤ 4 day group (p=&lt; 0.0001). All-cause mortality within 30 days was 0 in the ≥ 5 day group and 5 (1%) in the ≤ 4 day group (p=0.61). No deaths were COVID-19 related. Hypoxia was observed during treatment in 25 (37%) in the ≥ 5 day group and 131 (32%) in the ≤ 4 day group (p=0.41); no difference in outcomes was observed between patients who did and did not develop hypoxia. Estimated cost savings in the ≤ 4 day group was $1,635,312.88 total ($426,312.88 in drug expenditure, $1,209,000.00 for 465 days of avoided admission), or $4,027.86 per patient. Outcomes data is available in Table 2.

Conclusion
Remdesivir for a full 5 days is not warranted in all at-risk hospitalized patients with mild-moderate COVID-19. Shorter remdesivir courses were not found to be associated with worse outcomes and had substantially reduced healthcare costs.

Disclosures
Timothy P. Gauthier, PharmD, BCPS, BCIDP, Ferring: Advisor/Consultant|Firstline: Advisor/Consultant|Firstline: Writing|GSK: Advisor/Consultant|LearnAntibiotics.com & IDstewardship.com: Owner|Melinta: Advisor/Consultant|Pattern Biosciences: Advisor/Consultant|Pfizer: Advisor/Consultant
480. Duration of Infectious Virus Shedding by SARS-CoV-2 Omicron Variant among Immunocompromised Patients
Authors: KAMEGAI K O H E I , Iwamoto Noriko , Itoh Naoya , Ishikane Masahiro , Asai Yusuke , Akazawa Nana , Fuwa Noriko , Takasaki Jin , Hojo Masayuki , Hangaishi Akira , Togano Tomiteru , Teruya Katsuji , Kanno Takayuki , Takahashi Kenichiro , Miyamoto Sho , Hirata Yuichiro , Saito Tomoya , Katano Harutaka , Suzuki Tadaki , Ohmagari Norio 
Published: November 2023

Abstract

Background
Immunocompromised patients with coronavirus disease (COVID-19) shed SARS-CoV-2 RNA longer than usual, but the duration of viral shedding and criteria for nosocomial de-isolation in these patients remains unclear.

Methods
A prospective cohort study was performed at two tertiary medical centers in Japan during the Omicron epidemic waves from July 8, 2022, to January 30, 2023. Nasopharyngeal swab samples were serially collected from immunocompromised COVID-19 patients. We included populations with either hematological malignancies, solid tumors, autoimmune diseases, or human immunodeficiency virus infection. Patients were classified as severely or moderately immunocompromised based on the national COVID-19 guidelines in Japan. The relationship among patients' characteristics, immune status, quantitative reverse transcription PCR (qRT-PCR), and duration of infectious virus shedding between the two groups was assessed using Mann-Whitney U and Fisher's exact tests.

Results
Among 41 patients with 163 samples, nine patients and 47 samples were severely immunocompromised, and 32 patients and 116 samples were moderately immunocompromised. The median ages of the two groups were 70 (IQR: 56-71) and 70.5 (IQR: 60.75-75) years, respectively.
In the severely immunocompromised group, 87.2% of the samples (41/47) were PCR-positive, with a median Cq value of 26.1 (IQR: 20.5-30.2), and 36.2% (17/47) were culture-positive. In the moderately immunocompromised group, 75.0% of the samples (87/116) were PCR-positive, with a median Cq value of 21.9 (IQR: 18.4-28.6), and 38.8% (45/116) were culture-positive (Table 1).
Of the 62 culture-positive samples, five (8.1%) were culture-positive from day 20 onwards, all from severely immunocompromised patients (P = 0.001). In moderately immunocompromised patients, none were culture-positive on day 12 or later (Figure 1).

Conclusion
In COVID-19 patients, particularly those severely immunocompromised, the duration of viral shedding should be closely monitored. Further research is needed to establish a safe period for in-hospital de-isolation of immunocompromised patients.

Disclosures
All Authors: No reported disclosures
484. Clinical Description of SARS-CoV-2 Infection in Patients with Primary Antibody Deficiency Who Received Tixagevimab/Cilgavimab Prophylaxis
Authors: Lim Sung Min , Shin Je Hee , Baek Jee Yeon , Lee Ji Young , Kang Ji-Man , Ahn Jong Gyun 
Published: November 2023

Abstract

Background
Patients with primary antibody deficiency are known to be associated with a higher risk of SARS-CoV-2 infection, complications, and mortality. Tixagevimab/Cilgavimab prophylaxis has shown efficacy in reducing hospitalization and mortality. We aim to describe the clinical characteristics and outcomes of COVID-19 cases in primary antibody deficiency patients receiving tixagevimab/cilgavimab prophylaxis in South Korea.

Methods
This is a descriptive analysis of COVID-19 infection in primary antibody deficiency patients at Severance Children's Hospital. From September 2021 to February 2023, we retrospectively collected data, including demographic characteristics, comorbidities, tixagevimab/cilgavimab prophylaxis status, SARS-CoV-2 vaccination, COVID-19 infection, clinical presentation, COVID-19 treatment, oxygen supplement, hospitalization, and clinical outcome.

Results
Thirteen patients (12 with X-linked agammaglobulinemia and 1 with common variable immunodeficiency) were enrolled in this study. Among them, 10 received tixagevimab/cilgavimab prophylaxis, while the remaining 3 did not. Three patients developed breakthrough infection after receiving prophylaxis. Patient 1 (29 years old, male) completed a SARS-CoV-2 booster mRNA vaccination, had no prior COVID-19 infection, and developed COVID-19 infection 104 days after prophylaxis. Patient 2 (33 years old, male) received 2 doses of mRNA vaccine, had no prior infection history, and developed COVID-19 infection 3 days after prophylaxis. Patient 3 (13 years old, male) had no history of previous vaccination, had an infection history before receiving prophylaxis, and developed COVID-19 infection 19 days after prophylaxis. All 3 patients experienced mild symptoms and did not require oxygen therapy or hospitalization. Of the 7 patients who were not infected with COVID-19 after prophylaxis, 6 had a history of COVID-19 infection, and all of them received SARS-CoV-2 mRNA vaccine. The follow-up period after prophylaxis ranged from 198 to 241 days.Table 1.Clinical description of the hypogammaglobulinemia patients who were diagnosed with COVID-19 with or without tixagevimab-cilgavimab prophylaxis

Conclusion
In this study, we observed that 3 out of 10 primary antibody deficiency patients who received tixagevimab/cilgavimab prophylaxis were infected COVID-19 but did not require hospitalization or oxygen supplementation.

Disclosures
All Authors: No reported disclosures
510. Real-world Effectiveness of Sotrovimab for COVID-19: Evidence from United States (US) Administrative Claims Data
Authors: Bell Christopher F , Lokhandwala Tasneem , Gibbons Daniel C , Drysdale Myriam , Wang Jane , Lloyd Emily 
Published: November 2023

Abstract

Background
This study compared outcomes among COVID-19 patients (pts) treated with the monoclonal antibody (mAb) sotrovimab matched to untreated pts.

Methods
Administrative claims (Komodo Health) were used to identify pts (≥ 12 years) diagnosed with COVID-19 (ICD-10: U0.7.1) in an ambulatory setting in the US (26 May 2021–5 April 2022). The sotrovimab cohort included pts meeting sotrovimab’s Emergency Use Authorization (EUA) criteria and receiving sotrovimab ≤ 10 days from diagnosis (index date = day of infusion). The untreated cohort included pts with no evidence of early/prophylaxis mAb or antiviral treatments (index date imputed based on the time distribution between diagnosis and sotrovimab infusion for their matched counterpart from the sotrovimab cohort). Pts were required to be continuously enrolled for ≥ 12 months pre-index and ≥ 29 days post-index (excluding death). Exact matching and propensity-score matching (EM/PSM) methods were used to construct 1:2 matched cohorts of sotrovimab-treated and untreated patients (EM; age [≤ 5 years], diagnosis date [≤ 14 days], state: PSM; gender, payor, region, Quan-Charlson score, EUA criteria, index date, baseline healthcare utilization). Outcomes evaluated in the 29-day post-index period were all-cause hospitalization, all-cause hospitalization and/or mortality, all-cause mortality, intensive care unit (ICU) admission, and maximum level of respiratory support.

Results
A total of 34,160 sotrovimab pts were matched to 68,320 untreated pts (characteristics well balanced: 54 years of age, approximately 40% male, 42% had commercial payor, and approximately 50% indexed in January 2022). The 29-day hospitalization and/or mortality rates were 4.0% (n=1,380 / 34,160) and 5.2% (n=3,566 / 68,320) in the sotrovimab and untreated cohorts, respectively (p &lt; 0.0001). Patients in the sotrovimab cohort had statistically significantly lower rates of all-cause hospitalization, all-cause mortality, ICU admission, and respiratory support as compared with patients in the untreated cohort (Table).
*Obtained from conditional logistic regression models (binary outcomes). All models adjusted for malignancy. ECMO, extracorporeal membrane oxygenation; ICU, intensive care unit

Conclusion
Sotrovimab demonstrated effectiveness in preventing severe outcomes (hospitalization, mortality and respiratory support) as compared with untreated pts during the period in which Delta and early Omicron variants were predominant.

Disclosures
Christopher F. Bell, MS, GSK: Employee|GSK: Stocks/Bonds Tasneem Lokhandwala, PhD, GSK: Funding to conduct study|Vir Biotechnology, Inc: Funding to conduct study Daniel C. Gibbons, PhD, GSK: Employee|GSK: Stocks/Bonds Myriam Drysdale, PhD, GSK: Employee|GSK: Stocks/Bonds Jane Wang, MS, GSK: Funding to conduct study|Vir Biotechnology, Inc: Funding to conduct study Emily Lloyd, MSc, GSK: Employee|GSK: Stocks/Bonds