bluuebunny/crossref_metadata_2025_split huggingface dataset:
440. Steroid Use and Elevated Rates of Coinfections and Mortality in Mild-COVID-19 Patients
Authors: Rebellon-Sanchez David E , Llanos-Torres Julio , Álvarez-Ortega Carolina , Guzman-Gonzales Tania M , Rodríguez Sarita , Rosso Fernando 
Published: November 2023

Abstract

Background
Systemic corticosteroids are used to treat patients with COVID-19. Since the findings of the RECOVERY trial, steroids have been broadly used in critical patients. However, their use in patients with mild disease was unclear and may even be harmful. In the hard times of the pandemic in the absence of widely available vaccines or antivirals agents, hospital overcrowding, patients had to be referred to home care and steroids could be overused. The aim of this study was to explore the relationship between the use of corticosteroids, secondary infections and overall mortality in adults with COVID-19

Methods
A prospective observational study was performed in a university hospital in Cali, Colombia. Severity was assessed with NEWS score 2. The study included patients at various levels of severity, including patients admitted to the emergency department, inpatients, and those admitted to the intensive care unit

Results
A total of 12,227 patients were treated at our hospital during the first four waves of the pandemic. 54.8% were female, with median age of 45 years (IQR: 31 - 62). 68.5% were classified as mild COVID-19, 8.8% as moderate, and 22.68% as severe. 5.49% of patients were pregnant. Of all patients, 24.30% received corticosteroids upon admission, 11.6% developed secondary infections, and 8.4% died. Mild COVID-19 cases were 1,988 (wave 1), 2,147 (wave 2), 1,628 (wave 3), and 1,608 (wave 4). The proportions of corticosteroid used by waves were 4.3%, 7.18%, 12.5%, and 8.1%, respectively. Corresponding proportions for secondary infections were 2.80%, 5.26%, 6.14%, and 3.8%, while death proportions were 1.7%, 2.5%, 3.2%, and 2.1%. A positive correlation was found between corticosteroid use and secondary infection and mortality rates (Fig. 1). Correlation coefficients were r= 0.9 (p= 0.09) for corticosteroid use and mortality, r= 0.84 (p= 0.15) for corticosteroid use and secondary infection, and r= 0.94 (p= 0.01) for secondary infection and mortality. These correlations were not observed in moderate and severe COVID-19 cases
Relationship between corticosteroid use, secondary infection and mortality in patients with COVID-19
A. Relationship in mild COVID-19 patients. B. Relationship in moderate-to-severe COVID-19 patients

Conclusion
Our study shows that the use of corticosteroids in mild cases could correlate with a greater proportion of secondary infections and mortality

Disclosures
All Authors: No reported disclosures
452. Ongoing Surveillance of SARS-CoV-2 for In Silico Analysis to Monitor the Performance of SARS-CoV-2 Assays in BIOFIRE® Panels
Authors: Horrocks Eleanor K , Todorov Toma , Debernardi Alexandra , Spaulding Usha , Robinson Tanner , Antosch Jeremiah , Lu Zhenmei , Jones Matthew , Cloud Joann 
Published: November 2023

Abstract

Background
In response to the COVID-19 pandemic, bioMérieux has incorporated assays to detect SARS-CoV-2 into the BIOFIRE® Respiratory 2.1 (RP2.1) Panel, the BIOFIRE® SPOTFIRE® Respiratory (R) Panel and the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini. All panels use two assays for SARS-CoV-2 detection, each targeting a different gene. Positive detection in only one of the two assays is required for a positive SARS-CoV-2 result. As new variants of SARS-CoV-2 emerge, in silico analysis remains crucial to ensure that both SARS-CoV-2 assays are reactive to circulating strains.

Methods
Sequence data (https://gisaid.org/) for SARS-CoV-2 variants deemed significant by the WHO and UKHSA are analyzed monthly. Assay primer regions are assessed for mismatches using Geneious Prime® as well as proprietary software tools. When primer mismatches with potential to affect the sensitivity of SARS-CoV-2 detection are identified (mismatches occurring in the 3’ half of a primer in both assays), and meet the testing criteria, the BIOFIRE RP2.1 Panel is used to empirically evaluate the impact by comparing synthetic templates with mismatches of concern to synthetic template without mismatches.

Results
As of March 21, 2023, nearly 1,000 variants and 12,744,136 sequences have been analyzed. Of these, only 481 sequences (0.0038%) contain paired mismatches of concern. Wet testing showed &lt; 10x lower projected sensitivity for 288 (72 unique) sequences, 10-100x lower sensitivity for 16 (10 unique) sequences, and only 1 sequence had 100-1000x lower projected sensitivity. Lineage defining mutations were seen within a SARS-CoV-2 assay primer region in 27 variants. However, most lack mutations in the second assay, indicating no major risk for SARS-CoV-2 detection. Wet testing shows that the inclusion of two SARS-CoV-2 assays in the panels helps to mitigate the effect of mismatches of concern.

Conclusion
Based on the comprehensive in silico analysis of available sequences and variants, BIOFIRE RP2.1 Panel, SPOTFIRE R Panel and SPOTFIRE R Panel Mini continue to function as intended with &gt;99.99% detection of SARS-CoV-2 sequences.

Disclosures
Eleanor K. Horrocks, bioMerieux: employee|bioMerieux: Stocks/Bonds Toma Todorov, n/a, bioMerieux: employee|bioMerieux: Stocks/Bonds Alexandra Debernardi, n/a, bioMerieux: employee|bioMerieux: Stocks/Bonds Usha Spaulding, n/a, bioMerieux: employee|bioMerieux: Stocks/Bonds Tanner Robinson, n/a, bioMerieux: employee|bioMerieux: Stocks/Bonds Jeremiah Antosch, n/a, bioMerieux: employee|bioMerieux: Stocks/Bonds Zhenmei Lu, n/a, bioMerieux: employee|bioMerieux: Stocks/Bonds Matthew Jones, MS, bioMerieux: employee|bioMerieux: Stocks/Bonds Joann Cloud, PhD, bioMerieux: employee|bioMerieux: Stocks/Bonds
459. Characteristics and Presentations of Hospitalized Children due to three predominate COVID-19 variants within a healthcare network
Authors: Bhavsar Sejal M , Clouser Katharine N , Connolly Hailey , Gadhavi Jasmine , Kaur Ranbir , Lozy Tara , Naganathan Srividya , Pierre Margarette , Cruz Mariawy Riollano , Shah Pooja , Siu Anita , Swenson Carly , Ballance Cathleen M 
Published: November 2023

Abstract

Background
Variants of SARS-CoV-2 caused three major waves of infections in NJ. Children and young adults were hospitalized with varying symptoms and severity of illness depending on the variant. The objectives of this study are to describe differences in the demographic and clinical characteristics, severity of illness and outcomes in pediatric patients during the different SARS-CoV-2 waves in our hospital network.

Methods
We conducted a retrospective study of pediatric patients admitted to one of our three network hospitals with SARS-CoV-2 infection or with post-COVID-19 inflammatory conditions such as Multisystem Inflammatory Syndrome in Children (MIS-C) during the different waves of infection. Patients who were asymptomatic but incidentally tested positive for SARS-CoV-2 and were hospitalized for unrelated indications were excluded. We defined the timelines as follows: Wave 1 occurred between March 1, 2020 and May 31, 2020; wave 2 occurred between November 1, 2020-January 31, 2021; and wave 3 occurred between December 1, 2021-February 28, 2022. Demographic characteristics, clinical features, and outcomes were recorded and compared with respect to the different variants.

Results
Of 351 total patients included in this study, 74 were admitted during wave 1, 94 during wave 2, and 181 during wave 3. The median age of patients decreased from wave 1 (11.5 years) to wave 3 (3 years) (p=0.0034). 87.7% of the patients were unvaccinated. The overall incidence of admissions related to COVID-19 pneumonia decreased in wave 3 compared to wave 1 and 2. COVID-19 bronchiolitis or croup admissions occurred mostly in wave 3. No significant difference in intensive care admissions was observed in any wave. Length of stay decreased across the waves (p&lt; 0.0001). Treatments required did not vary between the waves except for a decrease in antibiotic use with each subsequent wave (p&lt; 0.0001).

Conclusion
The impact of COVID-19 on the pediatric population differs from the adult population, and the overall numbers of hospitalized children has mirrored the peak in cases observed during each infection wave. Our study illustrates the changes in clinical presentation and severity observed with the different coronavirus variants.

Disclosures
Tara Lozy, MA in Data Science, Eli Lilly & Company: Stocks/Bonds
460. SARS-CoV-2 Infection-Induced Antibody Seroprevalence in Previously Infected Persons with Immunocompromising Conditions — United States, 2020–2022
Authors: Bratcher Anna , Jones Jefferson M , Harris Aaron , Clarke Kristie E N 
Published: November 2023

Abstract

Background
People with immunocompromising conditions (IC) are at increased risk of severe COVID-19 and death. These individuals show weaker immunogenicity following vaccination than individuals without IC, yet immunogenicity after SARS-CoV-2 infection is poorly understood. To address this gap, the presence of infection-induced antibodies in sera following a positive COVID-19 test result was compared between people with and without IC.

Methods
Data were from CDC’s national commercial laboratory seroprevalence study, a repeated, cross-sectional survey that includes associated diagnostic codes and previous COVID-19 viral test results. Infection-induced antibody seroprevalence in sera from people with a positive COVID-19 test result was compared by IC status for three post-infection periods: 14–90 (early), 91–180 (mid), and &gt;180 (late) days. A logistic regression produced adjusted odds ratios (aOR) comparing infection-induced antibody prevalence among specimens with and without associated IC adjusted for age, sex, and infection-induced antibody assay used (Abbott Architect, Ortho VITROS, or Roche Elecsys).

Results
The analytic sample consisted of 15,554 specimens across the three periods (4,571 early, 4,465 mid, and 6,518 late). Of these, 188, 157, and 283 specimens had one or more associated, recorded IC, respectively. During the early period, 22.3% of specimens with IC lacked infection-induced antibodies compared with 6.8% of those without IC. After adjustment, specimens with IC were more likely to lack infection-induced antibodies in the early (aOR: 4.85; 95% CI: 3.20–7.38), mid (aOR: 2.53; 95% CI:1.57–4.09), and late (aOR:1.62; 95% CI:1.12–2.36) periods compared to specimens without IC.

Conclusion
Sera from people with IC is less likely to contain infection-induced antibodies following SARS-CoV-2 infection compared to sera from those without IC within the studied periods. These findings stress the importance of prevention measures for people with IC, such as pre-exposure prophylaxis, additional vaccination doses, and consistent mask use before and after a documented infection.

Disclosures
All Authors: No reported disclosures
465. Use of Monoclonal Antibodies for COVID-19 in Solid Organ Transplant Recipients: A Single-Center Experience
Authors: Gomez Keven , Arcobello Jonathan T , Chang Sandy 
Published: November 2023

Abstract

Background
The use of coronavirus disease 2019 (COVID-19) monoclonal antibody (mAb) treatment in solid organ transplant (SOT) patients have been shown to reduce the rates of hospitalization, Emergency Department (ED) visits, and mortality in previous studies. However, most of these studies provide little or no data in minority patients, specifically Hispanic patients, a group that has been associated with worse outcomes with COVID-19. Our study describes the use of COVID-19 mAbs in the SOT recipients at our institution, where a majority of patients are of Hispanic ethnicity.

Methods
We performed a retrospective chart review of all adult SOT patients who received COVID-19 mAbs from December 2020 to December 2022.

Results
We identified 54 patients who were SOT recipients. The mean age was 46.3 (IQR 33-59), and 30 (55.6%) were male. Of the 54 patients, 34 (63.0%) identified as Hispanic, 17 (31.5%) as White, 2 (3.7%) as Asian, and 1 (1.9%) as Black. There were 23 (42.6%) heart, 22 kidney (40.7%), 6 liver (11.1%), 2 (3.7%) combined kidney and liver, and 1 (1.9%) combined kidney and pancreas recipients. There were four mAbs available during the study period. Of the 54 SOT recipients, 16 (29.6%) received casirivimab/imdevimab, 5 (9.3%) received bamlanivimab, 19 (35.2%) received bebtelovimab, and 14 (25.9%) received sotrovimab. Average time from symptom onset to receipt of infusion was 4 (IQR 1-5) days. The 30-day hospitalization rate due to COVID-19 from time of diagnosis in our cohort was 5.6%. There were 3 (5.6%) patients who visited the ED due to COVID-19 within 30 days of diagnosis and there were no deaths due to COVID-19 within 30 days of diagnosis. When comparing between the Hispanic and non-Hispanic groups in our cohort, the 30-day hospitalization rate due to COVID-19 from time of diagnosis was not statistically significant (5.6% vs 0, p=0.29). There was one patient who had an infusion reaction and 3 patients who developed allograft rejection within 90 days of mAb infusion.

Conclusion
In our small cohort of SOT recipients, the majority of which are Hispanic, use of COVID-19 mAbs had low rate of poor outcomes and adverse events. There was no statistically significant difference in hospitalization rate following mAb infusions between the Hispanic and non-Hispanic SOT recipients in our group.

Disclosures
All Authors: No reported disclosures
469. Outcomes of COVID-19 among hospitalized patients under Rituximab: the experience of a Portuguese hospital
Authors: Gonçalves Maria João M S , Pena Eduarda , Duarte Frederico , Oliveira Susana , Batista Clara , Guimarães Mário , Abreu Ricardo Correia , Neves Isabel , Jordão Sofia 
Published: November 2023

Abstract

Background
Rituximab (RTX) is a monoclonal antibody commonly used for various hematological and autoimmune disorders. B-cell–depleting therapies also blunt humoral responses to SARS-CoV-2 vaccines. Whether this carries an increased risk of hospitalization or death from COVID-19 is unclear.

Methods
We conducted a retrospective study of hospitalized patients with COVID-19 who received RTX prior to hospitalization (maximum 18 months before). We analysed their outcomes, including length of stay, antiviral treatment, inflamatory markers and mortality.

Results
A total of 43 hospitalized COVID-19 patients who received RTX were included in the study (from April 2020 to April 2023) . The median age was 67 years (range, 25-88), and 58% were female. The average length of stay was 28 days (range, 1-29). Upon admission, average value of severity predictor markers: CRP 94.6 mg/L, procalcitonine 0.66 ng/mL, lactate dehydrogenase (LDH) 383.5 U/L, D-dimers 1530.3 ng/mL. Treatment was performed in 44% with dexamethasone and in 48% with remdesivir. The mortality rate was 42%.

Conclusion
In our study, previous treatment with rituximab was associated with high severity predictor markers and serious outcomes of COVID-19.
Patients and healthcare professionals should be aware of the risk associated with COVID-19 in this population. Clinicians must choose carefully patients for anti-CD20 treatments. Preventive measures, active and passive immunization, as well as early antivirals therapy may decrease COVID-19 severity.

Disclosures
All Authors: No reported disclosures
488. Initial laboratory markers may help distinguish between Kawasaki Disease and Multisystem Inflammatory Syndrome in Children
Authors: Miretzky Shir , Clouser Katharine N , Bhavsar Sejal M , Baer Aryeh Z , Sagcal-Gironella Anna Carmela , Pinto Jamie M , Tozzi Meghan , Patel Vaidehi 
Published: November 2023

Abstract

Background
In May of 2020, the Centers for Disease Control and Prevention defined a new diagnosis, Multisystem Inflammatory Syndrome in Children (MIS-C), described as a Kawasaki-like illness and related to the SARS-CoV-2 virus. Patients with this syndrome met criteria for inflammation, along with multiple organ system involvement. Clinically distinguishing between Kawasaki Disease (KD) and MIS-C is challenging due to significant overlap between the two disease entities. Furthermore, approximately 25-50% of MIS-C cases also meet criteria for KD. Currently there is very limited data describing specific differences in laboratory markers between KD and MIS-C to guide clinicians in diagnosis and management. This study aims to assess if quantitative laboratory data markers help distinguish between KD and MIS-C.

Methods
We conducted a retrospective study of patients hospitalized within two network pediatric hospitals with the diagnosis of MIS-C [M35.81] or Kawasaki Disease [M30.3] between January 1, 2019 and March 31, 2021. Children with an alternate diagnosis at discharge were excluded. Demographic characteristics and laboratory data were recorded and analyzed.

Results
A total of 91 pediatric patients were included in the study: 40 with MIS-C and 45 with KD. Patients with MIS-C were significantly older with a median age 5.3 years, compared to 2.4 years for KD (p=0.001). Patients with KD presented with higher median white blood cell (WBC) count, absolute lymphocyte count, and platelet count compared to those with MIS-C (p&lt; 0.001). A higher alanine aminotransferase (ALT) was also noted (p=0.01). Patients with MIS-C were noted to have higher median ferritin levels and C-reactive protein (CRP) (p&lt; 0.001) (Table 1).

Conclusion
Both MIS-C and KD are autoinflammatory disease processes that have significant overlap. Identifying differences in initial laboratory values upon presentation can lead to earlier diagnosis. A normal ferritin level may indicate KD.

Disclosures
All Authors: No reported disclosures
497. Safety and tolerability of 2000mg intravenous sotrovimab dose in immunocompromised participants uninfected with SARS-CoV-2 in the PROTECT-V trial
Authors: Dosanjh Davinder , Qian Wendi , Dowling Francis , Crowley Louise , Chen-Xu Michael , Smith Rona M 
Published: November 2023

Abstract

Background
There remains a need for pre-exposure prophylaxis against SARS-CoV-2 infection in vulnerable patients in whom response to vaccination is often sub-optimal. The PROTECT-V platform trial is testing pre-exposure prophylactic interventions for COVID-19 in vulnerable patient populations: transplant recipients, individuals with oncological/haematological diagnoses, immune deficiency, autoimmune diseases requiring immunosuppression, and individuals receiving dialysis.

Methods
Sotrovimab is a dual-action monoclonal antibody and the second agent to be added to the PROTECT-V platform (Clinicaltrials.gov: NCT04870333; EudraCT: 2020-004144-28). Although a single sotrovimab 500mg intravenous (IV) dose has been widely used for early treatment, data on a 2000mg IV dose are limited. Tolerability data in the first 143 participants randomized to this arm of the trial are presently available. Patients are randomized 1:1 sotrovimab to placebo. Data remain blinded.

Results
Median age was 66 years (range 21 – 86) and 82 (57%) patients were female. 132 (96%) had received ≥3 doses of SARS-CoV-2 vaccine. Patient populations were: 82 (57%) autoimmune disease; 26 (18%) haematological/oncological diseases; 21 (15%) transplant recipients; 12 (8%) immunodeficiency; 2 (1%) on dialysis.
Two (1%) participants experienced a mild infusion related reaction (IRR). The infusion was briefly interrupted, but completed. Thirty (21%) participants experienced at least one symptom in the 24 hours post-infusion, but none were severe or required hospital admission. The most common symptoms were dizziness (7 [5%]), headache (7 [5%]), rigors (5 [4%]) and fever (4 [3%]). No severe adverse events were reported within 72 hours of IMP infusion at the time of writing.
The first 55 patients underwent routine hematological and biochemical blood test evaluation 72 hours post-infusion. Ten events from 9 participants exhibited worsening of laboratory parameters, meeting at least grade two DAIDS criteria or worse. None of these were clinically significant.

Conclusion
A 2000mg IV dose of sotrovimab was tolerated well in this blinded analysis of immunocompromised participants, with no severe IRRs or significant change in haematological or biochemical markers up to 72 hours post infusion.

Disclosures
Davinder Dosanjh, n/a, Astrazeneca: Honoraria|Astrazeneca: Employee|Boehringer Ingelheim: Advisor/Consultant|Boehringer Ingelheim: Honoraria|Gilead: Advisor/Consultant|GSK: Grant/Research Support|Synairgen: Advisor/Consultant Louise Crowley, n/a, GSK: Grant/Research Support Michael Chen-Xu, n/a, GSK: Grant/Research Support Rona M. Smith, MD MRCP, GSK: Grant/Research Support|Union Therapeutics: Grant/Research Support
501. Risk Factors for Persistent Active COVID-19 Among Patients Receiving B-Cell Depleting Therapy versus Non-B-Cell Immunosuppression
Authors: Voll Kevin , Kartes Jacob , Spivak Emily S , Imlay Hannah 
Published: November 2023

Abstract

Background
Cases of COVID-19 characterized by prolonged replication of SARS-CoV-2 (persistent active COVID [PAC]) have been reported among immunocompromised patients, particularly those receiving B-cell depleting therapy (BCDT); however, the risk has not been quantified. We aimed to identify risk factors associated with PAC, including quantifying the risk associated with receipt of BCDT vs. other types of immunosuppression.

Methods
We retrospectively identified four groups of immunocompromised patients who tested positive for SARS-CoV-2 between 4/01/2020 and 4/30/2021. These groups included one group of patients who received an anti-CD20 BCDT within 1 year before a positive SARS-CoV-2 PCR and three groups who received non-BCDT which included hematopoietic cell transplant (HCT) recipients, solid organ transplant (SOT) recipients, and patients receiving chemotherapy for hematologic malignancies (HM). Chart review was performed to characterize the clinical course and development of PAC, which was defined as any of the following: (1) initial clinical improvement followed by progression of illness extending beyond 14 days, characterized by persistent fevers or progressive respiratory failure; or (2) persistent symptoms with demonstration of absent seroconversion ≥ 14 days into illness. This distinction may be supported by low crossing thresholds that occurred ≥ 14 days into illness. Logistic models were performed to identify factors associated with development of PAC and other COVID outcomes.

Results
We identified 67 COVID-positive patients who had received BCDT as well as 30 HM, 118 SOT, and 29 HCT patients. PAC occurred in 15/67 (22%) of patients receiving BCDT vs. 3/177 (1.7%) patients (all SOT recipients) in the non-BCTD group (SOT, HCT, HM) (Odds Ratio, 16.7; 95% confidence interval [CI] 4.7 to 60.0; p=0.00005). 30-day hospitalization and 90-day mortality were similar in BCDT and non-BCDT groups (Table 1, Figure 1) (p &gt; 0.05).
Table 1.
Risk factors for specific outcomes of COVID-19
Figure 1.
Proportion of patients from each cohort of immunocompromised patients who developed persistent active COVID (1A), required hospitalization within 30 days (1B), required mechanical ventilation (1C), required ICU admission (1D), or died within 90 days after diagnosis of COVID-19 (1E)

Conclusion
Receipt of BCDTs was significantly associated with the development of PAC in comparison to other forms of severe immunosuppression. However, rates of severe outcomes associated with COVID-19 were similar across all groups. More research is necessary to determine effective prevention or treatment strategies for PAC.

Disclosures
All Authors: No reported disclosures