bluuebunny/crossref_metadata_2025_split huggingface dataset:
545. A Retrospective Review of 30-day Mortalities in Solid-Organ Transplant Recipients (SOT) versus Non-Transplant Patients (NTP) Receiving Remdesivir (REM) and Dexamethasone (DEX) for COVID-19 Pneumonia
Authors: Vyas Krina , Epps Kevin L , Zhang Nan , Shah Sadia , Soto-Arenall Matthew , Brumble Lisa , Libertin Claudia R 
Published: December 2021

Abstract

Background
Treating COVID-19 infection in SOT is challenging due to long-term use of immunosuppressive agents. REM is the only FDA-approved anti-viral for SARS-COV-2 infection. DEX showed decrease in mortality in the Recovery Trial. COVID-19 treatment guidelines for SOT patients are the same as NTP despite limited literature on those outcomes. Our primary objective was to determine if 30-day mortality was different between SOT and NTP matched cohorts using these 2 drugs. The secondary objectives included comparisons of length of stay (LOS), days on mechanical ventilation (DMV), and the use of other treatment modalities.

Methods
We retrospectively collected data for hospitalized SOT and NTP, 18 years and older, with pcr-confirmed SARS-CoV-2 infection receiving REM and DEX from May 1, 2020, to October 10, 2020, at Mayo Clinic Florida. IRB approval was obtained. Descriptive statistics were used to analyze the data. Continuous variables were summarized as mean (standard deviation) or median (range) where appropriate, while categorical variables were reported as frequency (percentage).

Results
Of 80 patients who met the inclusion criteria, 28 were SOT, and 52 were NTP. The SOT cohort was subcategorized below:
SOT patients were significantly younger than NTP (p &lt; .001). Further, SOT patients had significantly longer LOS (p = 0.043) and more COVID-19 modalities (75% vs. 36.5%, p = 0.002) compared to NTP. Among the 28 SOT patients, 2 of them died within 30 days of admission, and among the 52 NTP patients, 7 of them died within 30 days. The 30-d survival estimate for SOT group is 92.9% (95% CI: 83.8% - 100.0%) and for NTP group is 86.5% (95% CI: 77.7% - 96.3%). The log-rank test was not significant between the groups (p=0.37), but the NTP has a worse survival curve from the figure below.
SOT-NTP Survival Curve

Conclusion
SOT group was younger, had longer LOS, and more COVID-related modalities. The 30-d survival estimate for SOT group is 92.9% and for NTP group is 86.5%, but the survival curve for NTP was worse likely secondary to age. Use of REM & DEX in SOT recipients is a valid recommendation.

Disclosures
Claudia R. Libertin, MD, Gilead (Grant/Research Support)
547. Risk Factors Associated with 30-Day Mortality in a Large Cohort of Patients who Received Remdesivir and Corticosteroids for Severe COVID-19
Authors: Gupta Kartik , Monday Lea , Kaushik Milan , Alangaden George J , Brar Indira 
Published: December 2021

Abstract

Background
Remdesivir (RDV), an antiviral agent, is approved by Food and Drug Administration (FDA) for the treatment of patients (pts) admitted with SARS-COV-2 infection (COVID-19). Earlier RDV studies (such as ACCT-1) prior to widespread use of corticosteroids (CS), showed a 30-day mortality of 11%. Advanced age, obesity, and certain comorbidities are known risk factors for death in COVID-19, but whether these risks vary in pts treated with RDV and CS is unknown. As of March 20, 2020 CS were routinely used for the treatment of pts admitted with COVID19 in our health care system. The objective of this study was to identify risk factors associated with 30 -Day mortality in a cohort of pts admitted with COVID-19 and who received RDV and CS.

Methods
This retrospective cohort study evaluated pts admitted to a health system in South East Michigan with COVID-19 between March and November 2020 who received ≥1 dose RDV. Demographics, comorbidities, and characteristics including quick sequential organ failure assessment (qSOFA) score were collected and compared between patients who died versus survived. Primary outcome was 30 day mortality. Secondary outcomes were risk factors for death using logistic regression and time-to-event analysis.

Results
A total of 1,591 pts received RDV and were included in the study; median age 67 years, 56% male and 18% Black. RDV use increased after emergency use authorization and FDA approval (Fig 1). Death within 30 days occurred in 15.3%. Patients who died were older males with higher rates of hypertension, kidney disease, diabetes, and were more likely to have qSOFA ≥2 on arrival (Table 1). In a multivariable logistic model, advanced age, male gender, pulmonary disease, CKD, obesity, and qSOFA≥2 were independent predictors of death (Figure 2). Among these, age and qSOFA≥2 were the most important risk factors (Figure 2).

Patients receiving remdesivir (red) were included in the study. Routine use of corticosteroids was adopted on all patients in our health system beginning March 20, 2020. System-wide use of remdesivir increased following Food and Drug Administration approval in fall 2020.

On both logistic regression and time-to-event analysis, advanced age and qSOFA ≥ 2 had the highest predictive value for mortality. Others comorbidities were similar and comparable in importance.

Conclusion
The population in our Real-world study was older with more comorbidities as compared to ACCT-1, and the 30 day mortality was 15%. Despite the use of CS and RDV advanced age and qSOFA were the most important drivers of mortality. Future, therapeutic strategies need to focus on this group which is at the highest risk of dying from COVID-19 infection.

Disclosures
All Authors: No reported disclosures
548. Convalescent Plasma in Hospitalized Pediatric and Obstetric patients with COVID-19
Authors: Ikeda Saki , Benzi Eduardo , Hensch Lisa , Devaraj Sridevi , Hui Shiu-Ki Rocky , Gandhi Manisha , Fox Karin , Teruya Jun , Munoz Flor M 
Published: December 2021

Abstract

Background
Published data on COVID-19 convalescent plasma (CCP) use in children and obstetric patients is limited. We describe a single-center experience of hospitalized patients who received CCP for acute COVID-19.

Methods
We performed a retrospective review of children 0-18-years-old and pregnant patients hospitalized with laboratory-confirmed acute COVID-19 who received CCP from March 1st, 2020 to March 1st, 2021. Clinical and laboratory data were collected to assess the safety of CCP administration. Antibodies to SARS-CoV-2 were measured before and at various timepoints post CCP transfusion. Correlation between SARS-CoV-2 immunoglobulin administered versus the SARS-CoV-2 anti-Spike immunoglobulin response in patient serum was assessed.

Results
Twenty-two children and 10 obstetric patients were eligible. 12 pediatric and 8 obstetric patients had moderate disease and 10 pediatric and 2 obstetric patients had severe disease. 5 pediatric patients died. 18/37 (48.6%) CCP units that were measured met FDA criteria for a high IgG titer. There were no complications with transfusion based on CDC, NHSN Biovigilance Component: Hemovigilance Module Surveillance Protocol. Two pediatric patients had fevers a few hours after CCP with low suspicion for a transfusion reaction. Median SARS-CoV-2 anti-spike antibody levels of pediatric patients post-transfusion for 0-7 days was 80.6AU/mL (range: 2-1070), 8-21 days was 180AU/mL (range: 12-661) and &gt;21 days was 210AU/mL (range: 4.1-1220). For obstetric patients, post-transfusion antibody levels were only obtained 0-7 days post-transfusion with median 45AU/mL (range: 9.5-100). High-titer CCP showed a positive correlation with rise in patient immunoglobulin levels only in the obstetric patients but not in pediatric patients.

Conclusion
CCP was administered safely to our moderately to severely ill pediatric and obstetric patients. Among pediatric patients, the median serum antibody level increased over time after transfusion and suggested that CCP did not interfere with the endogenous antibody production. Antibody dose of high-titer CCP correlated with post-transfusion response in only obstetric patients. Randomized trials in pediatric and obstetric patients are needed to further understand how to dose CCP and evaluate efficacy.

Disclosures
Jun Teruya, MD, PhD, Apelo Consulting Pvt. Ltd (Consultant)Hemosonics (Other Financial or Material Support, Honorarium) Flor M. Munoz, MD, Biocryst (Scientific Research Study Investigator)Gilead (Scientific Research Study Investigator)Meissa (Other Financial or Material Support, DSMB)Moderna (Scientific Research Study Investigator, Other Financial or Material Support, DSMB)Pfizer (Scientific Research Study Investigator, Other Financial or Material Support, DSMB)Virometix (Other Financial or Material Support, DSMB)
549. Monoclonal Antibody Therapy for COVID-19 Infection in Michigan: The Flint Experience
Authors: Younas Mariam , Osterholzer Danielle , Flues Brandon R , Rios-Bedoya Carlos , McDonald Philip , Bachuwa Ghassan , Tupper Michael W , Jaggi Michael 
Published: December 2021

Abstract

Background
Bamlanivimab (BAM), a neutralizing IgG1 monoclonal antibody (mAb), received emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) for treatment of mild to moderate COVID-19 infection in patients 12 years of age and older weighing at least 40 kg at high risk for progressive and severe disease on Nov 10, 2020. The purpose of this study is to describe our experience with this treatment modality.

Methods
Hurley Medical Center (HMC), is a 443-bed inner city teaching hospital in Flint, MI. HMC administered its first BAM infusion on Nov 19, 2020. Through April 30, 2021, 407 patients with confirmed SARS-CoV-2 infection, received a mAb infusion. 62/407 patients received the combination mAb therapy of BAM + Etesevimab, as the EUA for BAM monotherapy was revoked on 04/16/21. We retrospectively collected basic demographic data and hospitalization to our facility within 14 days of receiving mAb therapy on these patients.

Results
During the 5.5 month study period, patients receiving mAb therapy at HMC had a mean age of 56 years (yrs) (± standard deviation) (± 15.4) and a mean Body Mass Index (BMI) of 34 kg/m² (± 8.5) (Tables 1,2). African Americans (AA) comprised 48% (194/407) (Table 3) and females comprised 54% (220/407) of the cohort. 6% (25/407) of the patients required hospitalization within 14 days of mAb infusion, had a mean age of 58 yrs (± 17) (p-value 0.62) and a mean BMI of 32 kg/m² (± 9) (p-value 0.33). Females and AA comprised 56% (14/25) and 48% (12/25) of this subgroup respectively (p-value 1.0). No deaths were reported within 30 days of infusion in this cohort.

Conclusion
Previously published reports cite a hospitalization rate in untreated high-risk COVID-19 infected patients of 9-15%. During the period of study, the county hospitalization rate and county mortality rate for all comers with COVID-19 was 6.6% and 2.7% respectively while our high risk cohort had a hospitalization rate of 6% and with no deaths reported. Our cohort had much lower rates of hospitalization and death than would be expected especially in a group which comprised of 48% AA in an underserved area. mAb therapy seems to have a protective effect with significant reduction in the hospitalization and mortality rate among high-risk patients with COVID-19 infection and should be prioritized for administration.

Disclosures
All Authors: No reported disclosures
550. Bamlanivimab and Casirivimab/Imdevimab Treatment Outcomes: Results from a Large Healthcare System’s Structured Implementation Experience
Authors: Polk Christopher , Jacobs Anna , Sampson Mindy , Leonard Michael , Medaris Leigh Ann , Branner Christopher , Goel Vineet , Davidson Lisa 
Published: December 2021

Abstract

Background
Neutralizing antibody therapies targeting SARS-CoV-2 have been released for emergency use authorization by the FDA. Little is published on their real-world experience. In this retrospective study we share the results of our early experience on patient outcomes from use of these neutralizing antibodies within a large healthcare system.

Methods
We retrospectively analyzed results of a healthcare system wide program to pro-actively identify and treat COVID-19 patients with neutralizing antibody therapy.

Results
The 449 patients identified for SARS-CoV-2 neutralizing antibody therapy during the study period were retrospectively classified as falling in one of the three groups: untreated (199), bamlanivimab (87) and casirivimab/indevimab (125) treated patients (Table 1). Reasons identified patients were not treated most commonly were patient declined (n=74), unable to be contacted (n=36), out of treatment window (n=23), asymptomatic and feeling better (n=21) or did not have transportation (n=9). Bamlanivimab infusion did not reduce emergency room (ER) visits or hospitalization compared to untreated patient within 30-days of follow up (Table 2), and among all patients treated with antibody therapy only treatment with bamlanivimab and non-white race were predictors of need for hospitalization (Table 3). Casirivimab/indevimab did reduce subsequent ER visits or hospitalization within 30 days post-infusion when compared to the untreated group. However, patients treated with either antibody therapy had lower acuity of COVID-19 disease as reflected in need for intensive care unit (ICU) stay, mechanical ventilation or death (Table 2).
Table 1. Characteristics of infused vs uninfused patients

Table 2. Outcomes in treated vs untreated patients

Table 3. Risk factors for ED visits or hospitalization in infused patients

Conclusion
Either neutralizing antibody therapy appears to markedly reduce acuity of COVID-19 disease even if patients do progress to requiring hospitalization. However, casirivimab/indevimab therapy also decreased ER visits and hospitalization suggesting better efficacy in our experience.

Disclosures
Christopher Polk, MD, Atea (Research Grant or Support)Gilead (Advisor or Review Panel member, Research Grant or Support)Humanigen (Research Grant or Support)Regeneron (Research Grant or Support) Mindy Sampson, MD, Regeneron (Grant/Research Support)
553. Outcomes in Patients Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection After Treatment with Monoclonal Antibody Therapy (MAT) in the Outpatient Setting
Authors: Nichols Courtney , Lustberg Mark , Sobhanie Mohammad Mahdee , Lehman Joy , Reed Erica E , Kman Nicholas E , Conroy Mark , Dick Michael , Allen James N , Parsons Jonathan , Malvestutto Carlos 
Published: December 2021

Abstract

Background
Monoclonal antibody therapy (MAT) was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with positive SARS-CoV-2 viral testing and at high risk for progression to severe COVID-19 with up to 10 days of symptoms. This study assessed the impact of MAT on COVID-19-related ER visits, admissions, and mortality for patients diagnosed with COVID-19.

Methods
This was a single-center, retrospective study at The Ohio State University Wexner Medical Center to compare COVID-19-related ER visits, admissions, and mortality at 30 days after receiving MAT in the outpatient setting with either bamlanivimab or casirivimab-imdevimab in adult patients diagnosed with SARS-CoV-2 between November 16, 2020 and February 2, 2021. Outcomes in patients who received MAT were compared to those of a control group of patients diagnosed with COVID-19 in the outpatient setting from May 16, 2020 through November 15, 2020 who would have qualified for MAT through EUA criteria had it been available. Statistical analysis used logistic regression analysis with backward selection to determine the odds ratios (OR) and the 95% confidence interval to evaluate the relationship between patient clinical characteristics and outcomes.

Results
This study cohort included 1,944 patients, including 943 who received MAT and 1,001 in the control group. The MAT group included 658 who received bamlanivimab and 285 who received casirivimab-imdevimab. Patients who received MAT compared to the control group had a lower rate of COVID-19 related ER visits (3.3% vs 7.4%, p = &lt; 0.0001) and hospital admissions (4.0% vs 7.8%, p = &lt; 0.0001). No statistically significant difference was seen in mortality between the MAT group (0.5%) and control group (1.1%, p = 0.17). After accounting for potential confounders, the difference between the monoclonal antibody and control groups remained significant for ER visits and hospital admissions as reflected in the table.

Conclusion
Patients who received MAT for COVID-19 in the outpatient setting had a lower rate of COVID-19-related 30 day ER visits and hospitalizations compared to those who did not receive MAT, adjusting for potential confounders.

Disclosures
Mohammad Mahdee Sobhanie, M.D., Regeneron (Scientific Research Study Investigator)Regeneron (Scientific Research Study Investigator, Was a sub-investigator for Regeneron 2066 and 2069) Carlos Malvestutto, M.D., Lilly (Scientific Research Study Investigator)Regeneron Inc. (Scientific Research Study Investigator)ViiV Healthcare (Advisor or Review Panel member)
554. Clinical Impact of Monoclonal Antibody Therapy with SARS-CoV-2 Infection
Authors: Mann Inderjit , Monteforte Melinda , Go Roderick 
Published: December 2021

Abstract

Background
The novel coronavirus SARS-CoV2 is the causative agent for COVID-19 responsible for the ongoing global pandemic. The spike protein on its surface binds to the angiotensin-converting enzyme 2 receptor helps to enter human cells. Neutralizing antibodies to this protein can be protective and helpful in alleviating symptoms. Monoclonal antibodies (mAb) have been utilized in the U.S. under an emergency use authorization by the FDA, including bamlanivimab (BAM) and casirivimab-imdevimab (CAR/IMD). We report our experience of using COVID mAb.

Methods
We conducted a retrospective chart review of patients that received CAR/IMD or BAM between December 1st, 2020, and May 15th, 2021. Medical records were reviewed to determine demographic and clinical information as well as tolerability and effectiveness of mAb.

Results
463 patients with mild to moderate symptoms of SARS-CoV2 received mAb: 355(176 Men) BAM, 108(53 Men) CAR/IMD. The median BMI was 31 (17.4 to 62.5), 85% Caucasian, 4% Asian, 3% African American, 4% Hispanic, 4% others. The average duration of symptoms was 3.4 days and included cough (74%), malaise (71%), Headache (28%), dyspnea (28%), rhinorrhea (25%), fever (20%), diarrhea (18%), and anosmia (14%). Risk factors included hypertension (65%), diabetes mellitus (32%), coronary artery disease (22%), asthma (16%), COPD (9%), CHF (9%), CKD (8%), active malignancy (6%), and immunocompromised state (7%). Those who received BAM were older (p=0.000) and have underlying dementia and congestive heart failure (p=0.025 and 0.034, respectively). 27 patients (2 CAR/IMG, 25 BAM) got admitted to the hospital due to worsening of their respiratory status and were treated for COVID-19. 4 patients in the BAM group and 0 in the CAR/IMD group died. 2 patients developed a mild allergic reaction to CAR/IMD, no other side effects were reported in both groups. 37 patients (19 CAR/IMD, 18 BAM) received mRNA COVID vaccine prior. Overall mortality rate was 0.8%. There was no significant difference between BAM and CAR/IMR in terms of hospitalization (p= 0.104) or mortality (p=0.268).

Conclusion
Treatment with BAM versus CAR/IMR was well tolerated and resulted in similar outcomes in terms of hospitalization or mortality.

Disclosures
All Authors: No reported disclosures
555. Utilization of Remdesivir for COVID-19 in the National Veterans Affairs Healthcare System
Authors: Caffrey Aisling , Xin Liao J , Lopes Vrishali 
Published: December 2021

Abstract

Background
As remdesivir (GS-5734) has become a leading treatment for COVID-19, we sought to assess remdesivir utilization patterns, including utilization of concomitant and supportive therapies, and heterogeneity in treatment approaches.

Methods
Our retrospective cohort study included hospitalized Veterans with positive COVID-19 PCR tests treated with remdesivir, from 03/2020 through 4/2021. Using exposure mapping of barcode medication administration records and medication dispensings, we assessed other medications received by each patient on each day of remdesivir treatment. Heterogeneity was defined as patterns of treatment (drug & duration) not shared by any other patient.

Results
Our study included 13,665 patients with COVID-19 receiving remdesivir. The median time to remdesivir initiation from either positive test or hospital admission was 1 day (interquartile range [IQR] 0-4 and 0-1, respectively). The median duration of remdesivir treatment was 5 days (IQR 4-5 days). Median length of hospital stay was 7 days (IQR 4-13). Inpatient mortality was 13.9% and an additional 6.2% of patients died within 90 days of discharge. The most common concomitant and supportive therapies were anticoagulants/antiplatelets (94.8%; enoxaparin 72.6%, heparin 18.4%, apixaban 10.8%, clopidogrel 6.3%), corticosteroids (90.8%; dexamethasone 87.3%, prednisone 2.9%, methylprednisolone 5.5%), statins (55.8%; atorvastatin 38.2%, simvastatin 7.1%, rosuvastatin 6.0%), antibiotics (41.9%; azithromycin 25.6%, ceftriaxone 13.2%, doxycycline 6.0%, vancomycin 4.9%), angiotensin receptor blockers (11.9%) and angiotensin-converting enzyme inhibitors (20.4%), melatonin (29.7%), and aspirin (35.6%). Concomitant utilization of Janus kinase inhibitors (0.5%), interleukin-6 inhibitors (2.4%), and hydroxychloroquine (0.5%) was low. Heterogeneity in concomitant and supportive therapies during remdesivir treatment was 84.6% (68.3% when assessed as drug class/category).

Conclusion
Among hospitalized patients with COVID-19 in the national VA Healthcare system receiving remdesivir, remdesivir was initiated early in the admission and substantial heterogeneity was observed in concomitant and supportive therapies during remdesivir treatment.

Disclosures
Aisling Caffrey, PhD, Merck (Research Grant or Support)Pfizer (Research Grant or Support)Shionogi, Inc (Research Grant or Support)