bluuebunny/crossref_metadata_2025_split huggingface dataset:
531. Risk Factors and Therapeutic Interventions Associated with Mortality in Veterans Diagnosed With SARS-CoV-2 Infection (or COVID-19) Admitted to a Large Academic Medical Center
Authors: Welch Elwyn , Raheem Shazia , Hunter Andrew , Ayyala Uma , Bandi Venkata , Pandit Lavannya , Kao Christina 
Published: December 2021

Abstract

Background
Patient and treatment-related factors have been used to stratify COVID-19 outcomes; however, studies in the general population and specifically veterans have yielded variable results. This study was designed to assess how baseline characteristics and interventions correlate with clinical outcomes in patients admitted with COVID-19 at a large academic Veterans Affairs hospital.

Methods
Retrospective chart review was conducted on veterans admitted to the hospital with COVID-19 between March 1 to December 31, 2020. Veterans without respiratory symptoms attributed to COVID-19 or enrolled in a COVID-19 clinical trial were excluded. Primary outcome was in-hospital mortality up to 28 days. Secondary outcomes were 90-day mortality, discharge to higher level of care or remained in the hospital within 28 days, and discharge with new oxygen requirement within 28 days. Patient characteristics and therapeutic interventions were assessed for correlation with primary and secondary outcomes.

Results
Of 497 hospitalized patients reviewed, 293 were included for analysis; 94% were male; average age was 68 years with 64.9% of veterans greater than 65 years of age; 43.7% were Black; 17.4% were Hispanic. In-hospital mortality at 28-days and 90-day mortality were 18.1% and 21.5%, respectively. At discharge, 34.1% had a new oxygen requirement and 17.5% went to a higher level of care. Patients that died in-hospital were more likely to be greater than 65 years of age (p&lt; 0.001), Hispanic (p=0.007), have chronic kidney disease (CKD) (p=0.005), be admitted to ICU (p&lt; 0.001); receive dexamethasone (p&lt; 0.001), convalescent plasma (p&lt; 0.001), or antibiotics (p&lt; 0.001); require mechanical ventilation (p&lt; 0.001); or have new onset atrial fibrillation (p&lt; 0.001). Veterans also had higher levels of inflammatory markers within 48 hours of hospital admission (see Table 2) and longer length of hospital stay (&lt; 0.001). There was a trend for patients that died in the hospital within 28-days to be less likely to be Black (p=0.06).
Table 1. Primary and Secondary Outcomes of Study Population (n=293)

Table 2. Patient Characteristics Stratified by Primary Outcome

Table 3. Characteristics of the Patients that Survived to Discharge Stratified by Secondary Outcome Measures

Conclusion
Patients were more likely to die in-hospital within 28-days if they were greater than 65 years of age, Hispanic and had CKD. Veterans that died in-hospital within 28-days had higher inflammatory marker levels and were more likely to receive COVID-19 treatments.

Disclosures
All Authors: No reported disclosures
533. Protocol for and Efficacy of Monoclonal Antibody (mAb) Treatment of SARS-CoV-2 at a VA Medical Center
Authors: Nguyen Phuong Khanh , Dieringer Thomas D , Greeley Adela , Kun Suny , Calub Feliza , Pham My-Phuong , Graber Christopher J , Goetz Matthew B , Goetz Matthew B , Ikuta Kevin 
Published: December 2021

Abstract

Background
Bamlanivimab and casirivimab/imdevimab were the first monoclonal antibodies (mAb) developed against SARS-CoV-2 and proved beneficial early in the course of infection. However, real-world administration of these therapies presents logistical challenges. We present our experience implementing mAb treatment at a large VA Medical Center and review the efficacy of therapy in preventing hospitalization from COVID-19 in a closed healthcare system.

Methods
All positive outpatient COVID tests performed at VA Greater Los Angeles Healthcare System (GLA) were reviewed by the Emergency Medicine (EM) and Infectious Diseases (ID) Sections for mAb eligibility beginning 12/2/2020. Due to limited supply, treatment was prioritized for patients at highest risk of developing severe disease, as determined by EM/ID with input from a machine learning ensemble risk estimation model produced by VA National Artificial Intelligence Institute (Figure 1). If a patient declined or did not reply, treatment was offered to the next patient on a ranked eligibility list. Those who declined or were eligible but not treated were included in the analysis. Patients were excluded if they were hospitalized before treatment was offered. We collected data on age, comorbidities, date of diagnosis, and admission at 30 days after diagnosis. A multivariate log binomial regression was performed to determine the relative risk of admission within 30 days of diagnosis for those who received mAb therapy as compared to those who did not, adjusting for age and comorbidity. All analysis was done in R (version 4.0.5).

Results
139 patients met inclusion criteria. 45 (32%) received mAb therapy, 48 (35%) declined mAb therapy, and the remaining 46 (33%) either did not respond or were not offered mAb therapy. Hospitalizations following diagnosis in each group are illustrated in Figure 2. There was a trend towards reduced absolute and relative risk of hospitalization (Table 1). There were no anaphylactic events in patients who received mAb therapy.

Conclusion
At our facility, a system for rapid identification of candidates and a coordinated distribution plan was essential in ensuring timely administration of mAb therapy to eligible patients. Administration of mAb showed a trend towards decreased risk of hospitalization due to SARS-CoV-2.

Disclosures
Adela Greeley, MD, Kite (Other Financial or Material Support, My spouse is an employee) Matthew B. Goetz, MD, Nothing to disclose
534. The Use of Tocilizumab and Remdesivir in SARS- CoV-2 Patients in El Paso Texas: A Longitudinal Comparative Observational Study
Authors: Almaghlouth Nouf K , Anyiam Felix , Attia Mohamed , Robinson Matthew , Shah Sidra , Haq Syed , Guevara Roberto , Antony Suresh 
Published: December 2021

Abstract

Background
Currently, the management of SARS-CoV-2 varies with no definitive clinical guidelines, as scientific evidence across the globe differs in therapeutic options. This study intends to provide some clarity to the insufficient data based on the role of monotherapy with tocilizumab (TCZ) and combination therapy with remdesivir (RDV) and TCZ among patients in El Paso, Texas.

Methods
154 SARS-CoV-2-positive patients from four different hospitals in El Paso, Texas, were screened, with 113 eligible for this longitudinal comparative observational study (2/1/2020-10/31/2020). Group 1 (80 patients) were given TCZ within the first 24 hours of hospitalization, followed by methylprednisolone for 72 hours, and Group 2 (33 patients) received TCZ as detailed in the single therapy group, plus RDV within the first 24 hours. Mann Whitney U test assessed Median differences in laboratory biomarkers and Bivariate Logistic Regression assessed the odds of risk. An observation is said to be statistically significant if P-value is ≤ 0.05.

Results
A statistically significant increased median IL-6 values were noted among those given only TCZ compared to those that received TCZ plus RDV (511.33 vs. 199.0) with a P-value (0.007). Patients in Group 1 had statistically significant lower odds for ventilation use than Group 2 (OR=0.34, 95%CI=0.12-0.95, p=0.034), although no statistically significant difference in mortality outcomes was observed across groups (OR=0.43, 95%CI:0.13-1.39, p=0.269).
Table 1. Laboratory biomarkers and treatment groups (Mann Whitney U test)

Table 2. Clinical outcomes and treatment groups using the Bivariate Logistic regression (OR)

Conclusion
This study population is unique as it reflects a predominantly Hispanic demographic population in El Paso with different genetics, background characteristics, and predisposition to diabetes, and obesity than the rest of the United States (US). We concluded that the use of TCZ in SARS-CoV-2 positive patients in El Paso, with or without RDV, reported no mortality benefit. However, some minimal/non-use of ventilation benefit was observed in Group 1. Our study design is considered the first of its kind using TCZ and RDV in a longitudinal comparative observational study. Nonetheless, a randomized controlled trial study is recommended to ultimately determine the combination role of TCZ and RDV among this highly vulnerable group of patients.

Disclosures
All Authors: No reported disclosures
535. Comparison of Outcomes in Patients Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection After Monoclonal Antibody Therapy (MAT) with Bamlamivimab or Casirivimab-Imdevimab
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
Limited options currently exist for treatment of patients diagnosed with symptomatic coronavirus 2019 (COVID-19). Monoclonal antibody therapy (MAT) has been investigated as a therapeutic option for symptomatic COVID-19 patients in the outpatient setting at high-risk for progression to severe disease based on emergency use authorization (EUA) criteria. No published studies have compared outcomes for patients treated with different MAT for COVID-19.

Methods
This was a single-center, retrospective cohort study at The Ohio State University Wexner Medical Center to compare COVID-19-related emergency room (ER) visits, admissions, and mortality at 30 days after MAT infusion for adult patients with symptomatic SARS-CoV-2 between November 16, 2020 and February 2, 2021 who received bamlanivimab versus those who received casirivimab-imdevimab. Statistical analysis used logistic regression analysis to determine the odds ratio (OR) to evaluate the relationship between patient characteristics, MAT, and outcomes.

Results
The cohort included 943 patients with SARS-CoV-2 who received MAT, including 658 patients who received bamlanivimab and 285 who received casirivimab-imdevimab. Outcome results between patients who received bamlanivimab and casirivimab-imdevimab showed no statistically significant difference seen in the number of COVID-19 related ER visits (3.2% vs 3.5%, p = 0.80), hospital admissions (4.6% vs 2.8%, p = 0.21), or mortality (0.5% vs 0.7%, p = 0.63). Multivariate analysis showed no statistically significant difference in outcomes between the groups when accounting for potential confounders. As reflected in the Table, chronic lymphocytic leukemia (CLL), gender, and asthma were associated with increased COVID-19 related ER visit within 30 days of infusion and age, chronic obstructive pulmonary disease, CLL, and lupus were associated with increased risk for COVID-19 related admission within 30 days of infusion. Age and obesity with body mass index greater than 35 mg/kg2 were associated with increased risk for COVID-19 related mortality at 30 days.

Conclusion
COVID-19 related outcomes were similar when comparing patients with COVID-19 treated with bamlanivimab versus those treated with casirivimab-imdevimab.

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)
537. Implementation of a Workflow for COVID-19 Monoclonal Antibody Infusions at a Veterans Affairs Medical Center
Authors: Patel Pratish C , Adenew Ayne , McKnight Angela , Jeng Kevin , Liappis Angelike P 
Published: December 2021

Abstract

Background
In the setting of the global pandemic due to COVID-19, high-risk patients with mild to moderate disease were identified as a group who would benefit from COVID-19 monoclonal antibody (mAB) treatment to mitigate progression to severe disease or hospitalization. The U.S. Food and Drug Administration (FDA), under Emergency Use Authorizations (EUA) approved multiple COVID-19 mAB therapies with specific criteria for eligibility of candidates, documentation of discussion with patients, and reporting of all errors and serious adverse events.

Methods
A cross discipline working group implemented a mAB clinic at complexity level 1a VA Medical Center in metropolitan Washington, D.C. through collaboration of personnel committed to patient care. The team successfully persuaded hospital leadership to provide space and leveraged technologies for rapid communication and dissemination of education. A stewardship driven medical center wide surveillance system rapidly identified outpatients for screening; primary care and ED providers were engaged through various electronic methods of education, including email, web-based team communication, intranet webpages and other electronic modalities. Within the EMR, an order panel was implemented to assure that the key requirements of the EUA were met and the provider was guided to the appropriate mAB, nursing, and PRN rescue medication orders.

Results
Of over 17,000 COVID-PCR tests were performed at our medical center, 198 outpatients were screened and 16 received COVID-19 mAB infusions between January 2, 2021 to May 31, 2021. One patient experienced a reaction requiring the infusion to be stopped and supportive medications to be administered; there were no long-term sequalae reported as a result of this event.

Conclusion
A multidisciplinary collaboration is well suited to implement innovative processes and policies for novel therapies in the middle of a pandemic. An agile workflow, regular communications between members of the workgroup, and commitment of institutional leadership helped facilitate the changes necessary to provide our patients the opportunity to receive potentially life-saving therapies.

Disclosures
All Authors: No reported disclosures
539. Impact of Corticosteroids when Combined with Tocilizumab or Remdesivir for the Treatment of Severe SARS-CoV-2
Authors: Rosati Michael , Vyas Nikunj M , Hou Cindy 
Published: December 2021

Abstract

Background
Tocilizumab (TCZ) and remdesivir (RDV) have both shown benefit for patients with SARS-CoV-2. However, there have been no head to head studies comparing the efficacy of the two therapies. The purpose of this study is to compare clinical outcomes of patients who have received corticosteroids (CS) along with TCZ or RDV.

Methods
This is an IRB approved retrospective observational study completed in a three hospital health system in New Jersey. Patients were included if age was ≥ 18, admitted with SARS-CoV2 infection requiring oxygen. Patients were stratified into two treatment arms; CS + TCZ and CS + RDV. The primary objective was to compare all-cause inpatient mortality (ACIM) based on oxygenation status; nasal cannula (NC), high-flow nasal cannula (HFNC), and invasive mechanical intubation (IMV). Secondary objectives was a snapshot analysis with a focus on clinical improvement (CI) defined as improvement in clinical ordinal scale by 2 or more at end of stay. Additional endpoint included progression to IMV after therapy initiation.

Results
There were total of 1053 patients included (123 in the CS+TCZ arm, 930 in the CS+RDV arm). Oxygen requirements were as follows: In the CS+TCZ arm (NC n=57, HFNC n=26, IMV n=40), and the RD+CS arm (NC n=669, HFN n=159, and IMV n=102). Results from the primary endpoints can be found in Table 1. No statistically significant differences were observed between the two treatment arms. For the secondary objective there were 214 patients included (70 in the CS+TCZ arm and 105 in the CS+RDV arm). For patients receiving NC, no difference seen in CI between two treatment arms (81.4% CS+RDV vs. 81.5% CS+TCZ). In HFNC group more patients in the CS+TCZ group observed CI compared to CS+RDV (68.8% vs. 40%). Less patients requiring HFNC progressed to IMV in CS+TCZ group (25%) compared to CS+RDV (40%).

Conclusion
No statistical difference in ACIM was detected between the two treatment arms regardless of baseline oxygenation requirements. There was a trend towards lower ACIM for IMV patients in the CS+TCZ arm compared to the CS+RDV arm. More patients experienced CI in CS+TCZ group compared to CS+RDV in HFNC group. Less HFNC patients also required new IMV in the CS+TCZ arm. Larger studies need to be performed to evaluate a true statistical difference between the two treatment arms.

Disclosures
All Authors: No reported disclosures
540. Does Remdesivir Impact the Clinical Outcome of Patients with COVID 19 Infection?
Authors: Gunasekaran Karthik , John Jisha S , Alexander Hanna , Gracelin Naveena , Samuel Prasanna , Rupali Priscilla 
Published: December 2021

Abstract

Background
Remdesivir (RDV), was included for the treatment of mild to moderate COVID-19 since July 2020 in our institution, following the initial results from ACTT-1 interim analysis report. With the adoption of RDV, there seems to be anecdotal evidence of efficacy as evidenced by early fever defervescence, quick recovery when on oxygen with decreased need for ventilation and ICU care. We aimed to study the impact of RDV on clinical outcomes among patients with moderate to severe COVID –19.

Methods
Nested case control study in the cohort of consecutive patients with moderate to severe COVID – 19. Cases were patients initiated on RDV and age and sex- matched controls who did not receive RDV were included. The primary outcome was in-hospital mortality. Secondary outcomes were, duration of hospital stay, need for ICU, duration of oxygen therapy and need for ventilation.

Results
A total of 926 consecutive patients with COVID – 19 were included, among which 411 patients were cases and 515 controls. The mean age of the cohort was 57.05±13.5 years, with male preponderance (75.92%). The overall in-hospital mortality was 22.46%(n=208). On comparison between cases and controls there was no statistically significant difference with respect to primary outcome [22.54% vs. 20.78%, (p value: 0.17)]. Progression to non-invasive ventilation (NIV) was higher among the controls [24.09% vs. 40.78% (p value: &lt; 0.001*)]. Progression to invasive ventilation was also higher among the controls [5.35% vs. 9.71% (p value: 0.014*)]. In subgroup analysis among critically ill patients, the use of RDV showed decrease in mortality (OR 0.32 95% CI; 0.13 – 0.75 p value – 0.009*).

Conclusion
RDV did not decrease the in-hospital mortality among moderate to severe COVID – 19. However, there seems to be a significant reduction in mortality in critically ill patients.

Disclosures
All Authors: No reported disclosures
541. Comparing Patients with Severe COVID-19 Who Improve to the Point of Discharge Following an Abbreviated Course (&lt; 5 Days) of Remdesivir (RDV) Versus a Standard Course (≥5 Days)
Authors: Pham Huan , Chen Qiaoling , Li Aldon , Baghban Adam , Cheruvanky Anita , Faiad Graciela 
Published: December 2021

Abstract

Background
The COVID-19 pandemic has negatively affected our healthcare system. Our hospitals have reached maximum capacity on several occasions. Because of the need to make beds available to new patients, some patients with severe COVID-19 who were on low flow O2 supplementation have been discharged home prior to completion of the standard (≥ 5-day) RDV course. To date, data are limited regarding clinical outcomes on these patients. Because of this, we conducted a retrospective study to assess the clinical outcomes of patients who received an abbreviated treatment course of RDV.

Methods
Retrospective (chart review) study

Subject population
All nonpregnant adult patients who were hospitalized at Kaiser Permanente Riverside Medical Center and Kaiser Permanente Moreno Valley Medical Center in 2020 with severe COVID-19 who required low flow O2 supplement during hospitalization who received RDV and discharged from hospital alive. Severe COVID-19 = positive SARS-CoV-2 PCR + evidence of lung involvement on lung imaging (X-ray or CT) + O2 saturation ≤ 94% on room air or requirement of O2 supplement.

Inclusion criteria
Age ≥ 18 years; Hospitalized with severe COVID-19; Given RDV

Exclusion criteria
Pregnancy; O2 requirement &gt; 6 L including high flow and mechanical ventilation (noninvasive or invasive); discontinuation of RDV due to adverse effects
Figure 1. Patient Section.

Results
Mortality rate: no difference (2.1% vs 1.8%, p=0.84). 30 day post-discharge ED visit: twice more likely in the abbreviated RDV group as compared to the group receiving the standard duration (16.1% vs 8.5%, p=0.03). 30 day readmission: almost 10 times more likely in the abbreviated RDV group as compared to the group receiving the standard duration (11.9% vs 1.2%, p=&lt; 0.001).
Table 1. Patient's Characteristics

Table 2. Clinical Outcomes. *8 Patients Who Died Within 30-Day from Discharge Were Excluded

Conclusion
Though there is no difference in 30 day mortality rate, the patients who received the abbreviated RDV course are twice more likely to have ER visit and 10 times more likely to have readmission within 30 day post discharge despite more patients in the abbreviated course receiving steroids. The findings suggest that completing an at least 5-day course of RDV may be beneficial even in patients who demonstrate a clinical response earlier in course.

Disclosures
All Authors: No reported disclosures
542. Use of Bamlanivimab in Cancer Patients with Mild-to-Moderate COVID-19
Authors: Brock Patricia , Dagher Hiba , Wechsler Adriana H , Lipe Demis N , Chaftari Patrick , Chaftari Anne-Marie , Gaeta Maria S , Johnson Tami N , Coussirat Daniel J , Aitken Samuel L , Aitken Samuel L , Jiang Ying , Malek Alexandre , Hachem Ray Y , Raad Issam I 
Published: December 2021

Abstract

Background
Bamlanivimab is a monoclonal antibody that was granted an emergency use authorization by the US Food and Drug Administration in November 2020 for patients with mild to moderate coronavirus disease 2019 (COVID-19). It initially showed promising results with decreasing hospitalizations and return emergency department visits in immunocompetent patients. We evaluated the role of bamlanivimab in the cancer patient population.

Methods
We conducted a retrospective matched study of all cancer patients diagnosed with mild to moderate COVID-19 who received bamlanivimab in our acute cancer care center (ACCC) from December 2020 to February 2021. These patients were compared to a control group of cancer patients who presented to our ACCC and were diagnosed with mild to moderate COVID-19 from March to November 2020 before the introduction of bamlanivimab. Control patients were matched by age and underlying malignancy. All patients had a baseline oxygen saturation ≥ 94% and an absolute neutrophil count &gt; 500 mm3. Demographics, clinical characteristics, and outcome that included COVID-related admissions, oxygen desaturation, ICU admission and 30-day mortality were compared in both groups.

Results
A total of 108 patients were analyzed with 54 patients in each group, of which 59% consisted of hematologic malignancies, and 33% were ≥ 65 years. The presenting symptoms were similar in both groups and mainly consisted of cough, fever, and dyspnea. Patients who received bamlanivimab were less likely to be admitted to the hospital (24% vs. 91%; p&lt; 0.0001), experience oxygen desaturation &lt; 94% during follow-up (11% vs 44%; p=0.0001), require oxygen supplement (7% vs. 44%; p&lt; 0.0001), or be admitted to the ICU (4% vs 15%; p=0.046). No 30-day mortality was observed in the bamlanivimab group with 2 (4%) occurring in the control group. However, the difference was not significant.

Conclusion
Bamlanivimab decreased hospital and ICU admissions in cancer patients. In addition, bamlanivimab reduced oxygen requirement and the risk of hypoxia and progression to severe disease in this patient population.

Disclosures
Samuel L. Aitken, PharmD, MPH, BCIDP, Melinta Therapeutoics (Individual(s) Involved: Self): Consultant, Grant/Research Support