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Article ; Online: Computer-Based Patient Bias and Misconduct Training Impact on Reports to Incident Learning System.

Wilker, Caroline G / Stockham, Abigail L / Houge, Benjamin J / Stevens, Sheila K / Munson, Karee A / Mueller, Paul S

Mayo Clinic proceedings. Innovations, quality & outcomes

2021 Volume 5, Issue 6, Page(s) 1075–1080

Abstract: Objective: To assess the effect of computer-based training (CBT) and leadership communication on incident learning system reports pertaining to institutional policy that targets biased, prejudiced, and racist behaviors of patients and visitors toward ... ...

Abstract	Objective: To assess the effect of computer-based training (CBT) and leadership communication on incident learning system reports pertaining to institutional policy that targets biased, prejudiced, and racist behaviors of patients and visitors toward health care employees. Patients and methods: Mayo Clinic developed a CBT module and comprehensive communication strategy to educate staff on the Patient and Visitor Conduct Policy. Additional goals were to demonstrate leadership endorsement and support of the policy, teach how to report an incident, and facilitate how policy enforcement might occur. Using descriptive statistics, we compared the reporting data before and after the intervention. Results: Participants were 13,980 employees in 68 clinics and 18 hospitals in the US Midwest. Bias and misconduct incidents entered in the incident reporting system increased 312% (n=140 incidents; preintervention, n=34) in the quarter (ie, 3 months) immediately after intervention. The number of incidents in the next quarter stayed increased (234%; n=114) compared with the preintervention number. Secondary debriefing with employees showed the value of the education and the importance of leadership support at the highest level to facilitate comfort in policy enforcement. Conclusion: Institutional policy that targets biased, prejudiced, and racist behaviors of patients toward employees in a health care setting can be augmented with employee education and leadership support to facilitate change. The CBT, paired with a robust communication plan and active leadership endorsement and engagement, resulted in increased reporting of biased, prejudiced, and racist behaviors of patients.
Language	English
Publishing date	2021-11-14
Publishing country	Netherlands
Document type	Journal Article
ISSN	2542-4548
ISSN (online)	2542-4548
DOI	10.1016/j.mayocpiqo.2021.08.013
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Article ; Online: Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities.

Bierle, Dennis M / Ganesh, Ravindra / Tulledge-Scheitel, Sidna / Hanson, Sara N / Arndt, Lori L / Wilker, Caroline G / Razonable, Raymund R

The Journal of infectious diseases

2021 Volume 225, Issue 4, Page(s) 598–602

Abstract: Background: Breakthrough coronavirus disease 2019 (COVID-19) may occur in fully vaccinated persons.: Methods: We assessed the clinical outcomes of breakthrough COVID-19 in fully vaccinated individuals.: Results: In this cohort of 1395 persons ( ... ...

Abstract	Background: Breakthrough coronavirus disease 2019 (COVID-19) may occur in fully vaccinated persons. Methods: We assessed the clinical outcomes of breakthrough COVID-19 in fully vaccinated individuals. Results: In this cohort of 1395 persons (mean age, 54.3 years; 60% female; median body mass index, 30.7) who developed breakthrough COVID- 19, there were 107 (7.7%) who required hospitalization by day 28. Hospitalization was significantly associated with the number of medical comorbidities. Antispike monoclonal antibody treatment was significantly associated with a lower risk of hospitalization (odds ratio, 0.227; 95% confidence interval, 0.128-0.403; P < .001). The number needed to treat (NNT) to prevent 1 hospitalization was 225 among the lowest risk patient group compared with NNT of 4 among those with highest numbers of medical comorbidity. Conclusions: Monoclonal antibody treatment is associated with reduced hospitalization in vaccinated high-risk persons with mild to moderate COVID-19.
MeSH term(s)	Antibodies, Monoclonal/therapeutic use ; COVID-19/therapy ; COVID-19 Vaccines ; Comorbidity ; Female ; Humans ; Male ; Middle Aged ; Risk Factors ; Vaccination
Chemical Substances	Antibodies, Monoclonal ; COVID-19 Vaccines
Language	English
Publishing date	2021-10-29
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiab570
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Article ; Online: Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities

Bierle, Dennis M. / Ganesh, Ravindra / Tulledge-Scheitel, Sidna / Hanson, Sara N. / Arndt, Lori L. / Wilker, Caroline G. / Razonable, Raymund R.

medRxiv

Abstract: Abstract Breakthrough COVID-19 may occur in fully vaccinated persons. In this cohort of 1395 persons (mean age, 54.3 years; 60% female; median body mass index, 30.7) who developed breakthrough COVID-19, there were 107 (7.7%) who required hospitalization ... ...

Abstract	Abstract Breakthrough COVID-19 may occur in fully vaccinated persons. In this cohort of 1395 persons (mean age, 54.3 years; 60% female; median body mass index, 30.7) who developed breakthrough COVID-19, there were 107 (7.7%) who required hospitalization by day 28. Hospitalization was significantly associated with the number of medical comorbidities. Anti-spike monoclonal antibody treatment was significantly associated with a lower risk of hospitalization (Odds Ratio: 0.227; 95% confidence interval, 0.128 - 0.403; p<0.001). The number needed to treat to prevent one hospitalization was 225 among the lowest-risk patient group compared to 4 among the groups with highest numbers of medical comorbidity.
Keywords	covid19
Language	English
Publishing date	2021-10-20
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2021.10.19.21265222
Database	COVID19

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Article ; Online: Influence of Social and Cultural Factors on the Decision to Consent for Monoclonal Antibody Treatment among High-Risk Patients with Mild-Moderate COVID-19.

Bierle, Dennis M / Ganesh, Ravindra / Wilker, Caroline G / Hanson, Sara N / Moehnke, Darcie E / Jackson, Tammy A / Ramar, Priya / Rosedahl, Jordan K / Philpot, Lindsey M / Razonable, Raymund R

Journal of primary care & community health

2021 Volume 12, Page(s) 21501327211019282

Abstract: Background: The clinical outcomes of patients who decline anti-spike monoclonal antibody therapies for coronavirus disease-2019 (COVID-19) is not known. Factors associated with the decision to accept or decline the offer for anti-spike monoclonal ... ...

Abstract	Background: The clinical outcomes of patients who decline anti-spike monoclonal antibody therapies for coronavirus disease-2019 (COVID-19) is not known. Factors associated with the decision to accept or decline the offer for anti-spike monoclonal antibody therapies are not established. This study aimed to identify factors impacting the decision to consent for monoclonal antibody therapies and assess the differences in clinical outcomes of patients who accepted compared to those who declined these therapies. Methods: This retrospective cohort study enrolled 2820 adult patients who were offered monoclonal antibody therapies, bamlanivimab and casirivimab-imdevimab, for COVID-19 at Mayo Clinic in the Midwest between 11/19/2020 and 12/31/2020. The primary endpoint is the decision to accept or decline monoclonal antibody treatment. Secondary endpoints were patient-level factors that could have impacted the decision to accept treatment (age, gender, race, ethnicity, primary language spoken, and medical comorbidities). The main clinical endpoint was hospitalization within 28 days of COVID-19 diagnosis. Results: 59.1% (n = 1669) chose to accept monoclonal antibody therapy, and 40.9% (n = 1151) chose to decline the offer for treatment. Patients were more likely to accept treatment if they were non-Hispanic White, English speaking, identified a spouse or life partner, had a religious affiliation, and possessed more medical comorbidities. Overall, 28-day hospitalization rate was 2.6% (n = 72/2820) and was higher among those who declined (3.3%) than those who accepted monoclonal antibody therapy (2.0%; Rate Ratio = 0.62, 95% Confidence Interval, 0.39-0.98). Conclusions: Despite having more comorbidities, patients who accepted monoclonal antibody treatments had a lower rate of hospitalization compared to patients who declined treatment. Several social and cultural factors were associated with the decision to decline therapy, including race, language, ethnicity, and lack of social support. These findings can inform public health efforts to reduce social disparities in the treatment of COVID-19 and increase utilization of monoclonal antibody therapies in high risk populations.
MeSH term(s)	Adult ; Antibodies, Monoclonal/therapeutic use ; COVID-19 ; COVID-19 Testing ; Humans ; Informed Consent ; Retrospective Studies ; SARS-CoV-2
Chemical Substances	Antibodies, Monoclonal
Language	English
Publishing date	2021-05-25
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2550221-9
ISSN	2150-1327 ; 2150-1319
ISSN (online)	2150-1327
ISSN	2150-1319
DOI	10.1177/21501327211019282
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Article ; Online: Effectiveness of Monoclonal Antibodies in Preventing Severe COVID-19 With Emergence of the Delta Variant.

O'Horo, John C / Challener, Douglas W / Speicher, Leigh / Bosch, Wendelyn / Seville, Maria Teresa / Bierle, Dennis M / Ganesh, Ravindra / Wilker, Caroline G / Arndt, Richard F / Arndt, Lori L / Tulledge-Scheitel, Sidna M / Hanson, Sara N / Razonable, Raymund R

Mayo Clinic proceedings

2021 Volume 97, Issue 2, Page(s) 327–332

Abstract: Anti-spike monoclonal antibodies have proven invaluable in preventing severe outcomes from COVID-19, including hospitalization and death. The rise of the SARS-CoV-2 delta variant begs the question of whether monoclonal antibodies maintain similar ... ...

Abstract	Anti-spike monoclonal antibodies have proven invaluable in preventing severe outcomes from COVID-19, including hospitalization and death. The rise of the SARS-CoV-2 delta variant begs the question of whether monoclonal antibodies maintain similar efficacy now as they had when the alpha and beta variants predominated, when they were first assessed and approved. We used a retrospective cohort to compare rates of severe outcomes in an epoch in which alpha and beta were predominant compared with delta. A total of 5356 patients were infused during the alpha/beta variant-predominant (n=4874) and delta variant-predominant (n=482) era. Overall, odds of severe infection were 3.0% of patients in the alpha/beta-predominant era compared with 4.9% in the delta-predominant cohort. The unadjusted odds ratio (OR) was higher for severe disease in the delta era (OR, 1.67; 95% CI, 0.96 to 2.89), particularly when adjusted for Charlson Comorbidity Index (adjusted OR, 2.04; 95% CI, 1.30 to 3.08). The higher odds of severe infection could be due to a more virulent delta variant, although the possibility of decreased anti-spike monoclonal antibody effectiveness in the clinical setting cannot be excluded. Research into the most effective strategies for using and improving anti-spike monoclonals for the treatment of emerging variants is warranted.
MeSH term(s)	Aged ; Antibodies, Monoclonal/therapeutic use ; Cohort Studies ; Female ; Humans ; Immunologic Factors/therapeutic use ; Male ; Middle Aged ; Patient Acuity ; Retrospective Studies ; SARS-CoV-2/immunology ; United States/epidemiology ; COVID-19 Drug Treatment
Chemical Substances	Antibodies, Monoclonal ; Immunologic Factors
Language	English
Publishing date	2021-12-16
Publishing country	England
Document type	Journal Article
ZDB-ID	124027-4
ISSN	1942-5546 ; 0025-6196
ISSN (online)	1942-5546
ISSN	0025-6196
DOI	10.1016/j.mayocp.2021.12.002
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Article ; Online: Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19.

The Journal of clinical investigation

2021 Volume 131, Issue 19

Abstract: BACKGROUNDClinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) are needed.METHODS2335 Patients who received single-dose bamlanivimab infusion between November 12, 2020, ... ...

Abstract	BACKGROUNDClinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) are needed.METHODS2335 Patients who received single-dose bamlanivimab infusion between November 12, 2020, and February 17, 2021, were compared with a propensity-matched control of 2335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states. The primary outcome was the rate of hospitalization at days 14, 21, and 28.RESULTSThe median age of the population was 63 years; 47.3% of the bamlanivimab-treated cohort were 65 years or more; 49.3% were female and 50.7% were male. High-risk characteristics included hypertension (54.2%), BMI greater than or equal to 35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs. 3.5%; risk ratio [RR], 0.41), 21 (1.9% vs. 3.9%; RR, 0.49), and 28 (2.5% vs. 3.9%; RR, 0.63). Secondary exploratory outcomes included lower intensive care unit (ICU) admission rates at days 14 (0.14% vs. 1%; RR, 0.14), 21 (0.25% vs.1%; RR, 0.25), and 28 (0.56% vs.1.1%; RR. 0.51) and lower all-cause mortality at days 14 (0% vs. 0.33%), 21 (0.05% vs. 0.4%; RR,0.13), and 28 (0.11% vs. 0.44%; RR, 0.26). Adverse events were uncommon with bamlanivimab, occurring in 19 of 2355 patients, and were most commonly fever (n = 6), nausea (n = 5), and lightheadedness (n = 3).CONCLUSIONSAmong high-risk patients with mild to moderate COVID-19, treatment with bamlanivimab was associated with a statistically significant lower rate of hospitalization, ICU admission, and mortality compared with usual care.FUNDINGMayo Clinic.
MeSH term(s)	Administration, Intravenous ; Adult ; Aged ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; COVID-19/metabolism ; COVID-19/mortality ; Disease-Free Survival ; Female ; Hospitalization ; Humans ; Intensive Care Units ; Male ; Middle Aged ; Risk Factors ; SARS-CoV-2/metabolism ; Survival Rate ; COVID-19 Drug Treatment
Chemical Substances	Antibodies, Monoclonal, Humanized ; bamlanivimab (45I6OFJ8QH)
Language	English
Publishing date	2021-08-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	3067-3
ISSN	1558-8238 ; 0021-9738
ISSN (online)	1558-8238
ISSN	0021-9738
DOI	10.1172/JCI151697
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Article: Association of Intravenous Bamlanivimab Use with Reduced Hospitalization, Intensive Care Unit Admission, and Mortality in Patients with Mild to Moderate COVID-19.

medRxiv : the preprint server for health sciences

2021

Abstract: Background: Clinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed.: Methods: 2,335 patients who received single-dose bamlanivimab infusion between November ... ...

Abstract	Background: Clinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed. Methods: 2,335 patients who received single-dose bamlanivimab infusion between November 12, 2020 to February 17, 2021 were compared with a propensity-matched control of 2,335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states. The primary outcome was the rate of hospitalization at days 14, 21 and 28. Results: The median age of the population was 63; 47.3% of the bamlanivimab-treated cohort were ≥65 years; 49.3% were female. High-risk characteristics included hypertension (54.2%), body mass index ≥35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs 3.5%; Odds Ratio [OR], 0.38), 21 (1.9% vs 3.9%; OR, 0.46), and 28 (2.5% vs 3.9%; OR, 0.61). Secondary exploratory outcomes included lower intensive care unit admission rates at days 14 (0.14% vs 1%; OR, 0.12), 21 (0.25% vs 1%; OR: 0.24) and 28 (0.56% vs 1.1%; OR: 0.52), and lower all-cause mortality at days 14 (0% vs 0.33%), 21 (0.05% vs 0.4%; OR,0.08) and 28 (0.11% vs 0.44%; OR, 0.01). Adverse events were uncommon with bamlanivimab, occurring in 19/2355, most commonly fever (n=6), nausea (n=5), and lightheadedness (n=3). Conclusions: Among high-risk patients with mild to moderate COVID-19, treatment with bamlanivimab was associated with a statistically significant lower rate of hospitalization compared with usual care. Funding: Mayo Clinic.
Language	English
Publishing date	2021-05-25
Publishing country	United States
Document type	Preprint
DOI	10.1101/2021.05.23.21257670
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Article ; Online: Casirivimab-Imdevimab treatment is associated with reduced rates of hospitalization among high-risk patients with mild to moderate coronavirus disease-19.

Razonable, Raymund R / Pawlowski, Colin / O'Horo, John C / Arndt, Lori L / Arndt, Richard / Bierle, Dennis M / Borgen, Molly Destro / Hanson, Sara N / Hedin, Michelle C / Lenehan, Patrick / Puranik, Arjun / Seville, Maria T / Speicher, Leigh L / Tulledge-Scheitel, Sidna M / Venkatakrishnan, A J / Wilker, Caroline G / Badley, Andrew D / Ganesh, Ravindra

EClinicalMedicine

2021 Volume 40, Page(s) 101102

Abstract: Background: Real-world clinical data to support the use of casirivimab-imdevimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed. This study aimed to assess the outcomes of casirivimab-imdevimab ... ...

Abstract	Background: Real-world clinical data to support the use of casirivimab-imdevimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed. This study aimed to assess the outcomes of casirivimab-imdevimab treatment of mild to moderate COVID-19. Methods: A retrospective cohort of 696 patients who received casirivimab-imdevimab between December 4, 2020 and April 9, 2021 was compared to a propensity-matched control of 696 untreated patients with mild to moderate COVID-19 at Mayo Clinic sites in Arizona, Florida, Minnesota, and Wisconsin. Primary outcome was rate of hospitalization at days 14, 21 and 28 after infusion. Findings: The median age of the antibody-treated cohort was 63 years (interquartile range, 52-71); 45·5% were ≥65 years old; 51.4% were female. High-risk characteristics were hypertension (52.4%), body mass index ≥35 (31.0%), diabetes mellitus (24.6%), chronic lung disease (22.1%), chronic renal disease (11.4%), congestive heart failure (6.6%), and compromised immune function (6.7%). Compared to the propensity-matched untreated control, patients who received casirivimab-imdevimab had significantly lower all-cause hospitalization rates at day 14 (1.3% vs 3.3%; Absolute Difference: 2.0%; 95% confidence interval (CI): 0.5-3.7%), day 21 (1.3% vs 4.2%; Absolute Difference: 2.9%; 95% CI: 1.2-4.7%), and day 28 (1.6% vs 4.8%; Absolute Difference: 3.2%; 95% CI: 1.4-5.1%). Rates of intensive care unit admission and mortality at days 14, 21 and 28 were similarly low for antibody-treated and untreated groups. Interpretation: Among high-risk patients with mild to moderate COVID-19, casirivimab-imdevimab treatment was associated with a significantly lower rate of hospitalization. Funding: Mayo Clinic.
Language	English
Publishing date	2021-08-30
Publishing country	England
Document type	Journal Article
ISSN	2589-5370
ISSN (online)	2589-5370
DOI	10.1016/j.eclinm.2021.101102
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Article ; Online: Real-World Clinical Outcomes of Bamlanivimab and Casirivimab-Imdevimab Among High-Risk Patients With Mild to Moderate Coronavirus Disease 2019.

Ganesh, Ravindra / Philpot, Lindsey M / Bierle, Dennis M / Anderson, Ryan J / Arndt, Lori L / Arndt, Richard F / Culbertson, Tracy L / Destro Borgen, Molly J / Hanson, Sara N / Kennedy, Brian D / Kottke, Brian B / Larsen, Jennifer J / Ramar, Priya / Rosedahl, Jordan K / Seville, Maria Teresa / Speicher, Leigh L / Tulledge-Scheitel, Sidna M / Wilker, Caroline G / Razonable, Raymund R

The Journal of infectious diseases

2021 Volume 224, Issue 8, Page(s) 1278–1286

Abstract: Background: Bamlanivimab and casirivimab-imdevimab are authorized for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in high-risk patients. We compared the outcomes of patients who received these therapies to identify factors ... ...

Abstract	Background: Bamlanivimab and casirivimab-imdevimab are authorized for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in high-risk patients. We compared the outcomes of patients who received these therapies to identify factors associated with hospitalization and other clinical outcomes. Methods: Adult patients who received monoclonal antibody from 19 November 2020 to 11 February 2021 were selected and divided into those who received bamlanivimab (n = 2747) and casirivimab-imdevimab (n = 849). The 28-day all-cause and COVID-19-related hospitalizations were compared between the groups. Results: The population included 3596 patients; the median age was 62 years, and 50% were female. All had ≥1 medical comorbidity; 55% had multiple comorbidities. All-cause and COVID-19-related hospitalization rates at 28 days were 3.98% and 2.56%, respectively. After adjusting for medical comorbidities, there was no significant difference in all-cause and COVID-19-related hospitalization rates between bamlanivimab and casirivimab-imdevimab (adjusted hazard ratios [95% confidence interval], 1.4 [.9-2.2] and 1.6 [.8-2.7], respectively). Chronic kidney, respiratory and cardiovascular diseases, and immunocompromised status were associated with higher likelihood of hospitalization. Conclusions: This observational study on the use of bamlanivimab and casirivimab-imdevimab in high-risk patients showed similarly low rates of hospitalization. The number and type of medical comorbidities are associated with hospitalizations after monoclonal antibody treatment.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized/therapeutic use ; COVID-19/diagnosis ; COVID-19/drug therapy ; COVID-19/epidemiology ; Drug Combinations ; Female ; Hospitalization/statistics & numerical data ; Humans ; Male ; Middle Aged ; Multimorbidity ; Retrospective Studies ; Risk Factors ; SARS-CoV-2/isolation & purification ; Severity of Illness Index ; Treatment Outcome ; Young Adult
Chemical Substances	Antibodies, Monoclonal, Humanized ; Drug Combinations ; casirivimab and imdevimab drug combination ; bamlanivimab (45I6OFJ8QH)
Language	English
Publishing date	2021-07-19
Publishing country	United States
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiab377
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Article ; Online: Association of Intravenous Bamlanivimab Use with Reduced Hospitalization, Intensive Care Unit Admission, and Mortality in Patients with Mild to Moderate COVID-19

medRxiv

Abstract: Background: Clinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed. Methods: 2,335 patients who received single-dose bamlanivimab infusion between November 12, ... ...

Abstract	Background: Clinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed. Methods: 2,335 patients who received single-dose bamlanivimab infusion between November 12, 2020 to February 17, 2021 were compared with a propensity-matched control of 2,335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states. The primary outcome was the rate of hospitalization at days 14, 21 and 28. Results: The median age of the population was 63; 47.3% of the bamlanivimab-treated cohort were ≥65 years; 49.3% were female. High-risk characteristics included hypertension (54.2%), body mass index ≥35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs 3.5%; Odds Ratio [OR], 0.38), 21 (1.9% vs 3.9%; OR, 0.46), and 28 (2.5% vs 3.9%; OR, 0.61). Secondary exploratory outcomes included lower intensive care unit admission rates at days 14 (0.14% vs 1%; OR, 0.12), 21 (0.25% vs 1%; OR: 0.24) and 28 (0.56% vs 1.1%; OR: 0.52), and lower all-cause mortality at days 14 (0% vs 0.33%), 21 (0.05% vs 0.4%; OR,0.08) and 28 (0.11% vs 0.44%; OR, 0.01). Adverse events were uncommon with bamlanivimab, occurring in 19/2355, most commonly fever (n=6), nausea (n=5), and lightheadedness (n=3). Conclusions: Among high-risk patients with mild to moderate COVID-19, treatment with bamlanivimab was associated with a statistically significant lower rate of hospitalization compared with usual care. Funding: Mayo Clinic.
Keywords	covid19
Language	English
Publishing date	2021-05-25
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2021.05.23.21257670
Database	COVID19

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