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1.
Curr Transplant Rep ; : 1-9, 2022 Jan 15.
Article in English | MEDLINE | ID: covidwho-1631686

ABSTRACT

Purpose of Review: Solid organ transplant recipients (SOTRs) are ideal candidates for early treatment or prevention of coronavirus disease 2019 (COVID-19) using anti-SARS-CoV-2 monoclonal antibodies because of multiple underlying medical conditions, chronic immune-suppression, sub-optimal immunogenic response to vaccination, and evolving epidemiological risks. In this article, we review pertinent challenges regarding the management of COVID-19 in SOTRs, describe the role of active and passive immunity in the treatment and prevention of COVID-19, and review real-world data regarding the use of anti-SARS-CoV-2 monoclonal antibodies in SOTRs. Recent Findings: The use of an anti-SARS-CoV-2 monoclonal antibody in high-risk solid organ transplant recipients is associated with a reduction in the risk of hospitalization, need for intensive care, and death related to COVID-19. Overall, the early experiences from a diverse population of solid organ transplant recipients who were treated with anti-spike monoclonal antibodies are encouraging with no reported acute graft injury, severe adverse events, or deaths related to COVID-19. Summary: Anti-SARS-CoV-2 antibodies are currently authorized for treatment of mild-moderate COVID-19 and post-exposure prophylaxis, including in SOTRs. Potential future uses include pre-exposure prophylaxis in certain high-risk persons and synergistic use along with emerging oral treatment options. Successful timely administration of anti-SARS-CoV-2 monoclonal antibodies requires a multidisciplinary team approach, effective communication between patients and providers, awareness of circulating viral variants, acknowledgement of various biases affecting treatment, and close monitoring for efficacy and tolerability.

4.
Open Forum Infect Dis ; 8(8): ofab383, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1584174

ABSTRACT

Background: Graduate Medical Education training programs transitioned to all-virtual recruitment in 2020. Limited data have been published regarding the consequences of this transition. We aimed to understand (1) infectious diseases (ID) fellowship programs' recruitment efforts and the effect of virtual recruitment on application and interview numbers and (2) the number of programs to which matched applicants applied and interviewed and applicants' perspectives on virtual recruitment. Methods: In 2020-2021, we surveyed all US ID fellowship program directors (PDs) and matched applicants. Descriptive data analysis was performed on quantitative survey items. Free-text responses were analyzed through a quantitative content analysis approach. Results: The PD response rate was 68/158 (43%); the applicant response rate was at least 23% (85/365). PDs reported a 27% increase in mean number of applications received and a 45% increase in mean number of applicants interviewed compared with the previous year. Applicants especially valued the online program structure information, PD program overview videos, didactic and curriculum content, and fellow testimonials and profiles. Most applicants preferred interviews lasting no more than 40 minutes and interview days lasting no more than 5 hours. Nearly all (60/64, 94%) PDs adequately learned about candidates; most (48/64, 75%) felt unable to showcase their program as well as when in-person. Most PDs (54/64, 84%) and applicants (56/73, 77%) want an option for virtual recruitment. Conclusions: Virtual recruitment enabled programs to accommodate more applicants and highlighted applicants' preferences for programs' augmented online presences and time-limited interview days. Most programs and applicants want an option for virtual interviews.

7.
Transpl Infect Dis ; 2021 Dec 21.
Article in English | MEDLINE | ID: covidwho-1583253

ABSTRACT

BACKGROUND: Solid organ transplant (SOT) recipients are at increased risk for complications from SARS-CoV-2 infection. Little is known regarding clinical course and outcomes of breakthrough COVID-19 in the fully vaccinated SOT population. We sought to describe our cohort of SOT recipients who developed symptomatic breakthrough COVID-19 after full vaccination. METHODS: We conducted a retrospective review of SOT recipients diagnosed with COVID-19 at least 14 days after completing SARS-CoV-2 vaccination. Patients were analyzed according to those presenting with mild-to-moderate and severe COVID-19, respectively. We described presenting characteristics, COVID-19 therapy, and analyzed outcomes including emergency department (ED) visits, hospitalization, and intensive care unit (ICU) admission. RESULTS: Thirty-five patients met inclusion criteria. These had a mean age of 60.8 years and kidney transplant was the most common SOT type. Five patients presented with severe COVID-19 at diagnosis, all requiring hospitalization without ICU admission. From the 30 patients who presented with mild-to-moderate infection, 28 received casirivimab-imdevimab. Four of these 28 (14.3%) had an ED visit, with one requiring hospital admission (3.4%). No patients required ICU admission. CONCLUSION: Breakthrough COVID-19 may occur in SOT recipients after full vaccination, though they appear to have acceptable outcomes. Anti-spike monoclonal antibody therapy for eligible SOT patients may have mitigated clinical progression and improved the outcomes. Further study with large cohorts is warranted. This article is protected by copyright. All rights reserved.

8.
J Infect Dis ; 2021 Nov 16.
Article in English | MEDLINE | ID: covidwho-1522223

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 (NNT) to prevent one hospitalization was 225 among the lowest-risk patient group compared to NNT of 4 among those with highest numbers of medical comorbidity.

9.
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology ; 2021.
Article in English | EuropePMC | ID: covidwho-1505319

ABSTRACT

Introduction : The impact of vaccination and casirivimab-imdevimab monoclonal antibody treatment on the clinical outcome of COVID-19 during a period of SARS-CoV-2 Delta surge is not known. Aim and Methods : All patients with COVID-19 at our facilities in the US Midwest were enrolled to assess breakthrough cases among vaccinated individuals and to compare the rates of hospitalization between casirivimab-imdevimab treated versus untreated patients. The study period occurred in July 2021 during a period dominated by the Delta variant. Results : The majority (68.1%) of 630 COVID-19 cases occurred in unvaccinated individuals. Among 403 patients eligible for monoclonal antibody treatment, the 28-day hospitalization rate was 2.6% of 112 patients who received treatment with casirivimab-imdevimab, compared to 16.6% of 291 eligible high-risk patients who did not receive casirivimab-imdevimab (Odds Ratio [OR]: 0.138, 95% confidence interval (CI): 0.0426-0.4477, p=0.001). Casirivimab-imdevimab treatment was associated with lower rates of hospitalization among the vaccinated and unvaccinated cohorts. Conclusions : During a SARS-CoV-2 Delta surge, breakthrough COVID-19 occurred among vaccinated persons, especially among those with multiple medical comorbidities. Casirivimab-imdevimab treatment was associated with significantly lower rates of hospitalization in vaccinated and unvaccinated persons.

10.
Open Forum Infect Dis ; 8(6): ofab255, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1462454

ABSTRACT

Background: Bamlanivimab and casirivimab-imdevimab are authorized for emergency use treatment of mild to moderate coronavirus disease 2019 (COVID-19) in patients at high risk for developing severe disease or hospitalization. Their safety and efficacy have not been specifically evaluated in solid organ transplant recipients. Methods: We retrospectively reviewed solid organ transplant recipients who received monoclonal antibody infusion for COVID-19 at Mayo Clinic sites through January 23, 2021. Outcomes included emergency department visit, hospitalization, mortality, and allograft rejection. Results: Seventy-three patients were treated, most commonly with bamlanivimab (75.3%). The median age was 59 years, 63% were male, and the median Charlson comorbidity index was 5. Transplant type included 41 kidney (56.2%), 13 liver (17.8%), 11 heart (15.1%), 4 kidney-pancreas (5.5%), 2 lung (2.7%), 1 heart-liver, and 1 pancreas. Eleven (15.1%) patients had an emergency department visit within 28 days of infusion, including 9 (12.3%) who were hospitalized for a median of 4 days. One patient required intensive care unit admission for a nonrespiratory complication. No patients required mechanical ventilation, died, or experienced rejection. Ten adverse events occurred, with 1 seeking medical evaluation. Hypertension was associated with hospital admission (P < .05), while other baseline characteristics were similar. The median time from symptom onset to antibody administration was 4 days in nonhospitalized patients compared with 6 days among hospitalized patients (P < .05). Conclusions: Monoclonal antibody treatment has favorable outcomes with minimal adverse effects in solid organ transplant recipients with mild to moderate COVID-19. Earlier administration of monoclonal antibody therapy appears to be more efficacious.

11.
J Clin Invest ; 131(19)2021 10 01.
Article in English | MEDLINE | ID: covidwho-1448085

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.


Subject(s)
Antibodies, Monoclonal, Humanized/administration & dosage , COVID-19 , Hospitalization , SARS-CoV-2/metabolism , Administration, Intravenous , Adult , Aged , Antibodies, Monoclonal, Humanized/adverse effects , COVID-19/drug therapy , COVID-19/metabolism , COVID-19/mortality , Disease-Free Survival , Female , Humans , Intensive Care Units , Male , Middle Aged , Risk Factors , Survival Rate
13.
EClinicalMedicine ; 40: 101102, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1377701

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.

14.
J Infect Dis ; 2021 Aug 11.
Article in English | MEDLINE | ID: covidwho-1352201
15.
Am J Transplant ; 2021 Aug 06.
Article in English | MEDLINE | ID: covidwho-1345918

ABSTRACT

Neutralizing monoclonal antibodies such as bamlanivimab emerged as promising agents in treating kidney transplant recipients with COVID-19. However, the impact of bamlanivimab on kidney allograft histology remains unknown. We report a case of a kidney transplant recipient who received bamlanivimab for COVID-19 with subsequent histologic findings of diffuse peritubular capillary C4d staining. A 33-year-old man with end-stage kidney disease secondary to hypertension who received an ABO compatible kidney from a living donor, presented for his 4-month protocol visit. He was diagnosed with COVID-19 44 days prior to his visit and had received bamlanivimab with an uneventful recovery. His 4-month surveillance biopsy showed diffuse C4d staining of the peritubular capillaries without other features of antibody-mediated rejection (ABMR). Donor-specific antibodies were negative on repeat evaluations. ABMR gene expression panel was negative. His creatinine was stable at 1.3 mg/dl, without albuminuria. Given the temporal relationship between bamlanivimab and our observations of diffuse C4d staining of the peritubular capillaries, we hypothesize that bamlanivimab might bind to angiotensin-converting enzyme 2, resulting in classical complement pathway and C4d deposition. We elected to closely monitor kidney function which has been stable at 6 months after the biopsy. In conclusion, diffuse C4d may present following bamlanivimab administration without any evidence of ABMR.

16.
J Infect Dis ; 224(8): 1278-1286, 2021 10 28.
Article in English | MEDLINE | ID: covidwho-1316825

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.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19/drug therapy , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/diagnosis , 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
17.
Am J Transplant ; 21(8): 2890-2894, 2021 08.
Article in English | MEDLINE | ID: covidwho-1297494

ABSTRACT

Current guidelines recommend deferring liver transplantation (LT) in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection until clinical improvement occurs and two PCR tests collected at least 24 hours apart are negative. We report a case of an 18-year-old, previously healthy African-American woman diagnosed with COVID-19, who presents with acute liver failure (ALF) requiring urgent LT in the context of SARS-CoV-2 polymerase chain reaction (PCR) positivity. The patient was thought to have acute Wilsonian crisis on the basis of hemolytic anemia, alkaline phosphatase:bilirubin ratio <4, AST:ALT ratio >2.2, elevated serum copper, and low uric acid, although an unusual presentation of COVID-19 causing ALF could not be excluded. After meeting criteria for status 1a listing, the patient underwent successful LT, despite ongoing SARS-CoV-2 PCR positivity. Remdesivir was given immediately posttransplant, and mycophenolate mofetil was withheld initially and the SARS-CoV-2 PCR test eventually became negative. Three months following transplantation, the patient has made a near-complete recovery. This case highlights that COVID-19 with SARS-CoV-2 PCR positivity may not be an absolute contraindication for transplantation in ALF. Criteria for patient selection and timing of LT amid the COVID-19 pandemic need to be validated in future studies.


Subject(s)
COVID-19 , Liver Failure, Acute , Liver Transplantation , Adolescent , Female , Humans , Liver Failure, Acute/etiology , Liver Failure, Acute/surgery , Liver Transplantation/adverse effects , Pandemics , Polymerase Chain Reaction , SARS-CoV-2
18.
J Prim Care Community Health ; 12: 21501327211019282, 2021.
Article in English | MEDLINE | ID: covidwho-1242235

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.


Subject(s)
Antibodies, Monoclonal , COVID-19 , Adult , Antibodies, Monoclonal/therapeutic use , COVID-19 Testing , Humans , Informed Consent , Retrospective Studies , SARS-CoV-2
19.
Mayo Clin Proc ; 96(5): 1250-1261, 2021 05.
Article in English | MEDLINE | ID: covidwho-1219872

ABSTRACT

The administration of spike monoclonal antibody treatment to patients with mild to moderate COVID-19 is very challenging. This article summarizes essential components and processes in establishing an effective spike monoclonal antibody infusion program. Rapid identification of a dedicated physical infrastructure was essential to circumvent the logistical challenges of caring for infectious patients while maintaining compliance with regulations and ensuring the safety of our personnel and other patients. Our partnerships and collaborations among multiple different specialties and disciplines enabled contributions from personnel with specific expertise in medicine, nursing, pharmacy, infection prevention and control, electronic health record (EHR) informatics, compliance, legal, medical ethics, engineering, administration, and other critical areas. Clear communication and a culture in which all roles are welcomed at the planning and operational tables are critical to the rapid development and refinement needed to adapt and thrive in providing this time-sensitive beneficial therapy. Our partnerships with leaders and providers outside our institutions, including those who care for underserved populations, have promoted equity in the access of monoclonal antibodies in our regions. Strong support from institutional leadership facilitated expedited action when needed, from a physical, personnel, and system infrastructure standpoint. Our ongoing real-time assessment and monitoring of our clinical program allowed us to improve and optimize our processes to ensure that the needs of our patients with COVID-19 in the outpatient setting are met.


Subject(s)
Antiviral Agents/administration & dosage , COVID-19 , Critical Pathways , Home Infusion Therapy , SARS-CoV-2 , Spike Glycoprotein, Coronavirus , Antibodies, Monoclonal/administration & dosage , COVID-19/epidemiology , COVID-19/therapy , Clinical Protocols , Critical Pathways/organization & administration , Critical Pathways/trends , Efficiency, Organizational , Home Infusion Therapy/methods , Home Infusion Therapy/standards , Humans , Intersectoral Collaboration , Organizational Culture , Program Development/methods , SARS-CoV-2/immunology , SARS-CoV-2/isolation & purification , Severity of Illness Index , Spike Glycoprotein, Coronavirus/antagonists & inhibitors , Spike Glycoprotein, Coronavirus/immunology , United States/epidemiology
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