Prevalence, clinical course and outcomes of COVID-19 in peritoneal dialysis (PD) patients: a single-center experience.

INTRODUCTION: There are limited data on the effects of COVID-19 on peritoneal dialysis (PD) patients. This study aimed to describe the impact of COVID-19 on the PD population. METHODS: A monocentric retrospective observational study was conducted on 146 consecutive PD patients followed from January 2020 to March 2022 at the University Hospital of Modena, Italy. RESULTS: Twenty-seven (18.4%) PD patients experienced 29 episodes of SARS-CoV-2 infection, corresponding to an incidence rate of 0.16 episodes/patient-year. Median age of COVID-19 patients was 60.4 (interquartile range [IQR] 50.2-66.5) years. In unvaccinated patients (n. 9), COVID-19 was always symptomatic and manifested with fever (100%) and cough (77.7%). COVID-19 caused hospital admission of three (33.3%) patients and two (22.2%) died of septic shock. COVID-19 was symptomatic in 83.3% of vaccinated subjects (n.18) and manifested with fever (61.1%) and cough (55.6%). Hospital admission occurred in 27.8% of the subjects but all were discharged home. Median SARS-CoV-2 shedding was 32 and 26 days in the unvaccinated and vaccinated groups, respectively. At the end of the follow-up, COVID-19 triggered the shift from PD to HD in two subjects without affecting the residual renal function of the remaining patients. Overall, COVID-19 caused an excess death of 22.2%. COVID-19 vaccination refusal accounted for only 1.6% in this cohort of patients. CONCLUSION: COVID-19 incident rate was 0.16 episodes/patient-year in the PD population. About one-third of the patients were hospitalized for severe infection. Fatal outcome occurred in two (7.4%) unvaccinated patients. A low vaccination refusal rate was observed in this population.

Ethical challenges in managing unvaccinated patients receiving chronic in-centre haemodialysis.

Insufficient vaccine coverage and dominance of the more transmissible severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants are the leading causes of the continued spread of coronavirus disease 2019 (COVID-19) worldwide. To curb the surge in infections, COVID-19 vaccination has been advocated as a priority measure, especially for frail populations and people at high risk of exposure. Patients on in-centre maintenance haemodialysis (HD) embody both conditions. They are at high risk of severe COVID-19 consequences due to their advanced age and weakened immune system and carry an increased risk of SARS-CoV-2 transmission within shared dialysis rooms and public vehicles. Vaccination of the entire HD population is therefore the most effective strategy to protect patients from the dire consequences of COVID-19. Unfortunately, a minority of patients still express COVID-19 vaccine hesitancy. The management of this group of patients, who have the full right to HD treatment, poses demanding problems from a patient safety perspective. The placement of unvaccinated patients within the dialysis room and the protection of all vaccinated patients are some of the most urgent problems the nephrologist faces during the COVID-19 pandemic. In light of these COVID-19-driven changes, an ethical reflection on the management of unvaccinated patients appears crucial to act responsibly and contribute to the health promotion of dialysis patients.

COVID-19 Rapid Antigen Test Screening in Patients on Hemodialysis.

Introduction: Patients receiving in-center hemodialysis are extremely vulnerable to COVID-19. It is unclear if routine screening of asymptomatic hemodialysis patients is an effective strategy to prevent COVID-19 outbreaks within the dialysis unit. Methods: We conducted a retrospective analysis of in-center hemodialysis patients who underwent bimonthly COVID-19 rapid antigen test screening from February 15th to December 26th, 2021. Nasal rapid antigen testing was performed in all asymptomatic patients. All rapid antigen-positive tests were confirmed by RT-PCR nasopharyngeal swab. Besides universal rapid antigen screening, RT-PCR testing was conducted in all symptomatic patients and contacts of COVID-19 subjects. Results: Overall, 4079 rapid antigen tests were performed in 277 hemodialysis patients on chronic hemodialysis with a mean age of 68.4 ± 14.6 years. Thirty-eight (0.9%) rapid antigen tests resulted positive. Only five (13.8%) positive-rapid antigen tests were also positive by RT-PCR testing. During the same period, 219 patients regularly screened by rapid antigen tests bimonthly underwent 442 RT-PCR nasopharyngeal swabs for clinical reasons. RT-PCR testing yielded a positive result in 13 (5.9%) patients. The time elapsed between PCR and the negative-rapid antigen test was 7.7 ± 4.6 days (range 1.8-13.9 days). At the end of the follow-up, 6.4% of the population on in-center hemodialysis contracted COVID-19, and routine rapid antigen tests detected only 5 out of 18 (27.7%) COVID-19 cases. No outbreaks of COVID-19 were identified within the dialysis unit. Conclusion: Bimonthly rapid antigen screening led to the early diagnosis of COVID-19 in less than one-third of cases. The short incubation period of the new SARS-CoV-2 variants makes bimonthly test screening inadequate for an early diagnosis of COVID-19. More frequent tests are probably necessary to improve the utility of COVID-19 nasal rapid antigen test in patients on hemodialysis.

Reactogenicity of MRNA-1273 Vaccine in Patients on Haemodialysis

BACKGROUND AND AIMS mRNA-1273 vaccine (previously known as vaccine Moderna) has shown 94.1% efficacy at preventing COVID-19 illness in the general population. Vaccine-related adverse events (AEs) were usually mild or moderate in intensity and resolved within a few days. Nevertheless, the fear of developing AEs led some patients on haemodialysis to deny vaccination or additional booster doses. No studies have been conducted to evaluate the reactogenicity of the mRNA-1273 vaccine in dialysis patients. To inform public health and clinical practice, we investigated the safety of the mRNA-1273 vaccine in a cohort of patients on haemodialysis. METHOD We conducted a retrospective analysis of in-centre haemodialysis patients without a prior COVID-19 diagnosis who underwent mRNA-1273 vaccine from 1 March to 30 April 2021. mRNA-1273 vaccine was performed in all patients without signs of ongoing infection or COVID-19 who provided written consent from 24 March to 30 April 2021. AEs occurring after the first and the second doses were collected and classified as local or systemic. RESULTS Overall, 126 patients on chronic maintenance dialysis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54.7–76) years and 53.6% of patients were aged ≥65 years (Table 1). AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%), nausea/vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%).Table 1. Demographic and clinical characteristics of haemodialysis patients who underwent RNA-1273 vaccine administrationBasal characteristicsAll patients(n = 126) Age (year)68 (54.7–6) (range)19–92 ≥ 65 years71 (56.3) Males, n (%)71 (56.31) Ethnic origin, n. (%)  Caucasian110 (87.3) African15 (11.9) Hispanic1 (0.8)Etiology of ESRD, n. (%)  Nephrosclerosis54 (42.9) Glomerulonephritis26 (20.6) Diabetes14 (11.1) ADPKD4 (3.2) Nephrotoxic4 (3.2) Pyelonephritis4 (3.2) Interstitial3 (2.4) HIVAN2 (1.6) Others10 (7.9) NA5 (4)HD treatment schedule, n (%)  3 times per week115 (91.2) 2 times per week7 (5.5) 4 times per week4 (3.1)Infectious disease, n. (%)  HBV3 (2.3) HCV3 (2.3) HIV2 (1.5)Time elapsed from the first to the second dose of vaccine, day28 (28–28)Follow-up, day68 (66–70) ESRD, end-stage renal disease;HBV, hepatitis B virus;HCV, hepatitis C virus. The rates of local AEs were similar after the first and second doses (P = .8), whereas systemic AEs occurred more frequently after the second dose (P = .001). Fever (P = .03), fatigue (P = .02) and nausea/vomiting (P = .03) were significantly more frequent after the second dose of the vaccine (Figure 1). Analysis of the data detected statistically significant differences in duration of axillary swelling/tenderness (P = .07) and diarrhoea (P = .02) between the first and second. In both cases, these symptoms lasted longer after the second dose of the vaccine. There were no age-related differences in the rate of AEs between older (≥65 years) and younger participants (18–64 years). Lastly, we noted a lower rate of AEs in hemodialysis patients after the first dose (57.9% versus 84.2%) and second doses (61.9% versus 88.6%) compared to the general population.FIGURE 1: Number of patients who experienced AEs after the two doses. CONCLUSION RNA-1273 vaccine was associated with the development of transient AEs after the first (57.9%) and second doses (61.9%) in patients on haemodialysis. Systemic AEs were more common after the second dose than the first dose of vaccine. The duration of AEs lasted for a few days, without any apparent consequences. These data confirm the safety of the RNA-1273 vaccine in haemodialysis patients and support the promotion of COVID-19 vaccination in h sitant patients.

Covid-19 in Patients on Peritoneal Dialysis: A Case-Series

BACKGROUND AND AIMS A great amount of information has been divulged on the epidemiology and outcome of coronavirus disease 2019 (COVID-19) in patients with ESRD. The majority of the studies have been conducted in patients on maintenance hemodialysis (HD) and kidney transplant recipients. Unfortunately, few studies focused on the outcome of peritoneal dialysis (PD) patients. Information regarding this subset of the population has been extrapolated from aggregated data including a higher percentage of HD patients. As a result, the impact of COVID-19 is indefinite in patients receiving PD. We conducted a study to better understand how patients on PD have been affected by COVID-19. METHOD We conducted a single-center retrospective analysis of 141 PD patients followed at the University Hospital of Modena, Italy from 1 March 2020 to 31 December 2021. The diagnosis of COVID-19 was performed through nasopharyngeal swab RT–PCR testing. Duration of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) shedding measured the time elapsed from diagnosis of COVID-19 to one or two (if available) negative nasopharyngeal PCR tests. Median and interquartile range or mean and standard deviation were used for continuous variables and percentage for categorical variables. A P-value <0.05 was considered statistically significant. RESULTS During the pandemic, 18 out of 141 (12.7%) patients receiving PD dialysis contracted COVID-19. Median age was 60 (50.2–66.5) years with a predominance of males (72.2%) The percentage of patients on APD accounted for 33.3%. The infection was symptomatic in out of 18 (94.4%) patients. Fever (94.4%) and cough (55.6%) were the most common symptoms. Viral shedding, traced with nasopharyngeal swabs lasted 26 (14.5–3.5) days. Two patients were inactive on the waiting list for kidney transplantation for a mean of 43 ± 1.4 days. COVID-19 caused hospital admission of seven (38.9%) patients. During hospitalization two (11.1%) patients switched from PD to HD for ultrafiltration failure and inadequate solute clearance and two (11.1%) died for septic shock with multiorgan failure. In our cohort of patients, excess death due to COVID-19 was 22.2%. Half of the patients contracted the infection before the availability of SARS-CoV-2 vaccine. There were no statistically significant differences between vaccinated and unvaccinated patients in terms of symptoms, viral shedding and hospital admission or (Table 1). We underline that COVID-19 was fatal only in two unvaccinated patients.Table 1. Demographic and clinical characteristics of patients on PD with COVID-19VariablesAllpatientsUnvaccinated patientsVaccinated patientsP-value(n. 18)(n. 9)(n. 9)Age, years60 (50.2–66.5)54 (52–65)62 (39–73)0.96Male, n. (%)13 (72.2)8 (88.8)5 (55.5)0.29Dialysis vintage, years0.9 (0.7–2.4)1.2 (0.5–2.9)0.94 (0.7–2)0.85CAPD, n. (%)6 (33.3)2 (33.3)4 (44.4)0.6Immunosuppressive therapy6 (33.3)1 (16.7)5 (55.5)0.13Etiology of ESRD0.59 Hypertensive nephropathy6 (33.3)4 (44.4)2 (22.2) Diabetic nephropathy3 (16.7)2 (22.2)1 (11.1) IgA nephropathy2 (11.1)1 (11.1)1 (11.1) Lupus nephritis2 (11.1)0 (0)2 (22.2) Others5 (27.8)2 (22.2)3 (33.3)Comorbidities  Diabetes6 (33.3)3 (33.3)3 (33.3)1  CVD7 (38.9)4 (44.4)3 (33.3)1 Obesity5 (27.8)2 (22.2)3 (33.3)1  Cancer3 (16.7)2 (22.2)1 (11.1)1Symptoms  Cough10 (55.6)7 (77.7)3 (33.3)0.15  Fever17(94.4)9 (100)8 (88.8)1  Dyspnea6 (33.3)3 (33.3)3 (33.3)1Asymptomatic, n. (%)1 (5.6)0 (0)1 (11.1)1Viral shedding, day26 (14.5–33.5)26 (15–35)27.5 (11.5–33)0.51Switch to HD2 (11.1)1 (11.1)1 (11.1)1Hospitalization, n. (%)7 (38.9)3 (33.3)4 (44.4)1Death, n. (%)2 (11.1)2 (22.2)0 (0)0.47 CONCLUSION This study reports the monocentric experience of a large PD center during the COVID-19 pandemic. COVID-19 was symptomatic in the majority of patients and led to hospitalization of about 40% of the patients. The rate of symptoms, viral shedding and hospital admission was similar between vaccinated and unvaccinated patients. Two unvaccin ted patients died for the severe consequence of COVID-19.

Which criteria should we use to end isolation in hemodialysis patients with COVID-19?

Safe and timely discontinuation of quarantine of in-center hemodialysis (HD) patients with a previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is a challenging issue for the nephrological community because current guidelines for ending isolation do not mention dialysis patients. To prevent potentially fatal outbreaks of coronavirus disease 2019 (COVID-19), a cautionary approach has been adopted by most dialysis units. The criteria for ending the isolation in the HD population generally coincide with those recommended for immunocompromised people. Thus, a test-based strategy relying on two consecutive negative reverse transcriptase-polymerase chain reaction (RT-PCR) nasopharyngeal swabs has been adopted to terminate quarantine. This strategy has the disadvantage of prolonging isolation as RT-PCR positivity does not equate to SARS-CoV-2 infectivity. Consequentially, prolonged positivity of SARS-CoV-2 results in excessive workload for the HD staff who must face an increasing number of COVID-19 patients requiring isolation. This condition leads also to serious implications for the patients and their households including work productivity loss, postponement of health-care appointments and an increased risk of COVID-19 reinfection. To counteract this problem, other diagnostic tests should be used to provide the best care to HD patients. Recent results seem to encourage the use of RT-PCR cycle threshold (Ct) values and rapid antigen tests given their better correlation with cell culture for SARS-CoV-2 than RT-PCR testing. Here, we provide an overview of the current scientific evidence on the tests used to verify the infectiousness of the virus in order to stimulate the nephrological community to adopt a streamlined and pragmatic procedure to end isolation in COVID-19 patients on HD.

Reactogenicity of COVID-19 vaccine in hemodialysis patients: a single-center retrospective study.

Introduction: Some hemodialysis patients are reluctant to undergo COVID-19 vaccination for the fear of developing adverse events (AEs). The aim of this study was to verify the safety of the mRNA-1273 vaccine in hemodialysis patients. Methods: We conducted a retrospective analysis of in-center hemodialysis patients who underwent mRNA-1273 vaccine from March 1st to April 30th, 2021. All AEs occurring after the first and the second doses were collected and classified as local or systemic. Results: Overall, 126 patients on chronic maintenance dialysis without a prior COVID-19 diagnosis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54,7-76) years and 53.6% of patients were aged ≥65 years. During the observational period of 68 (IQR, 66-70) days, AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were: injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%), nausea/vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%). The rates of local AEs were similar after the first and second doses (P=0.8), whereas systemic AEs occurred more frequently after the second dose (P=0.001). Fever (P=0.03), fatigue (P=0.02) and nausea/vomiting (P=0.03) were significantly more frequent after the second dose of the vaccine. There were no age-related differences in the rate of AEs. Overall, vaccine-related AEs in hemodialysis patients seem to be lower than in the general population. Conclusion: The RNA-1273 vaccine was associated with the development of transient AEs after the first and second doses in patients on chronic maintenance hemodialysis. They were mostly local, whereas systemic AEs were more prevalent after the second dose. Overall, all AEs lasted for a few days, without any apparent sequelae.

Awaiting a cure for COVID-19: therapeutic approach in patients with different severity levels of COVID-19.

COVID-19 is an unpredictable infectious disease caused by SARS-CoV-2. The development of effective anti-COVID-19 vaccines has enormously minimized the risk of severe illness in most immunocompetent patients. However, unvaccinated patients and non-responders to the COVID-19 vaccine are at risk of shortand long-term consequences. In these patients, the outcome of COVID-19 relies on an interplay of multiple factors including age, immunocompetence, comorbidities, inflammatory response triggered by the virus as well as the virulence of SARS-CoV-2 variants. Generally, COVID-19 is asymptomatic or mildly symptomatic in young people, but it may manifest with respiratory insufficiency requiring mechanical ventilation in certain susceptible groups of patients. Furthermore, severe SARS-CoV-2 infection induces multiorgan failure syndrome by affecting liver, kidney heart and nervous system. Since December 2019, multiple drugs have been tested to treat COVID-19, but only a few have been proven effective to mitigate the course of the disease that continues to cause death and comorbidity worldwide. Current treatment of COVID-19 patients is essentially based on the administration of supportive oxygen therapy and the use of specific drugs such as steroids, anticoagulants, antivirals, anti-SARS-CoV-2 antibodies and immunomodulators. However, the rapid spread of new variants and the release of new data coming from the numerous ongoing clinical trials have created the conditions for maintaining a continuous updating of the therapeutic management of COVID-19 patients. Furthermore, we believe that a well-established therapeutic strategy along with the continuum of medical care for all patients with COVID-19 is pivotal to improving disease outcomes and restoring healthcare care fragmentation caused by the pandemic. This narrative review, focusing on the therapeutic management of COVID-19 patients, aimed to provide an overview of current therapies for (i) asymptomatic or mildly/moderate symptomatic patients, (ii) hospitalized patients requiring low-flow oxygen, (iii) high-flow oxygen and (iv) mechanical ventilation.

One-year persistence of neutralizing anti-SARS-CoV-2 antibodies in dialysis patients recovered from COVID-19.

The immunological mechanisms that modulate immune response to SARS-CoV-2 infection remain elusive. Little is known on the magnitude and the durability of antibody response against COVID-19. There is consensus that patients with immune dysfunction, such as dialysis patients, may be unable to mount a robust and durable humoral immunity after infections. Recent studies showed that dialysis patients seroconverted after COVID-19, but data on the durability of the immune response are missing. We reported the data of a durable anti-spike protein seroconversion after natural SARS-CoV-2 infection in three patients on hemodialysis with a mean age of 67.2 ± 13.8 years. A mean antibody titer of 212.6 ± 174.9 UA/ml (Liaison®, DiaSorin) was found after one year (range, 366-374 days) from the diagnosis of COVID-19. In conclusion, this case series provided evidence that patients receiving hemodialysis who recovered from severe COVID-19 were able to mount a long-lasting immune response against SARS-CoV-2. Although the protective capacity of this long-term immunity remains to be determined, these patients did not report signs of reinfection after recovery from COVID-19.

Similar Rates of AKI during the First Two Waves of COVID-19 in Northern Italy: a single-center study (preprint)

Introduction Two waves of COVID-19 cases have overwhelmed most European countries during 2020. It is unclear if the incidence of acute kidney injury (AKI) has changed during the COVID-19 outbreaks. This study aims to evaluate the differences in incidence, risk factors and outcome of AKI in patients with SARS-CoV-2 infection during the first and second wave of COVID-19. Method We reviewed the health medical records of 792 consecutive patients with COVID-19 hospitalized at the University Hospital of Modena, Italy, from February 25 to December 14, 2020. Results AKI was diagnosed in 122 (15.4%) patients. Incidence of AKI remained steady rate during wave-1 (15.9%) and wave-2 (14.7%) (P=0.89). AKI patients were older (P=<0.001) and had a more severe respiratory impairment (PO2/FO2) (P=≤0.001) than their non-AKI counterparts. AKI led to a longer hospital stay (P=0.001), complicated with a higher rate of ICU admission. COVID-19-related AKI was associate with 59.7% of deaths during wave-1 and 70.6% during wave-2. At the end of the period of observation, 24% (wave-1) and 46.7% (wave-2) of survivors were discharged with a not fully recovered kidney function. Risk factors for AKI in patients with COVID-19 were diuretics (HR=5.3; 95%CI, 1.2-23.3; P=0.025) and cardiovascular disease (HR, 2.23; 95%CI, 1.05-5.1; P=0.036). Conclusion The incidence of AKI (about 15%) remained unchanged during 2020, regardless of the trend of COVID-19. AKI occurred in patients with severe COVID-19 symptoms and was associated with a higher incidence of deaths than non-AKI patients. The risk factors of COVID-19-related AKI were diuretic therapy and cardiovascular disease.