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BackgroundPatients with immune-mediated rheumatic diseases (IRD) have poorer outcomes of SARS-CoV-2 infection compared to the general population.ObjectivesTo assess and compare clinical course, severity and complications of SARS-CoV-2 infection in patients with rheumatic immune-mediated inflammatory diseases (IMIDs) from Mexico and Argentina.MethodsData from both national registries, CMR-COVID (Mexico) and SAR-COVID (Argentina), were combined. Briefly, adult IRD patients with SARS-CoV-2 infection were recruited between 08.2020 and 09.2022 in SAR-COVID and between 04.2020 and 06.2022 in CMR-COVID. Sociodemographic data, comorbidities, and DMARDs were recorded, as well as clinical characteristics, complications, and treatment for SARS-CoV-2 infection. Descriptive analysis. Chi square, Fisher, Student T, Mann Whitney U tests and multiple logistic regression analyses were performed.ResultsA total of 3709 patients were included, 1167 (31.5%) from the CMR-COVID registry and 2542 (68.5%) from the SAR-COVID registry. The majority (82.3%) were women, with a mean age of 50.4 years (SD 14.4). The most frequent IRD were rheumatoid arthritis (47.5%) and systemic lupus erythematosus (18.9%). Mexican patients were significantly older, had a higher female predominance and had higher prevalence of rheumatoid arthritis, antiphospholipid syndrome, and axial spondyloarthritis, while the Argentine patients had more frequently psoriatic arthritis and ANCA-associated vasculitis. In both cohorts, approximately 80% were in remission or low disease activity at the time of infection. Mexicans took glucocorticoids (43% vs 37%, p<0.001) and rituximab (6% vs 3%, p<0.001) more frequently. They also reported more comorbidities (48% vs 43%, p=0.012).More than 90% of patients presented symptoms related to SARS-CoV-2 infection. The frequency of hospitalization was comparable between the groups (23.4%), however, the Mexicans had more severe disease (Figure 1) and a higher mortality rate (9.4% vs 4.0%, p<0.0001). After adjusting for risk factors, Mexicans were more likely to die due to COVID-19 (OR 2.2, 95%CI 1.5-3.1).ConclusionIn this cohort of patients with IRD from Mexico and Argentina with SARS-CoV-2 infection, the majority presented symptoms, a quarter were hospitalized and 6% died due to COVID-19. Mexicans presented more severe disease, and after considering risk factors they were two times more likely to die.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsCarolina Ayelen Isnardi Grant/research support from: SAR-COVID is a multi- sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or infuenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database, Deshire Alpizar-Rodriguez: None declared, Marco Ulises Martínez-Martínez: None declared, Rosana Quintana: None declared, Ingrid Eleonora Petkovic: None declared, Sofia Ornella: None declared, Vanessa Viviana Castro Coello: None declared, Edson Velozo: None declared, David Zelaya: None declared, María Severina: None declared, Adriana Karina Cogo: None declared, Romina Nieto: None declared, Dora Aida Pereira: None declared, Iris Jazmin Colunga-Pedraza: None declared, Fedra Irazoque-Palazuelos: None declared, GRETA CRISTINA REYES CORDERO: None declared, Tatiana Sofía Rodriguez-Reyne: None declared, JOSE ANTONIO VELOZ ARANDA: None declared, Cassandra Michele Skinner Taylor: None declared, INGRID MARIBEL JUAREZ MORA: None declared, Beatriz Elena Zazueta Montiel: None declared, Atzintli Martínez: None declared, Cesar Francisco Pacheco Tena: None declared, Guillermo Pons-Estel: None declared.
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Background: Persistent symptoms after acute COVID have been described previously. Main symptoms reported are fatigue, arthralgias, myalgias and mental sickness. Defnition and methods vary widely.1 Objectives: To asses prevalence and related factors to long COVID in a retrospective cohort of patients with rheumatic diseases from Argentina. Methods: A total of 1915 patients were registered from August 18th, 2020 to July 29th, 2021. Patients > 18 years old, with rheumatic disease and confrmed infection by SARS-CoV-2 (antigen or RT-PCR) were included. Those dead, with unknown outcome, wrong date or missing data were excluded. Demographic data, comorbidities, rheumatic disease, and characteristics of SARS-CoV-2 infection were recorded. Long COVID was defned according to NICE guidelines (persistent symptoms for more than 4 weeks, without alternative diagnosis). Long COVID symptoms were defned by rheumatologist. Severity of infection was clas-sifed according to WHO ordinal scale. We used descriptive statistics, univariate model (Student's test, chi square test, ANOVA) and multivariate logistic regression analysis. Results: 230 (12%) had long COVID. Median age was 51 (IQR 40-61]) years, 82% were females, 51% were not caucasian. Median of education was 13.3 years (IQR 12-16), 79 % had private health insurance and 55 % were employed. Nearly half (n=762, 46%) had comorbidities, the most prevalent was hypertension (n=396, 24%). The most frequent rheumatic diseases were rheumatoid arthritis (n=719, 42%) and systemic lupus ery-thematosus (n=280, 16 %). Most were in low activity/remission (79%), used Conventional DMARD (n=773 patients, 45%) and steroids (n=588, 34%) at low dose (n=415, 71%). Main laboratory findings were abnormal D-di-mer (n=94, 28%) and leukopenia (n=93, 26%). Most patients had a WHO ordinal scale < 5 (n=1472, 86%). Median of hospitalization at intensive care unit (ICU) was 8 days [IQR 5, 13]. Treatment for SARS-CoV-2 infection (steroids, anticoagulation, azithromycin, convalescent plasma) was used in 461 (27%) patients. Most of long COVID (n= 152, 69%) reported 1 symptom, the most frequent was fatigue (n= 55, 22%). Figure 1. Univariate analysis is presented in Table 1. In multivariate logistic regression analysis non-caucasian ethnicity OR 1.44 (1.07-1.95), years of education OR 1.05 (1-1.09), treatment with cyclophosphamide OR 11.35 (1.56-112.97), symptoms of COVID-19 OR 13.26 (2.75-242.08), severity scale WHO ≥ 5 OR 2.46 (1.68-3.57), and ICU hospitalization days OR 1.09 (1.05-1.14) were factors associated to long COVID. Conclusion: Prevalence of long COVID was 12%. Non-caucasian ethnicity, higher education, treatment with cyclophosphamide, symptoms of COVID-19, severe disease and ICU hospitalization days were related to long COVID.
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Background: Patients with rheumatic diseases (RD) have been excluded from SARS-CoV-2 vaccine trials. Though data appear to show safety and efficacy, mostly evidence remains in mRNA vaccines. However in our country, adenovirus and inactivated vaccines, as well as heterologous schemes are frequently used. Objectives: To describe clinical characteristics and outcomes of SARS-CoV-2 infection after vaccination in patients with RD from de the SAR-CoVAC registry and to compare them with patients who got infected before vaccination. Additionally, factors associated with COVID-19 unfavorable outcome were assessed. Methods: Adult patients with RD who have been vaccinated for SARS-CoV-2 were consecutively included between June 1st and December 21st, 2021. Con-frmed SARS-CoV-2 infection (RT-PCR o serology) was reported by the treated physician. Infection after an incomplete scheme was defned when the event was diagnosed at least 14 days after frst dose;and after a complete scheme when it occurred > 14 days after second dose. Homologous scheme is defned by two same doses of vaccine and heterologous by two different doses. Patients with previous SARS-CoV-2 infection were excluded. To compare SARS-CoV-2 infection characteristics in not vaccinated patients, subjects from the SAR-COVID registry, which includes patients with RD and SARS-CoV-2 infection, were matched 2:1 by gender, age and RD. WHO-Ordinal Scale ≥5 was used to defne unfavorable infection outcome. Descriptive statics, Chi2 test, Fischer test, T test and ANOVA were used. Results: A total of 1350 patients from the SAR COVAC registry were included, 67 (5%) presented SARS-CoV-2 infection after vaccination. The later were mostly (72%) females with a mean age of 57 (SD 15) years old. The most frequent RD were rheumatoid arthritis (41%), psoriatic arthritis (12%) and systemic lupus erythematosus (10%). At vaccination, most of them (75%) had low disease activity or remission, 19% were taking steroids, 39% methotrex-ate, 27% bDMARDs and 6% JAK inhibitors. A total of 11 (16%) patients had SARS-CoV-2 infection <14 days after the frst vaccine dose, 39 (58%) after an incomplete scheme and 17 (25 %) following a complete one. In the incomplete scheme group, 59% received Gam-COVID-Vac, 31% ChAdOx1 nCov-19 and 10% BBIBP-CorV;and in patients with complete scheme 47%, 24% and 29%, respectively. No event was reported after a complete heterologous scheme. No signifcant differences regarding sociodemoghraphic characteristics, RD, disease treatment, type of vaccine and regimen was found between in those with infection and those without it. After vaccination only 8 (12%) of the patients who got infected had an unfavorable course, 88% of them following an incomplete scheme (5 received Gam-COVID-Vac, 1 ChAdOx1 nCov-19 and 1 BBIBP-CorV) and one subject after a complete homologous Gam-COVID-Vac scheme. Having an unfavorable outcome of SARS-CoV-2 infection was associated to: male gender [63% vs 24%, p=0.036], older age [mean 70 years (SD 7) vs 55 years (SD 15), p=0.005], being Caucasian [100% vs 54%, p=0.018], higher education [mean 17 years (SD 4) vs 12 years (SD 4), p=0.010], the presence of comorbid-ities [100% vs 39%, p=0.001, having pulmonary disease [37% vs 5%, p=0.019], dyslipidemia [63% vs 17%, p=0.011] and arterial hypertension [63% vs 24%, p=0.036], RD, treatments, disease activity and types of vaccines received were comparable between groups. When comparing patients with and without vaccination prior SARS-CoV-2 infection, those who received at least one dose of vaccine had less frequently severe COVID-19 (12% vs 24%, p=0.067) and presented lower mortality due to COVID-19 (3% vs 6%, p=0.498). However these differences did not reach statistical signifcance. Conclusion: In the SAR-CoVAC registry 5% of the patients had SARS-CoV-2 infection after vaccination, most of them mild and 25% after a complete scheme. Any vaccine was associated with severe COVID-19. When comparing with non-vaccinated patients, those with at least one dose, had less frequently severe disease and died due COVID-19.
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Background: Currently there is little information on the efficacy and safety of SARS-CoV-2 vaccination in patients with immune-mediated diseases and/or under immunosuppressive treatment in our country, where different types of vaccines and mix regimens are used. For this reason, the Argentine Society of Rheumatology (SAR) with the Argentine Society of Psoriasis (SOARPSO) set out to develop a national register of patients with rheumatic and immune-mediated infammatory diseases (IMIDs) who have received a SARS-CoV-2 vaccine in order to assess their efficacy and safety in this population. Objectives: To assess SARS-CoV-2 vaccine efficacy and safety in patients with rheumatic and IMIDs. Methods: SAR-CoVAC is a national, multicenter and observational registry. Adult patients with a diagnosis of rheumatic or IMIDs who have been vaccinated for SARS-CoV-2 were consecutively included between June 1st and September 17th, 2021. Sociodemographic data, comorbidities, underlying rheumatic or IMIDs, treatments received and their modifcation prior to vaccination and history of SARS-CoV-2 infection were recorded. In addition, the date and place of vaccination, type of vaccine applied, scheme and indication will be registered. Finally, adverse events (AE), as well as SARS-CoV-2 infection after the application of the vaccine were documented Results: A total of 1234 patients were included, 79% were female, with a mean age of 57.8 (SD 14.1) years. The most frequent diseases were rheumatoid arthritis (41.2%), osteoarthritis (14.5%), psoriasis (12.7%) and spondy-loarthritis (12.3%). Most of them were in remission (28.5%) and low disease activity (41.4%). At the time of vaccination, 21% were receiving glucocorti-coid treatment, 35.7% methotrexate, 29.7% biological (b) Disease Modifying Anti-Rheumatic Drugs (DMARDs) and 5.4% JAK inhibitors. Before vaccine application 16.9% had had a SARS-CoV-2 infection. Regarding the frst dose of the vaccine, the most of the patients (51.1%) received Gam-COV-ID-Vac, followed by ChAdOx1 nCoV-19 (32.8%) and BBIBP-CorV (14.5%). In a lesser proportion, BNT162b2 (0.6%), Ad26.COV2.S (0.2%) and Coro-naVac (0.2%) vaccines were used. Almost half of them (48.8%) completed the scheme, 12.5% were mix regimenes, the most frequent being Gam-COVID-Vac/mRNA-1273. The median time between doses was 51days (IQR 53). More than a quarter (25.9%) of the patients reported at least one AE after the frst dose and 15.9% after the second. The fu-like syndrome and local hypersensitivity were the most frequent manifestations. There was one case of mild anaphylaxis. No patient was hospitalized. Altogether, the incidence of AE was 246.5 events/1000 doses. BBIBP-CorV presented signifcantly lower incidence of AE in comparison with the other types of vaccines. (118.5 events/1000 doses, p<0.002 in all cases) Regarding efficacy, 63 events of SARS-CoV-2 infection were reported after vaccination, 19% occurred before 14 days post-vaccination, 57.1% after the frst dose (>14 days) and 23.8% after the second. In most cases (85.9%) the infection was asymptomatic or had an outpatient course and 2 died due to COVID-19. Conclusion: In this national cohort of patients with rheumatic and IMIDs vaccinated for SARS-CoV-2, the most widely used vaccines were Gam-COVID-Vac and ChAdOx1 nCoV-19, approximately half completed the schedule and in most cases homologously. A quarter of the patients presented some AE, while 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild.
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Background: Comorbidities, particularly cardio-metabolic disorders, are highly prevalent in patients with psoriatic arthritis (PsA) and they were associated with an increased risk of atherosclerotic cardiovascular disease, which have been associated with higher morbidity and mortality. Whether PsA enhances the risk of SARS-CoV-2 infection or affects the disease outcome remains to be ascertained. Objectives: To describe the sociodemographic, clinical and treatment characteristics of patients with PsA with confrmed SARS-CoV-2 infection from the SAR-COVID registry and to identify the variables associated with poor COVID-19 outcomes, comparing them with those with rheumatoid arthritis (RA). Methods: Cross-sectional observational study including patients ≥18 years old, with diagnosis of PsA (CASPAR criteria) and RA (ACR/EULAR 2010 criteria), who had confrmed SARS-CoV-2 infection (RT-PCR or serology) from the SAR-COVID registry. Recruitment period was between August 13, 2020 and July 31, 2021. Sociodemographic variables, comorbidities, and treatments were analyzed. To assess the severity of the infection, the ordinal scale of the National Institute of Allergy and Infectious Diseases (NIAID)1 was used, and it was considered that a patient met the primary outcome, if they presented criteria of categories 5 or higher on the severity scale. For this analysis, Chi2 test, Fisher's test, Student's test or Wilcoxon test, and binomial logistic regression using NIAID>=5 as dependent variable were performed. Results: A total of 129 PsA patients and 808 with RA were included. Clinical characteristics are shown in Table 1. Regarding PsA treatment, 12.4% of PsA were receiving IL-17 inhibitors, 5.4% IL12-23 inhibitors, one patient apremilast and one abatacept. The frequency of NIAID≥5 was comparable between groups (PsA 19.5% vs RA 20.1%;p=0.976). (Figure 1). PsA patients with NIAID≥5 in comparison with NIAID<5 were older (58.6±11.4 vs 50±12.5;p=0.002), had more frequently hypertension (52.2% vs 23%;p=0.011) and dyslipidemia (39.1% vs 15%;p=0.017). In the multivariate analysis, age (OR 1.06;95% CI 1.02-1.11) was associated with a worse outcome of the COVID-19 (NIAID≥5) in patients with PsA, while those who received methotrexate (OR 0.34;95% CI 0.11-0.92) and biological DMARDs (OR 0.28;95% CI 0.09-0.78) had a better outcome. Conclusion: Although PsA patients have a higher frequency of cardiovascular and metabolic comorbidities than those with RA, the COVID-19 severity was similar. Most of the patients had mild SARS-CoV-2 infection and a low death rate.
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Objectives: To describe the incidence and severity of COVID-19 disease in Spondyloarthritis patients in Argentina. Methods: Patients with axial spondyloarthritis (AxSpA) radiological (AS) and non-radiological (AxSpA-nr) and peripheral spondyloarthritis (according to ASAS criteria, SpAp) and Psoriatic arthritis (PsA) (according to CASPAR criteria) were included. The patients were followed up by phone or in person on a monthly basis. Data were collected from 1/4/2020 to 20 / 9/2020. Descriptive statistics were performed with mean and standard deviation (SD) and median and 25-75 percentile according to distribution, and the cumulative incidence (CI) of the disease was calculated. Results: 320 patients were included, of which 55%were male, with a mean age of 50 (SD 13), 21.6% had a diagnosis of AS, 6.9% AxSpA-nr, 6.9% SpAp and 64.7% PsA. The duration of the disease was 11 (5-16), BASDAI 3.65 (3), BASFI 3 (1.5-9), PASI 0.3 (0-7), BSA 0.2 (0-6). Fourteen patients with a diagnosis of COVID-19 (4.4%) were reported, of which 10 diagnoses were by positive PCR and 4 by symptoms associated with positive close contact. Thirteen (93%) cases were patients from the Province of Buenos and Ciudad Autónoma de Buenos Aires (CABA) and 1 patient from Santiago del Estero. The total CI of the country was 0.04, the CI of the Province of Buenos Aires + CABA 0.04, and the CI of the rest of the provinces 0.01. Of the 14 patients with COVID-19: 50% were men;4 have a diagnosis of AS, 1 of SpAax-nr, 9 (64.3%) PsA. All of them in urban areas, 79% have social work, 2 (14%) have hypertension, 1 (7%) diabetes mellitus, 4 (28.6%), hypothyroidism, 1 (7%) Chronic Obstructive Pulmonary Disease, 2 (14%) Depression o Anxiety. Regarding the treatments: 4 (28.6%) were in treatment with anti TNF (3 with Adalimumab, 1 with certolizumab pegol), 4 (28.6%) with Anti IL17 (3 with Secukinumab and 1 with Ixekizumab), 8 (57%) methotrexate and 2 (14%) Leflunomide, 1 (7%) were under treatment with Enalapril, 1 (7%) with Losartan. 10 (71.4%) stayed at home, 3 (21.4%) hospitalized in the common room and 1 (7) in the intensive care unit. No patients died due to COVID-19. Conclusion: An incidence of 4.4% of COVID-19 was found in this SpA population, most of the cases occurred in the Province of Buenos Aires and CABA, most of them suffered mild symptoms and no deaths were reported.
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Background: Access to high-cost treatments is especially limited in low-resource countries. This issue is becoming stronger today given the health and economic crisis caused by the SARS-CoV2 pandemic. There are no reports in our country on limitations to access and adherence to treatment in patients with Spondyloarthritis (SpA) during social preventive and mandatory isolation. Objectives: Evaluate access and adherence to treatment in patients with Spondyloarthritis during social preventive and mandatory isolation. Methods: Patients with axial spondyloarthritis (axSpA) radiological (r-axSpA), non-radiological (nr-axSpA) and peripheral spondyloarthritis (pSpA), according to ASAS criteria and psoriatic arthritis (PsA) according to CASPAR criteria, were included. Sociodemographic data, comorbidities, disease activity and treatments were collected at baseline. Data on treatment discontinuation, medical attention for suspected COVID-19 disease, RT-qPCR for SARS-CoV-2 detection and outcome of COVID-19 disease were collected from April to September 2020. Numerical variables were summarized as means and standard deviations (SD) or as medians and interquartiles 25-75 (IQ 25-75). Results: 320 patients were included, 55% were male, with a mean age of 50 years (SD 13), 21.6% had diagnosis of r-axSpA, 6.9% nr-axSpA, 6.9% pSpA, and 64.7% PsA. Disease duration was 11 (IQ 5-16) years and activity parameters were as follow: BASDAI 3.65 (SD 3), BASFI 3 (1.5-9), PASI 0.3 (0-7), BSA 0.2 (0-6). 14 (4.4%) patients with COVID-19 disease were reported, 10 were confirmed by positive RT-qPCR and 4 by symptoms and history of close contact with SARS patients. 4 (28.6%) received anti TNF (3 adalimumab, 1 certolizumab), 4 (28.6%) anti IL17 (3 secukinumab and 1 ixekizumab), 8 (57%) methotrexate (MTX) and 2 (14%) leflunomide (LF). Among the 320 patients included, 59 (18.4%) discontinued at least one treatment during follow-up. The discontinued medications were: adalimumab (16), MTX (15), secukinumab (9), etanercept (6), certolizumab(4), ustekinumab (3), NSAIDs (2), apremilast (1), golimumab (1), ixekuzumab (1), LF (1), MTX plus LF (1). The main reason for treatment discontinuation was drug shortage: 36 (62%), followed by patient's decision: 12 (21%) and medical indication: 11 (17%). Of the 36 patients who discontinued due to shortage, 11 received adalimumab, 8 secukinumab, 5 MTX, 3 etanercept, 3 certolizumab, 3 ustekinumab, 2 NSAIDs and 1 golimumab. Conclusion: In our Argentinian cohort of patients with SpA, drug shortage was the main reason for treatment discontinuation. The SARS-CoV2 pandemic exposed limitations to access to treatment for patients with SpA.
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Background: There are limited data worldwide on the behavior of SARSCOV2 in patients with Spondyloarthritis (SpA). Objectives: To describe the incidence and severity of COVID-19 disease in patients with SpA in Argentina. Methods: Patients with axial spondyloarthritis (AxSpA) radiological (EA) and non-radiological (AxSpA-nr) and peripheral spondyloarthritis (according to ASAS criteria) and psoriatic arthritis (PsA) (according to CASPAR criteria) were included. Sociodemographic data, comorbidities, disease activity and treatments were collected at baseline. The patients were followed up by phone or in person monthly. Data were collected from 1/4/2020 to 9/20/2020. Descriptive statistics were performed with mean and standard deviation (SD) and median and quartile 25-75 according to distribution, and the cumulative incidence (AI) of the disease was calculated. Results: 320 patients were included, of which 55% were male, with a mean age of 50 SD 13, 21.6% had a diagnosis of AS, 6.9% SpAax-nr, 6.9% SpAp, and 64.7% PsA, BASDAI 3.65 (3), BASFI 3 (1.5-9), PASI 0.3 (0-7), BSA 0.2 (0-6). Fourteen patients with a diagnosis of COVID-19 (4.4%) were reported, of which 10 diagnoses were by positive PCR and 4 by positive symptoms and close contact. 93% (13) of the cases were patients from the Province of Buenos and CABA and 1 patient from Santiago del Estero. The total IA for the country was 0.04. Of the 14 patients with COVID-19, 7 (50%) were men, 4 had a diagnosis of AS, 1 of SpAax-nr, 9 (64.3%) PsA. 100% live in urban areas, 2 (14%) have hypertension, 1 (7%) DBT, 1 (7%) COPD, 2 (14%) depression or anxiety, 11(97%) had received influenza vaccine 2020, 13 (93%), Antineumoccic 23, 14 (100%) Antineumoccic 13. Regarding the treatments: 4 (28.6%) were in treatment with anti TNF (3 with Adalimumab, 1 with certolizumab pegol), 4 (28.6%) with Anti IL17 (3 with Secukinumab, 1 with Ixekizumab), 8 (57%) with methotrexate and 2 (14%) with Leflunomide. Place of follow-up of the disease: 10 (71.4%) at home, 3 (21.4%) in the common room and 1 (7) in the intensive care unit. Treatments received for COVID-19: 1 (7%) antiretroviral, 1 (7%) antibiotic and 1 (7%) steroids. None of the patients died from COVID-19. Conclusion: An incidence of 4.4% of COVID-19 was found in this population with SpA and most of the patiend had mild symptoms and no deaths were reported. .