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182 Figure 1Cardiovascular events in COVID-19 Survivors by LGE Status[Figure omitted. See PDF] 182 Figure 2All-cause mortality in COVID-19 Survivors by LGE Status[Figure omitted. See PDF]Conflict of InterestNone
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BackgroundConsideration is needed when using Janus kinase (JAK) inhibitors to treat RA in pts aged ≥65 years or those with cardiovascular (CV) risk factors. The JAK1 preferential inhibitor FIL was generally well tolerated in clinical trials[1];safety has not been determined in a real-world setting.ObjectivesTo report baseline characteristics and up to 6-month safety data from the first 480 pts treated with FIL in the FILOSOPHY study (NCT04871919), and in two mutually exclusive subgroups based on age and CV risk.MethodsFILOSOPHY is an ongoing, phase 4, non-interventional, European study of pts with RA who have been prescribed FIL for the first time and in accordance with the product label in daily practice. Baseline characteristics and the incidence of select adverse events (AEs) are assessed in pts aged ≥65 years and/or with ≥1 CV risk factor (Table 1), and in those aged <65 years with no CV risk factors.ResultsAs of the end of June 2022, 480 pts had been treated: 441 received FIL 200 mg and 39 received FIL 100 mg. Of the 480 pts, 148 (30.8%) were aged ≥65 years;332 (69.2%) were aged <65 years. In total, 86 (17.9%) were former smokers, 81 (16.9%) were current smokers and 203 (42.3%) were non-smokers (data were missing for 110 pts [22.9%]). In addition to smoking, the most frequent CV risk factors included a history of hypertension (32.3%), a history of dyslipidemia (10.2%) and a family history of myocardial infarction (8.5%;Table 1).23 pts (4.8%) discontinued treatment due to AEs. Of the 354 pts aged ≥65 years or with ≥1 CV risk factor, infections affected 64 pts (18.1%), 34 (9.6%) had COVID-19, 2 (0.6%) had herpes zoster, and cardiac disorders (angina pectoris, atrial fibrillation, palpitations and tachycardia) affected 5 pts (1.4%);no cases of malignancies were observed. In the subgroup aged <65 years and with no CV risk factors (n=126), infections occurred in 18 pts (14.3%) (9 [7.1%] had COVID-19;3 [2.4%] had herpes zoster) and malignancies (myeloproliferative neoplasm) affected 1 pt (0.8%);no pts had cardiac disorders. There were no cases of deep vein thrombosis or pulmonary embolism in either subgroup.ConclusionIn this interim analysis of FILOSOPHY, no unexpected safety signals emerged at up to 6 months. Although infections and cardiac disorders affected a numerically greater proportion of pts aged ≥65 years or with ≥1 CV risk vs those aged <65 years with no CV risk, longer follow-up on a broader cohort is necessary to further characterize the safety of FIL in different groups of pts with RA.Reference[1]Winthrop K, et al. Ann Rheum Dis 2022;81:184–92Table 1.Baseline characteristics and CV risk factorsBaseline demographics/CV risk factorsAll FIL-treated pts (N=480)≥65 years or with ≥1 CV risk factor (n=354)<65 years and no CV risk factor (n=126)*Female sex, n (%)351 (73.1)252 (71.2)99 (78.6)Age, years, mean (SD)57.6 (11.5)60.4 (10.8)49.6 (9.6)Rheumatoid factor positive, n (%)†228 (47.5)167 (47.2)61 (48.4)Anti-citrullinated protein antibody positive, n (%)‡243 (50.6)176 (49.7)67 (53. 2)Body mass index, kg/m2, mean (SD)27.6 (5.7) n=43728.0 (5.4) n=33126.3 (6.4) n=106RA disease duration, years, mean (SD)10.4 (9.4) n=47810.5 (9.5) n=35310.0 (8.8) n=125Tender joint count 28, mean (SD)8.6 (6.9) n=4578.7 (7.1) n=3408.3 (6.3) n=117Swollen joint count 28, mean (SD)5.6 (5.2) n=4525.7 (5.4) n=3365.4 (4.4) n=116Former smoker, n (%)§86 (17.9)86 (24.3)0Current smoker, n (%)§81 (16.9)81 (22.9)0Non-smoker, n (%)§203 (42.3)130 (36.7)73 (57.9)Family history of myocardial infarction, n (%)41 (8.5)41 (11.6)0Medical history of: n (%) CV disease33 (6.9)33 (9.3)0 Diabetes35 (7.3)35 (9.9)0 Dyslipidemia49 (10.2)49 (13.8)0 Hypertension155 (32.3)155 (43.8)0 Ischemic CNS vascular disorders11 (2.3)11 (3.1)0 Peripheral vascular disease17 (3.5)17 (4.8)0*Includes 53 pts with missing smoking status data who were aged <65 years with no other CV risk factors.†Missing/unknown in 154 pts;‡Missing in 153 pts;§Smoking status data missing in 110 pts (22.9%).AcknowledgementsWe thank the physicia s and patients who participated in this study. The study was funded by Galapagos NV, Mechelen, Belgium. Publication coordination was provided by Fabien Debailleul, PhD, of Galapagos NV. Medical writing support was provided by Debbie Sherwood, BSc, CMPP (Aspire Scientific, Bollington, UK), and funded by Galapagos NV.Disclosure of InterestsPatrick Verschueren Speakers bureau: AbbVie, Eli Lilly, Galapagos, Roularta, Consultant of: Celltrion, Eli Lilly, Galapagos, Gilead, Nordic Pharma, Sidekick Health, Grant/research support from: Galapagos, Pfizer, Jérôme Avouac Speakers bureau: AbbVie, AstraZeneca, BMS, Eli Lilly, Galapagos, MSD, Novartis, Pfizer, Sandoz, Sanofi, Consultant of: AbbVie, Fresenius Kabi, Galapagos, Sanofi, Grant/research support from: BMS, Fresenius Kabi, Novartis, Pfizer, Karen Bevers Grant/research support from: Galapagos, Susana Romero-Yuste Speakers bureau: AbbVie, Biogen, BMS, Lilly, Pfizer, Consultant of: Sanofi, Lilly, Grant/research support from: Lilly, MSD, Roberto Caporali Speakers bureau: AbbVie, Amgen, BMS, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Sandoz, UCB, Consultant of: AbbVie, Amgen, BMS, Celltrion, Eli Lilly, Fresenius Kabi, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, UCB, Thomas Debray Consultant of: Biogen, Galapagos, Gilead, Francesco De Leonardis Employee of: Galapagos, James Galloway Speakers bureau: AbbVie, Biogen, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Grant/research support from: AstraZeneca, Celgene, Gilead, Janssen, Medicago, Novavax, Pfizer, Monia Zignani Shareholder of: Galapagos, Employee of: Galapagos, Gerd Rüdiger Burmester Speakers bureau: AbbVie, Amgen, BMS, Chugai, Galapagos, Lilly, Pfizer, Sanofi, Consultant of: AbbVie, Amgen, BMS, Galapagos, Lilly, Pfizer, Sanofi.
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IntroductionThe use of aspirin has been hypothesized to improve severe clinical outcomes in COVID-19 infection. The present study aims to evaluate the effect of both antecedent and inpatient aspirin use, individually and concomitant with other medications, on severe disease outcomes in COVID-19 positive patients treated with steroids/antiviral therapy.MethodsConsecutive patients who attended Hong Kong's public hospitals or outpatient clinics between 1st January and 8th December 2020 for COVID-19 reverse transcription-polymerase chain reaction (RT-PCR) and received steroids/antiviral therapy were included. Propensity score matching (1:1) between aspirin users and non-users was performed. The primary endpoint was the composite outcome of the need for intubation and 30-day all-cause mortality.ResultsA total of 2664 RT-PCR positive and hospitalized COVID-19 patients receiving steroids/antiviral therapy were included (male= 50.7%, baseline age= 52.3 [35.2-64.6] years old). Over follow-up, 2.96% suffered from 30-day all-cause mortality. Univariable logistic regression showed that aspirin use was associated with lower odds of severe COVID-19 in the propensity score-matched cohort (odds ratio [OR]: 0.33, 95% confidence interval [CI]: [0.18, 0.6];P=0.0003). This association remained significant following adjustment for significant confounders (OR= 0.33, 95% CI= [0.18, 0.59], P= 0002).ConclusionAspirin use was associated with lower odds of severe outcomes in COVID-19.Conflict of InterestNone
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151 Figure 1Day after discharge from hospitalDid you feel well today?Please write yes or no.Weight, kg123456789101112131415161718192021222324252627282930 151 Table 1Baseline characteristicsBaseline characteristicsStandard Follow-UpN=9Intensive Follow-UpN=17Age (years)78 [69,81]74 [65,82]Gender [number of females (%)] 2 (22%)7 (41%)Rockwood Frailty Score (2 weeks pre admission) 3 [3,5]5 [3,5]Left Ventricular Systolic Function (%)Preserved 34%Mildly impaired 11%Moderately impaired 33%Severely impaired 22%Preserved 35%Mildly impaired 12%Moderately impaired 18%Severely impaired 35%NTproBNP ng/L4772 [2883,4859]9 88 [4333,14876]eGFR on discharge, ml/min/1.73m246 [35,63]51 [30,82]Comorbidity Number (in addition to HF)3 [2,4]5 [3,6]SBP, mmHg108 [106,111]110 [103,120]Number of people known COVID positive (%)0%6%Descriptive statistics are expressed as Median [IQR] or N (%).Abbreviations: eGFR: Estimated Glomerular Filtration Rate, HF: Heart failure, IQR: Inter-Quartile Range, NTproBNP: N-terminal prohormone of brain natriuretic peptide, SBP: Systolic Blood Pressure. 151 Table 2Effectiveness of intensive follow-upStandard Follow-UpIntensive Follow-UpDays alive and well out of hospital12 [8,25]22 [15,28]Days with weight recorded27 [14,30]27 [7,30]ACEi, ARB, or entresto (%)6 (67%)14 (82%)Beta-Blocker (%)8 (89%)16 (94%)% max. dose of Beta-Blocker 44 [25,53]50 [34,100]MRA%5 (56%)9 (53%)Dose of MRA, mg25 [25,25]25 [25, 25]SGLT2 inhibitor (on Dapaglifozin or empaglifozin) (%)5 (56%)14 (82%)Total number of Disease Modifying Agents (max 4)3 [2,4]3 [3,4]Descriptive statistics are expressed as Median [IQR] or N (%).Abbreviations: ACEi: Angiotensin Converting Enzyme Inhibitor, ARB: Angiotensin Receptor Blocker, IQR: Inter-Quartile Range, MRA: Mineralocorticoid receptor antagonist, SGLT2 inhibitors: Sodium-glucose cotransporter-2 inhibitors.Conflict of InterestNone
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BackgroundOutcomes of patients hospitalized for cardiogenic shock during the midst of the COVID-19 pandemic in the United States have yet to be well described. This study aimed to examine if the COVID-19 pandemic led to gender differences in in-hospital outcomes, length of stay, and total hospital charges.MethodsData was extracted from the National Inpatient Sample database for the calendar year 2020. Patients who were admitted with a principal diagnosis of cardiogenic shock (R57.0) were identified using relevant International Classification of Disease, and Clinical Modification codes. The key outcomes of mortality, use of mechanical ventilation, use of mechanical circulatory support, hemodialysis, vasopressors use, length of stay, and total hospital charges were then accessed.ResultsThere were 2,670 hospitalizations for a principal diagnosis of cardiogenic shock in 2020, of which 955 were females. After adjusting for age, race, hospital bed size, hospital location, hospital teaching status, insurance status, income level, and Elixhauser comorbidities;we found that females admitted with cardiogenic shock were more likely to require mechanical ventilation (aOR 1.54, 95% CI 1.02- 2.34), but had no difference in mortality, vasopressor use, mechanical circulatory support use, hemodialysis initiation, length of hospital stay and total hospital charges relative males.ConclusionOur study found that females admitted for cardiogenic shock during the first year of the pandemic had significantly higher rates of mechanical ventilation but no difference in other outcomes. Further studies are needed to investigate the effect of COVID-19 on the outcomes of female patients admitted for cardiogenic shock.Conflict of InterestNone
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BackgroundRheumatologic patients treated with Rituximab (RTX) are at higher risk of severe COVID-19 and death. The B-cell depletive treatment significantly affects B cell functions involved in anti-SARS-CoV-2 response, leading to relevant impacts on the clinical and serological course of infection, long-term immunity, and vaccine responses. In light of these observations, pre-exposure prophylaxis (PrEP) of COVID-19 with Tixagevimab and Cilgavimab (TGM/CGM) was recently approved in Italy for all patients treated with RTX in the previous year, independently of their serological status against SARS-CoV-2.ObjectivesWe aimed to evaluate the efficacy and safety of TGM/CGM in a single-centre cohort of rheumatologic patients treated with RTX.MethodsFrom October 2022, all patients who had been treated with RTX in the previous 12 months and who underwent clinical assessment at our rheumatologic tertiary centre were screened for eligibility to PrEP of COVID-19 with TGM/CGM. According to the indications of the Italian Medicines Agency (AIFA), we excluded subjects with major cardiovascular risk factors and/or coagulation abnormalities;those who reported a previous allergic reaction to any anti-COVID19 vaccine were referred to an allergologist for an evaluation before TGM/CGM administration. Patients who agreed to be treated with TGM/CGM signed an informed consent. Clinical and demographic features were collected at baseline, and follow-up phone assessment was performed the day after and 1 month after TGM/CGM administration, to assess treatment tolerability and new COVID-19- related events. A descriptive analysis was performed.ResultsFrom 1 October 2022 to 31 December 2022, 90 subjects were screened for eligibility to TGM/CGM. Among them, 11 were excluded for contraindications due to comorbidities and 55 refused TGM/CGM administration. Among patients who agreed to receive PrEP of COVID-19, 21 received TGM/CGM before 31 December 2022 and 3 were scheduled for January2023. Patients treated with TGM/CGM had a mean age of 54 years (standard deviation: 17) and 19 (90.5%) were female;9 were affected by rheumatoid arthritis and 12 by other rheumatologic diseases (3 systemic lupus erythematosus, 2 systemic sclerosis, 1 Sjögren syndrome, 1 juvenile idiopathic arthritis, 3 anti-synthetase syndrome, 2 vasculitides). Most of them had completed the vaccination schedule against COVID-19 (19, 90.5%) and 9 (42.8%) reported an infectious event by SARS-CoV-2 in the previous year. One month after TGM/CGM administration, no patient reported adverse events related to TGM/CGM nor COVID-19 related symptoms.ConclusionPrEP of COVID-19 with TGM/CGM was well tolerated in our population of rheumatologic patients treated with RTX in the previous year and no COVID-19 related symptoms were observed in the month of follow-up after TGM/CGM administration. Future observations may provide further data on long-term efficacy of TGM/CGM in preventing COVID-19.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsMaria Manara Speakers bureau: Novartis, Angelini, Consultant of: Lilly, MSD, Manuel Sette: None declared, Laura Giudice: None declared, Martina Biggioggero: None declared, Nicoletta Del Papa Speakers bureau: Janssen, Boehringer-Ingelheim, Actelion, Ennio Giulio Favalli Speakers bureau: AbbVie, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, Consultant of: AbbVie, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, Maria Gerosa: None declared, Francesca Ingegnoli: None declared, Roberto Caporali Speakers bureau: AbbVie, Amgen, BMS, Celltrion, Fresenius, Galapagos, Janssen, Lilly, Novartis, Pfizer, UCB, Consultant of: AbbVie, Fresenius, Galapagos, Lilly, Novartis, Pfizer, UCB.
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The medical documentation (n = 146912) introduced into the system "Regional fragment of the unified state information system in the field of healthcare” of Saint Petersburg for 2019–2021 was analyzed. To evaluate the mortality of patients due to heart failure, all deceased patients from 2019 to 2021 in Saint Petersburg (n = 192133) were taken as a basis, and based on a thorough study of medical documentation, patients who died from cardiovascular diseases and because of heart failure were singled out separately. The total mortality from all causes in Saint Petersburg in 2019 was 53025 people;in 2020, 66468 people;and in 2021, 72640 people. The analysis of mortality due to cardiovascular diseases from 2019 to 2021 showed an upward trend of 20.1% over the 3-year period of data analysis. When analyzing the prevalence of heart failure among deceased patients, an increase of 129.4% was noted over this period. The obtained results of the prevalence, mortality, and mortality of patients due to heart failure on the example of a megalopolis are the most relevant at the current time;they indicate a steady increase in the number of patients suffering from heart failure with an increase in the burden on the city's healthcare system. Simultaneously, there is insufficient continuity in the provision of medical care to patients suffering from heart failure, which is because of not only a shortage of medical personnel at all stages of medical care but also insufficient compliance of patients who either do not want to be treated or cannot continue treatment. Moreover, a significant disconnect was found in the continuity of medical care at the stages of pre-hospital and hospital treatment, as well as further outpatient follow-up of patients suffering from heart failure in the metropolis. All this leads to a significant increase in the mortality and mortality of patients suffering from heart failure, despite all the existing modern effective drug therapies. It appears critical to create a unified register platform for recording patients with heart failure, which will allow for a more accurate understanding of epidemiological aspects, the solution of which will improve the quality of medical care, identify the need for the crucial medicines, and reduce mortality, and mortality rates due to heart failure. All rights reserved © Eco-Vector, 2022.
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IntroductionHeart Failure (HF) carries significant mortality and morbidity, especially due to comorbidities such as Atrial Fibrillation (AF). Previous work illustrates that mitochondrial dysfunction underpins the pathophysiology of both HF and AF, including decreased Adenosine TriPhosphate (ATP) production, Ca2+ mishandling, oxidative stress and elevated apoptosis. In addition to these problems, recent work suggests the Mitochondrial Permeability Transition Pore (MPTP) in ventricular cardiomyocytes may become sensitised to Ca2+ during HF, leading to increased apoptosis. Nevertheless, the role of mitochondrial dysfunction has not been investigated in the atria. In this study, we investigated the role of Ca2+ sensitivity of the MPTP and mitochondrial aerobic capacity in atrial muscle of the failing heart.MethodsRight atrial appendage and right ventricular free wall were dissected from 15 sheep representing an ovine model of tachycardia-induced HF. The tissue was subsequently homogenized and differentially centrifuged, yielding isolated mitochondria. Respiratory function was measured using a respirometer, with the electron transport system (ETS) selectively probed through addition of various substrates stimulating differing ETS complexes. A Calcium Retention Capacity (CRC) assay determined MPTP Ca2+ sensitivity, which involved Ca2+ titrations onto isolated mitochondria containing a Ca2+-sensitive fluorescent dye. An increase in fluorescence marked MPTP opening.ResultsAerobic capacity was not affected by HF, but an increase in ventricular leak respiration was statistically significant (p=0.0140). HF reduced atrial mitochondrial efficiency by 68% (p=0.0063) but did not affect maximal mitochondrial respiration. There was no significant effect of HF or tissue-type on MPTP Ca2+ sensitivity and mitochondrial Ca2+ buffering capacity.ConclusionOur data suggests HF affects atrial and ventricular mitochondrial respiratory function asymmetrically, with HF affecting atrial mitochondrial efficiency and ventricular leak respiration. The COVID-19 pandemic hindered this research project;however, it provides rationale on the unequal effect of HF on mitochondrial function across the atria and ventricle. Future research should therefore consider incorporating atrial samples when assessing potential HF therapies.Conflict of InterestNil
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209 Figure 1Kaplan-Meier curves displaying cumulative all-cause mortality[Figure omitted. See PDF]Conflict of InterestNo conflicts of interest
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Mervyn George Bishop/Fairfax Media/Getty Images Peter Sleight, a professor at Oxford University, helped to transform heart attack treatment and prevent cardiovascular disease with angiotensin converting enzyme inhibitors and statins. Isis methodology influenced the design of studies into other conditions, including the Recovery trial, which showed that dexamethasone reduces covid-19 mortality. [...]unlike many eminent men, he was able, endearingly, to laugh at himself—for example, when medical students lampooned him as Professor BA Flight after he had flown to Tokyo for the day. In the last 10 years of his life, he generated global media interest after demonstrating with his Italian colleague Luciano Bernardi that certain musical rhythms lowered blood pressure.
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Objectives Human leukocyte antigens (HLA) are highly diverse transmembrane proteins that present viral peptides to T cells and launch pathogen-specific immune responses. We aim to investigate the correlation between HLA evolutionary divergence (HED), a surrogate for the capacity to present different peptides, and the outcomes of SARS-CoV-2 infection in a cohort from the St. Louis Metropolitan area. Methods We enrolled adult patients with SARS-CoV-2 infection confirmed by RT-PCR who were hospitalized at two tertiary hospitals in St. Louis between March and July 2020. Genomic DNA was extracted from peripheral blood and genotyped by next-generation sequencing (NGS). HLA alleles were assigned based on key-exon sequences (G group) and limited to the 2-field resolution. HED was calculated by Grantham distance, which considers the difference in composition, polarity, and molecular volume between each pair of amino acids from maternal and paternal HLA. The HED score was obtained for HLA class I (HLA-A, -B, and -C) genotypes using the HLAdivR package in R. Clinical data were collected retrospectively from electronic medical records. A poor outcome was defined as an admission to the intensive care unit (ICU), a need for mechanical ventilation, or death. A favorable outcome was defined as the absence of the above poor outcomes. Results A total of 234 patients were enrolled in this study, 96 being females (41%). The median age and BMI were 66 years old and 28.30 kg/m2, respectively. African Americans comprised 71.4% of the cohort. Only 19 patients (8.1%) presented with no comorbidity;the rest had one or more comorbidities, with cardiovascular diseases being the most common. A total of 137 (58.5%) patients had poor outcomes from SARS-CoV-2 infection, while 97 (41.5%) patients had a favorable outcome. We detected a significant association between higher HLA-B HED and favorable outcomes, with each 1-point increase in HLA-B HED associated with 8% increased probability for the composite endpoint (OR 1.08, 95% CI=1.01-1.16, P = 0.04). The HED scores calculated for HLA-A or HLA-C were not significantly different between patients with favorable or poor outcomes. In a multivariate logistic regression analysis, increased HLA-B HED score, younger age, and no comorbidity were independently associated with favorable outcomes (P = 0.02, P = 0.01, and P = 0.05, respectively). Conclusion Our study shows a significant correlation between lower HLA-B HED scores and poor outcomes after SARS-CoV-2 infection. This finding suggests that maximizing the presentation of diverse SARS-CoV-2 peptides by HLA-B alleles may improve the clearance of SARS-CoV-2. Further studies are warranted to understand the functional and mechanistic implications of this finding.
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BackgroundVaccinations comprise a part of the antenatal care of pregnant women, including patients with systemic lupus erythematosus (SLE) who are at increased risk of adverse pregnancy outcomes (APOs). While COVID-19 vaccination has been shown to be safe in patients with SLE, data on vaccine-associated adverse events (AEs) during the antenatal and lactation period are scarce or lacking.ObjectivesTo investigate the association between COVID-19 vaccination and AEs in pregnant SLE patients.MethodsA total of 9201 complete responses were extracted on June 21st, 2022 from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) 2 database, a global e-survey involving 157 collaborators from 106 countries. Among respondents, 6787 (73.8%) were women. We identified 70 (1.1%) women who were exposed to at least one COVID-19 vaccine dose during pregnancy, among those 11 with SLE. Delayed onset (>7 days) vaccine-related AEs were extracted and triangulated with disease activity, treatment changes due to flare after vaccination, and COVID-19 infections in vaccinated pregnant women with SLE. Additionally, information on health-related quality of life and physical function was recorded using PROMIS at the time of survey completion.ResultsThe age of patients ranged from 28 to 39 years;5/11 women were of Asian origin. None of these patients reported major vaccine AEs, including four patients with self-reported active SLE prior to the vaccination. None of them reported any change in the status of their autoimmune disease, and no hospitalisation or special treatment was recorded. Six women experienced minor vaccine AEs;two of them had active disease prior to vaccination. Four patients reported COVID-19 infection;two of them while they were pregnant and post-vaccination and two prior to pregnancy and vaccination. All four patients experienced symptoms of their disease, but no overt SLE flare was reported. At the time of survey completion, all patients reported their general health as being good to excellent in all aspects evaluated. Importantly, no APOs were reported.None of the patients reported thrombotic events post-vaccination, which provides some reassurance regarding COVID-19 vaccination in a patient population with a high risk for cardiovascular comorbidity and thrombosis, especially in the presence of antiphospholipid antibodies or in patients diagnosed with the antiphospholipid syndrome, a considerable portion within SLE populations. Moreover, it was reassuring to note an absence of association between experienced vaccine AEs and active disease prior to vaccination. Although minor AEs were common, they did not impair daily functioning, and the symptoms resolved in all patients after a median of 3 (IQR: 2.5–5.0) days.ConclusionOur report adds relevant evidence concerning the sensitive issue of COVID-19 vaccine AEs and flares in SLE patients during the antenatal and lactation period. Despite the small sample size, the findings provide some reassurance and can contribute to informed decisions regarding vaccination in patients with SLE and high-risk pregnancies due to their background autoimmune disease. Based on the present data, the risk/benefit ration of COVID-19 vaccination appears favourable, with vaccines both providing passive immunisation to the fetus and active immunisation to the mother with no signals of exacerbation of the mother's autoimmune disease.Figure 1.Timeline showing COVID-19 vaccination and vaccination-related minor adverse events in relation to gestational and post-partum periods in eleven pregnant/lactating women with systemic lupus erythematosus.[Figure omitted. See PDF]AcknowledgementsThe authors thank all survey respondents, as well as patient associations and all members of the COVAD study group for their invaluable role in the data collection.Disclosure of InterestsNefeli Giannopoulou: None declared, Latika Gupta: None declared, Laura Andreoli: None declared, Daniele Lini: None declared, Elena Nikiphorou: None declared, Rohit Aggarwal Grant/research support from: R.A. has a consultancy relationshi with and/or has received research funding from Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, Merck, Galapagos, Actigraph, Scipher, Horizon Therapeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio., Vikas Agarwal: None declared, Ioannis Parodis Grant/research support from: I.P. has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis, and F. Hoffmann-La Roche AG.
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BackgroundPatients with autoimmune rheumatic diseases (ARDs) under moderate/severe immunosuppression are considered a high-risk population to develop severe Covid-19 infection.ObjectivesThe aim of our study was to describe the clinical characteristics and the outcome of patients with ARD who contracted a Sars-Cov-2 infection.MethodsAmong patients with ARD being followed in our tertiary outpatient rheumatology clinic, we retrospectively identified those infected with SARS-CoV-2 between the beginning of the pandemic and August 2022. Patients' medical files were reviewed for demographics (age, gender and comorbidities) and disease-related characteristics, as well as coronavirus disease (COVID-19) characteristics, including vaccination status, treatment, and outcomes (covid-19 severity, hospitalization, death).ResultsA total of 209 cases of ARD patients with confirmed Covid-19 infection were recorded. Most of them were women (62.7%), with a mean age of 52.4± 13.8 years. The most prevalent ARDs were seronegative spondyloarthropathies (28.7%), systematic lupus erythematosus (21.5%), rheumatoid arthritis (16.5%), and systemic sclerosis (11.5%). More than half of the patients received corticosteroids (57.8%), while the most frequently used immunosuppressants were hydroxychloroquine (30.9%), TNF inhibitors (26.5%), mycophenolate mofetil (24.0%), methotrexate (19.1%) and rituximab (15.2%). One hundred and fifty-eight (76%) patients were either on remission or had mild disease activity. Most of the patients (131/209) had at least one comorbidity, more commonly arterial hypertension (48.5%) and pulmonary disease (45.2%). Most of the patients were vaccinated against Sars-Cov-2 (73.7%), either with two doses (38.0%), three doses (57.0%) or four doses (5.0%) of mRNA-based vaccines. The big majority of the patients (83.3%) were asymptomatic or had mild Covid-19 disease. About half of the patients (53.1%) reported to have received Covid-19 treatment. Thirty-two of them (15.3%) needed hospitalization, and five death cases were reported overall. Among the demographic characteristics, age (p<0.0001 for hospitalization) and comorbidities were associated with worse covid-19 outcomes. In particular, cardiovascular disease (OR 5.37, p=0.001 for covid-19 severity, OR 6.89, p=0.001 for hospitalization), pulmonary disease (OR 3.02, p=0.006 for hospitalization), and obesity (OR 3.46, p=0.044 for hospitalization) had the stronger associations. Non-vaccination status was also associated with a higher risk for hospitalization (OR 2.68, p=0.015). In relation to ARD-related factors, treatment with rituximab (OR 4.11, p=0.002 for hospitalization), systemic sclerosis diagnosis (OR 3.45, p=0.03 for Covid-19 severity) and myositis diagnosis (OR 4.91, p=0.033 for hospitalization) were associated with worse Covid-19 outcomes. On the other hand, spondyloarthropathies appear to be negatively associated with Covid-19 severity (OR=0.27, p=0.035).ConclusionAccording to our study, most ARD patients recovered uneventfully from Covid-19. However, there are several indications that we should be vigilant for patients who remain unvaccinated, are older, have a systemic sclerosis or myositis diagnosis, and/or receive intense immunosuppressive regiments such as rituximab.References[1]Papagoras C, Fragoulis GE, et al. Better outcomes of COVID-19 in vaccinated compared to unvaccinated patients with systemic rheumatic diseases. Ann Rheum Dis. 2021 Nov 10.[2]Strangfeld A, Schäfer M, et al. Factors associated with COVID-19-related death in people with rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance physician-reported registry. Ann Rheum Dis. 2021 Jul;80(7):930-942.Table 1.N=209ARD Diagnosisn (%)Rheumatoid arthritis34 (16.3)Seronegative spondyloarthropathies60 (28.7)Systemic lupus erythematosus45 (21.5)Systemic sclerosis24 (11.5)Sjogren's syndrome15 (7.2)Vasculitis19 (9.1)Myositis9 (4.3)Other3 (1.4)Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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IntroductionRecent results from the IRONMAN trial add to previous data and demonstrate that correction of iron deficiency in patients with heart failure, with high dose IV iron can improve quality of life, and reduce the risk of heart failure hospitalisation (by around 25% in meta-analysis). Yet there are theoretical risks that IV iron administration may increase the risk from bacterial infection. A meta-analysis in 2021 (across many clinical indications) suggested an excess risk of infections with IV iron but noted most trials did not pre-specify infection as an end point, with risk of reporting bias. To answer this important question hospitalisation for infection or death due to infection were pre-specified safety endpoints in IRONMAN.MethodsIRONMAN was a prospective, randomised open-label, blinded endpoint (PROBE) event-driven trial of IV ferric derisomaltose (FDI) and usual care versus usual care alone in patients with heart failure (LVEF ≤45% ) and iron deficiency (ferritin <100 µg/L and/or TSAT <20%, provided ferritin ≤400 µg/L). Patients were enrolled if they had a current or recent hospitalisation for heart failure or elevated natriuretic peptide plasma concentration. Every four months, IV iron was administered if either ferritin was <100 µg/L or TSAT was <25% (provided ferritin ≤400 µg/L). All hospitalisations and deaths were adjudicated blindly. Given that a large part of the trial was conducted during the COVID-19 pandemic, we also evaluated COVID-19 related SAEs.Results1137 patients (26.4% women) with median (IQR) age 73 (63 to 79) years were recruited by the Ironman Study Group between Aug 2016 and Oct 2021 across 70 UK sites. Median (IQR) follow-up was 2·7 (1·8 to 3·6) years. 97% of patients consented to record linkage to national databases of deaths and hospital discharge summaries, thereby ensuring investigators were aware of all potential events. There were a similar number of hospitalisations due to infection for those assigned to ferric derisomaltose (175) and usual care (213) (p = 0.16) and infection related death (34 and 28, respectively, p = 0.43). When considering first events of hospitalisation for infection or infection death there were 120 (21.1%) events for those randomised to IV FDI and 146 (25.7%) for the usual care arm (figure). There were fewer patients with COVID related SAEs in those randomised to IV FDI (12) as compared with usual care (30), HR (95% CI) 0.40 (0.20, 0.78). p=0.007. For deaths attributed to COVID-19, 4 were seen in the IV FDI arm and 8 in the usual care arm: HR 0.51 (0.15, 1.68) p=0.27.ConclusionsThere was no excess risk of infection related hospitalisation or death in patients receiving IV ferric derisomaltose. Fewer COVID-19 related SAEs were seen in patients receiving IV FDI. Given that iron plays an important role in the T and B cell response to vaccination, further analysis needs to be done in this area.Conflict of InterestHonorarium for education from Pharmocosmos
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106 Table 13 MonthsRhythmAmiodarone (n=159)No Amiodarone (n=223)SR126141AF3382 106 Table 212 MonthsRhythmAmiodarone (n=113)No Amiodarone (n=125)SR5934AF5491Conflict of InterestNil
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BackgroundGCA is a critically ischemic large vessel vasculitis, varying in extent, severity and outcomes, hence requires disease stratification using clinical, laboratory and imaging parameters, for targeted management. Although DMARDs are used, the effectiveness in real life, such adjuvants remain un-elucidated. We performed a prospective, multi centre cohort study of new GCA stratified into remitting, relapsing, refractory, ischemic disease.ObjectivesWe assessed prognostic factors and compared critical outcomes such as remission with glucocorticoid (GC) monotherapy versus GC plus DMARDs in the first 12 months.MethodsHAS GCA study (1) recruited consecutive patients with new onset GCA from 7 centres (UK, Italy, Spain, Netherlands). diagnosis was confirmed used a modified GiACTA criteria at 6 months follow up. All underwent ultrasound (bilateral common, parietal, frontal temporal arteries, and axillary arteries) using accepted standard cut-off values [2]. GCA patients had US at baseline,1,3,6,12 months and halo count (HC) and Halo score (Temporal TAHS, axillary AAHS, total THS) assessed [3]. The primary outcome- remission at 12 months (absence of signs/symptoms, CRP<5 mg/dl, prednisolone < 5 mg daily). Results are reported as descriptive statistics.Results229 participants included in the study (GCA- 84 (36.68 %) (Figure 1). Study recruited during Covid pandemic,73 completed,11 lost to follow-up (died -7, withdrawn-4). The deceased/withdrawn patients (compared to completers) were older (80 v74 yrs, p=0.018), preponderantly male (73% v 36%, p=0.043) with visual symptoms (91% v 49%, p=0.010) partial/total sight loss (55% v 21%, p=0.024), lower CRP (21 v 68, p=0.061) and ESR (42 v 62, p= 0.317).Of 73 completers 36 required early DMARDs (<12 weeks) for refractory/relapsing/ischemic/GC related AEs. This group had more LV involvement (50% v 11%, p=0.0003), Remission attained at 12 months 32/36 (89%) in DMARD group was comparable to the remitting GC monotherapy group 33/37 (89%) with comparable cumulative GC doses (Figure 1, Table 1).At 12-months follow up, median TAHS, AAHS and THS reduced from 13 to 3, 12 to 9 and 21.5 to 12, respectively.ConclusionOur study suggests, elderly males with visual symptoms, sight loss, lower CRP are a high-risk group with increased mortality within GCA. Difficult to treat disease is seen in half of all patients especially with LV involvement. This group responds well to early DMARD use achieving remission comparable to the remitting group at 12 months. Current therapies fail to achieve remission in 9.5 % of cases. HS and HC show significant improvement mirroring clinical outcomes during first 12 months of therapy.References[1]Sebastian A et al. BMC Rheum. 2020[2]Schafer VS et al. Rheumatology 2017[3]van der Geest KSM et al. ARD 2020Table 1.comparison between the DMARD-used group and only GC group in all the GCA completed the 12 months follow upPatients' characteristicsGCA with completed follow-up (n=73)GCA treated with DMARD=36GCA not treated with DMARD=37Age, median (range) years73.5 (60-89)76 (60-89)Sex, Females, n (%)23 (64)24 (65)US halo score (HS)/IMT median (range)Temporal artery HS11 (0-23)13 (1-22)Axillary artery HS12 (0-21)12 (0-18)Axillary artery IMT (mm)0.77 (0.33-2.6)0.82 (0.39-1.21)Total HS22.5 (2-41)21 (5-40)Clinical features, n (%)Temporal headache25(69)30 (81)Scalp tenderness17 (47)19 (51)Jaw & Tongue claudication22 (61)24 (65)Polymyalgic symptoms21 (58)13 (35)Constitutional symptoms21 (58)18 (49)Any visual disturbance15 (42)21 (57)Partial or complete vision loss8 (22)7 (19)History of PMR6 (17)3 (8)Exam findings, n (%)Temporal artery abnormality24 (67)30 (81)AION/ CRAO8 (22)6 (16)Ocular nerve palsy1 (3)3 (8)Lab markers at baseline, median (range)CRP mg/dL,72.2 (6.4-292)59 (6-206)ESR mm/hr67 (9-130)57 (2-120)GC treatment, median (range)GC starting dose, (baseline)45 (0-60)50 (0-60)GC dose at 12m,5 (0-25)2.5 (0-10)Cumulative GC dose at 12m4627.5 (2600-10260.5)4622.5 (944-10737.5)Remission with prednisolone dose ≤5 mg at 12m, n (%)32 (89)33 (89)Acknowledgements:NIL.Disclosure of InterestsBhaskar Dasgupta Consultant of: Roche, Chugai, Sanofi, Grant/research support from: Roche, Sanofi, AbbVie, and GlaxoSmithKline, Kornelis van der Geest Speakers bureau: Roche, Grant/research support from: AbbVie, Alessandro Tomelleri: None declared, Pierluigi Macchioni: None declared, Giulia Klinowski: None declared, Carlo Salvarani: None declared, Abdul Kayani: None declared, Mohammad Tariq: None declared, Diana Prieto-Peña: None declared, Edoardo Conticini: None declared, Muhammad Khurshid: None declared, Sue Inness: None declared, Jo Jackson: None declared, Alwin Sebastian: None declared.
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BackgroundLong-term glucocorticoid (GC) exposure leads to systemic bone loss and fracture. In addition, GC is known to increase white blood cell (WBC) amount and change the distribution of differential count (DC). Neutrophil-to-Lymphocyte ratio (NLR) has been studied as an optimal marker of subclinical inflammation, predicting the prognosis of cardiovascular diseases, cancers and even covid-19 infection. For patients under long-term GC exposure, the hemogram change might be a potential parameter to predict prognosis.ObjectivesThis pilot study aims to investigate if GC related WBC-DC change, including NLR, is associated with future fractures during 3 years follow-up.MethodsThis retrospective study is based on a registry, conducted in Kaohsiung Chang Gung Memorial Hospital, Taiwan, from September 2014 till April 2021, aimed to monitor bone mineral density (BMD) changes and fractures in patients with autoimmune diseases. All recruited patients were followed at least 3 years and took X-ray images annually to capture new fragility fracture, including morphometric vertebral fractures. We screened participants who used GC continuously at least 3 months before the index day. We recorded the complete blood count (CBC) and WBC-DC values at least twice during the period of 3 months before and after the index day, and excluded patients who were febrile, under infection status, diagnosed as cancers or cardiovascular diseases at the index day. The NLR was calculated by the absolute neutrophil count divided by absolute lymphocyte count individually.ResultsA total of 346 participants were enrolled in current study, and 101 (29.2%) suffered from new fragility fracture in 3 years. Among patients with fracture and non-fracture, conventional fracture risk factors, such as age, BMD, and previous fracture remained significantly different, while the WBC revealed no difference (Table 1). Nevertheless, the absolute neutrophil and lymphocyte count were significantly higher and lower in the fracture group, respectively, and no difference in the monocyte, eosinophil, and basophil count. We compared different WBC ratio, and NLR is significantly higher in the fracture group, providing the odds ratio of 1.24 (95% confidence interval 1.07-1.44, p=0.005). Figure 1 showed that the observed fracture risk raised as the NLR values increased.ConclusionIn patients under long-term GC, NLR might be a helpful marker to predict fracture, and higher NLR indicates higher fracture risks.Figure 1.Observed fracture rate is associated with baseline NLR[Figure omitted. See PDF]Table 1.Demographic characteristics of enrolled patients on long-term glucocorticoid.Fracture N=101No-Fracture N=245p-valueAge63.7 ± 9.056.5 ± 9.6<0.001*Sex(women)89(88.1)210(85.7)0.55BMI24.1 ± 3.923.4 ± 3.90.14Previous Fracture64(63.4)55(22.4)<0.001*Total hip BMD0.738 ± 0.1330.790 ± 0.1220.001*Femoral neck BMD0.575 ± 0.1130.626 ± 0.109<0.001*Lumbar BMD0.841 ± 0.2000.855 ± 0.1500.49WBC7.3 ± 2.16.9 ±1.70.14Hemoglobin12.8 ± 1.512.9 ± 1.40.33Platelet239.2 ± 64.7247.9 ± 71.40.30Neutrophil67.3 ± 9.764.3 ± 9.70.009*Lymphocyte24.3 ± 8.726.6 ± 9.50.04*Monocyte6.2 ± 1.86.3 ± 1.60.52Eosinophil1.8 ± 1.81.9 ± 1.30.77Basophil0.4 ± 0.20.4 ± 0.20.18NLR (Neutrophil to lymphocyte)3.3 ± 1.72.8 ± 1.40.004*NMR (Neutrophil to monocyte)11.9 ± 4.511.0 ± 3.60.04*LMR (Lymphocyte to monocyte)4.2 ± 1.74.5 ± 1.90.20AcknowledgementsThis work was supported by funding grant CMRPG8J0331 from the Chang Gung Memorial Hospital (https://www.cgmh.org.tw).Disclosure of InterestsNone Declared.
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Based on the assessment of factors that contribute to a new coronavirus infection, the risk of complications, mortality, and lethality from it in the Armed Forces of the Russian Federation were analyzed. A detailed timeline of the development of the coronavirus pandemic in the Russian Federation has been demonstrated, showing indicators of peak and overall morbidity and mortality and prevailing strains of a new coronavirus infection, depending on the waves of the pandemic. The study evaluated the features of the course of a new coronavirus infection in the Eurasian region using data from the international register "Analysis of the dynamics of comorbid diseases in patients infected with severe acute respiratory syndrome-2 coronavirus”. Modern ideas about the main pathogenetic mechanisms of involvement of the circulatory system, which underlie the development of a severe course, mortality, and lethal outcomes, are outlined. The study also presented the concept of metabolic and hemodynamic insufficiency, which justifies the inability of the desynchronized circulatory system and systems of vascular homeostasis and hemostasis to restore the previous level of functioning after a new coronavirus infection. The possibilities of carrying out differentiated anti-epidemiological measures, including the use of information technologies, aimed at reducing the spread of a new coronavirus infection, were evaluated. The mortality and mortality from a new coronavirus infection in the Armed Forces of the Russian Federation, including the effect of a new coronavirus infection on an increase in the incidence of non-communicable diseases in military personnel of different age groups, were presented. The study also considered issues of the need to introduce a rehabilitation strategy to correct conditions that occur after a new coronavirus infection, reduce the risk of subsequent mortality and lethality, and reduce it in the long term. All rights reserved © Eco-Vector, 2022.
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A problem of the novel coronavirus infection pandemic is the absence of specific biomarkers, the determination of which would make it possible to assess the likelihood of a severe disease course, development of complications, immediate and long-term consequences, and effective etiotropic (antiviral) therapy. The severity of the novel coronavirus infection depends on various factors such as the initial state of health, immune status, age, smoking status, concomitant cardiovascular diseases, and diabetes mellitus. However, a severe disease course is also observed in patients without the aforementioned risk factors. The development of the disease and its complications depends on sex and geographical identity. Angiotensin-converting enzyme 2 (ACE2), associated by gene-gene interaction with ACE, plays a main role in the pathogenesis of the penetration of severe acute respiratory syndrome-2 coronavirus into the cell. The main body of information on this problem is represented by systematic meta-analyses and results of single-center cohort studies, which offer insufficient information to unequivocally assert the associations of ACE and ACE2 gene polymorphisms with pathological changes in the circulatory system during and after a new coronavirus infection. Differences in the incidence of ACE and ACE2 alleles may explain the differences between susceptible populations and/or response to the severe coronavirus infection. The above studies were carried out on the effect of the coronavirus in the initial period of the pandemic. For a more complete molecular genetic picture of the influence of polymorphism, persons with different strains of the coronavirus must be considered. In addition, no data are available regarding the expressions of ACE and ACE2 genes in response to a coronavirus infection. Moreover, the identification of the polymorphic variants of the genes of the renin–angiotensin–aldosterone system and ACE2 associated with a high risk of developing and worsening cardiovascular diseases may be one of the promising areas for the early diagnosis and prevention of post-COVID-19 changes. Therefore, all scientific interest research is aimed at studying genetic factors, such as single nucleotide polymorphisms that affect susceptibility to infection, severity of the disease course, and development of circulatory system consequences. In general, polymorphic variants of ACE and ACE2 and their interaction will help us understand this problem and systematize knowledge for further research in this area. All rights reserved © Eco-Vector, 2022.
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201 Table 1Demographics of cohortVariableCategory/SummaryNegativePositiveOverallORP-value95%CI low95%CI high3043(79.7%)777(20.3%)3820AgeMean/SD21.19/6.7920.93/6.0721.12/6.640.9800.2580.9451.015Median (Q1-Q3)18(15, 27)19(16, 25)18(15, 27)Min-Max14-3614-3614-36BMIMean/SD23.34/4.8924.12/4.9023.48/4.831.068<.0011.0351.103Median (Q1-Q3)22.44(19.9, 25.9)23.39(20.5, 26.8)22.60(20.06, 26.03)Min-Max13.36-55.2514.40-45.9013.36-55.25SexWomen1107(36.3%)250(32.4%)1357 (35.5%)1Men1935 (63.5%)521(67.6%)2456 (64.3%)1.2020.0321.0161.421EthnicityWhite2789(91.65%)707(90.99%)3496(91.5%)Asian89(2.92%)23(2.96%)112 (2.93%)Black53(1.74%)11(1.42%)64 (1.68%)Other112(3.68%)36(4.63%)148 (3.87%)BAME vs. White1.0870.5550.8241.434Group Sedentary495(16.24%)112(14.53%)607 (15.89%)1typeRecreational1331(43.67%)302(39.17%)1633 (42.76%)0.7720.0030.6500.916Elite1222(40.09%)357(46.30%)1579 (41.35%)0.7620.0240.6020.965MET A (0 METs)440 (14.44%)105(13.62%)545(14.27%)1CategoryB (<500 MET-min/week)91(2.99%)12(1.56%)103 (2.70%)0.5540.0700.2921 049C (500-999 MET-min/week)128(4.20%)25(3.24%)153 (4.01%)0.8200.4170.5081.324D (1000-1499 MET-min/week)149(4.89%)37(4.80%)186 (4.87%)1.0780.7220.7121.633E (>1500MET-min/week)2240(73.49%)592(76.78%)2832 (74.16%)1.1220.3300.8901.414 201 Table 2The effects of demographics, physical activity, and symptoms on disease durationORp-value95%CI low95%CI highMen vs. Women0.561<0.0010.4180.753MET categoriesCATEGORY B vs. A1.4360.5490.4414.679CATEGORY C vs. A0.8650.7430.3642.056CATEGORY D vs. A0.5440.0890.2691.098CATEGORY E vs. A0.5320.0020.3560.795Recreational vs. Elite athlete1.698<0.0011.2602.288Sedentary vs. Elite athlete2.255<0.0011.4913.411Sedentary vs. recreational1.3280.185.8732.019Shortness of breath (YES vs. NO)3.558<0.0012.6144.842Chest pain (YES vs. NO)2.341<0.0011.5093.630Chest tightness (YES vs. NO)2.733<0.0011.9143.902Palpitations (YES vs. NO)3.1370.0011.5616.305 201 Figure 1The effect of the available variables on the duration of the disease in COVID-19 positive participants[Figure omitted. See PDF]Conflict of InterestNone