Convalescent plasma for outpatients with early COVID-19

AbstractBackgroundConvalescent plasma (CP) for hospitalized patients with COVID-19 has not demonstrated clear benefits. However, data on outpatients with early symptoms are scarce. We aimed to assess whether treatment with CP administered during the first 7 days of symptoms reduced the disease progression or risk of hospitalization of outpatients.MethodsTwo double-blind randomized trials (NCT04621123, NCT04589949) were merged with data pooling starting when <20% of their predefined sample size had been recruited. A Bayesian adaptive individual patient data meta-analysis was implemented. Analyses were done with Bayesian proportional odds and logistic models, where odds ratios (OR)<1.0 indicate a favorable outcome for CP. Fourteen study sites across the Netherlands and Catalonia in Spain participated in the trial. The two studies included outpatients aged ≥50 years and diagnosed with COVID-19 and symptomatic for ≤7days. The intervention consisted of one unit (200-300mL) of CP with a predefined minimum level of antibodies. The two primary endpoints were (a) a 5-point disease severity scale (fully recovered by day 7 or not, hospital or ICU admission and death) and (b) a composite of hospitalization or death.ResultsOf 797 patients included, 390 received CP and 392 placebo. At baseline, they had a median age of 58 years, 1 comorbidity, symptoms for 5 days and 93% tested negative for SARS-CoV-2 S-protein IgG antibodies. Seventy-four patients were hospitalized, 6 required mechanical ventilation and 3 died. The OR of CP for an improved disease severity scale was 0.936 (credible interval (CI) 0.667-1.311). The OR for hospitalization or death was 0.919 (CI 0.592-1.416). The effect of CP on hospital admission or death was largest in patients with ≤5 days of symptoms (OR 0.658, 95% CI 0.394-1.085). CP did not decrease the time to full symptom resolution (p=0.62).ConclusionTreatment with CP of outpatients in the first 7 days of symptoms did not improve the outcome of COVID-19. The possible beneficial effect in patients with ≤5 days of symptoms requires further study.RegistrationNCT04621123 and NCT04589949 on https://www.clinicaltrials.govFunding sourceZONMW, the Netherlands, grant number 10430062010001.SUPPORT-E, grant number 101015756YoMeCorono, www.tomecorono.comThe Fight AIDS and Infectious Diseases Foundation with funding from the pharmaceutical company Grifols S.A

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OP0009 DERIVATION AND VALIDATION OF THE SCLERODERMA LUNG 3-STAGE INDEX (SL3SI), A NEW FUNCTIONAL INDEX FOR INTERSTITIAL LUNG DISEASE WITH PROGNOSTIC IMPLICATIONS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.5788 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 7.2-7

Author(s):

A. Santaniello ◽

C. Bellocchi ◽

L. Bettolini ◽

M. Cassavia ◽

G. Montanelli ◽

...

Keyword(s):

At Risk ◽

Interstitial Lung Disease ◽

Lung Disease ◽

Disease Severity ◽

Disease Duration ◽

Functional Model ◽

Severity Scale ◽

Predictive Capability ◽

Patients At Risk ◽

Disease Severity Scale

Background:The staging of interstitial lung disease (ILD) is important to monitor disease progression and for prognostication. A disease severity scale of Systemic Sclerosis (SSc)-related lung disease has long been proposed (i.e. Medsger’s severity scale). This scale was mostly developed by discussion and consensus and stage thresholds were not computed by a data-driven approach. Hidden Markov models (HMM) are methods to estimate population quantities for chronic diseases with a staged interpretation which are diagnosed by markers measured at irregular intervals.Objectives:To build a SSc-ILD specific disease severity scale with prognostic relevance via HMM modeling.Methods:A total of 358 SSc patients at risk for or with ILD were enrolled in a discovery (207 cases, Milan1) and in a validation (151 cases, Milan2, Pavia and Rome) cohort. Patients were included if satisfied the following criteria: 1) Diagnosis of SSc according to the EULAR/ACR 2013 criteria, 2) absence of anticentromere antibodies, 3) dcSSc subset or 4) other subsets with either 4a) ILD-related antibodies (Scl70, PmScl, Ku) or 4b) evidence of ILD on HRCT, 5) disease duration < 5 years at the time of the first pulmonary function test (PFT). Serial PFTs were retrieved and the time up to the last available visit -if the patient alive-, or to death due to pulmonary complications, was recorded. HMM were used to estimate the threshold of a 3-stage model (SL3SI, Scleroderma Lung 3-Stage Index) based on PFT functional values (normal/mild, moderate, severe involvement) in the discovery cohort. Survival estimates of the SL3SI model were compared to Medsger’s severity classes estimates and their predictive capability evaluated via the explained residual variation (R2) of prediction errors (the higher the better). One-hundred random replicates were generated to simulate the prediction effort in patients with different disease duration and lung severity.Results:Patients characteristics are summarized in the Table. Fifteen-years survival estimates for Mesdger’s classes in the discovery set were: normal=0.88, mild=0.86, moderate=0.84 and severe=0.71. The SL3SI was defined by the following thresholds: normal/mild, FVC and DLco >=75%; moderate FVC or DLco 74-55%; severe, FVC or DLco <55%. SL3SI 15-yrs survival estimates were: normal/mild=0.89, moderate=0.82 and severe=0.63. Prediction analysis showed a higher R2values at 15 yrs for the SL3SI compared to Medsger’s classes, providing evidence for a better predictive capability of the former (discovery: 0.31 vs 0.25; validation: 0.28 vs 0.19).Conclusion:The SL3SI, a simplified 3-stage functional model of SSc-ILD, yields better survival estimates and long-term prognostic information than Medsger’s classes. Its reproducibility and ease of use make it a useful tool for the functional and prognostic evaluation of SSc patients at risk for or with ILD.Table:VariablesDiscovery (n=207)Replication (n=151)DcSSc62 (30%)98 (64%)Age at first PFR48.6±1249.1±14.4Disease duration at first PFR1.7±1.61.3±2.4FVC90.5±18.191.1±20.2DLco70.7±19.861.3±20.1ILD on HRCT179 (86%)125 (80%)Scl70157 (76%)153 (78%)SSA63 (30%)32 (21%)n of visits38571473Follow-up time, yrs11±5.610.6±5.7Deaths27 (13%)23 (15%)Disclosure of Interests:Alessandro Santaniello: None declared, Chiara Bellocchi: None declared, Luca Bettolini: None declared, Marcello Cassavia: None declared, Gaia Montanelli: None declared, Adriana Severino: None declared, Monica Caronni: None declared, Corrado Campochiaro Speakers bureau: Novartis, Pfizer, Roche, GSK, SOBI, Enrico De Lorenzis: None declared, Gerlando Natalello: None declared, Paolo Delvino: None declared, Claudio Tirelli: None declared, Lorenzo Cavagna: None declared, Giacomo De Luca Speakers bureau: SOBI, Novartis, Celgene, Pfizer, MSD, Silvia Laura Bosello: None declared, Lorenzo Beretta Grant/research support from: Pfizer

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e56 Study of disease severity scale, carotid US features and MRI brain in systemic sclerosis

Rheumatology ◽

10.1093/rheumatology/key075.597 ◽

2018 ◽

Vol 57 (suppl_3) ◽

Author(s):

Rania M Gamal ◽

Hanan S M Abozaid ◽

Mohmed Zidan ◽

Walid M Gamal ◽

Eman Abo Elhamd ◽

...

Keyword(s):

Systemic Sclerosis ◽

Disease Severity ◽

Severity Scale ◽

Mri Brain ◽

Disease Severity Scale

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Predicting Clinical Progression in Multiple Sclerosis With the Magnetic Resonance Disease Severity Scale

Archives of Neurology ◽

10.1001/archneur.65.11.1449 ◽

2008 ◽

Vol 65 (11) ◽

pp. 1449 ◽

Cited By ~ 40

Author(s):

Rohit Bakshi ◽

Mohit Neema ◽

Brian C. Healy ◽

Zsuzsanna Liptak ◽

Rebecca A. Betensky ◽

...

Keyword(s):

Multiple Sclerosis ◽

Magnetic Resonance ◽

Disease Severity ◽

Severity Scale ◽

Clinical Progression ◽

Disease Severity Scale

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Abstract #6: Magnetic Resonance Disease Severity Scale (MRDSS) for Patients with Multiple Sclerosis: A Longitudinal Study

Neurotherapeutics ◽

10.1016/j.nurt.2010.06.008 ◽

2010 ◽

Vol 7 (3) ◽

pp. 329-330

Author(s):

Shahamat S. Tauhid ◽

Jenniffer Moodie ◽

Mohit Neema ◽

Brian C. Healy ◽

Guy J. Buckle ◽

...

Keyword(s):

Multiple Sclerosis ◽

Longitudinal Study ◽

Magnetic Resonance ◽

Disease Severity ◽

Severity Scale ◽

Disease Severity Scale

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Validity and reliability of the hyperhidrosis disease severity scale (HDSS)

Journal of the American Academy of Dermatology ◽

10.1016/j.jaad.2003.10.202 ◽

2004 ◽

Vol 50 (3) ◽

pp. P51 ◽

Cited By ~ 24

Author(s):

Jonathan W. Kowalski ◽

Nina Eadie ◽

Simon Dagget ◽

Pan-Yu Lai

Keyword(s):

Disease Severity ◽

Severity Scale ◽

Validity And Reliability ◽

Disease Severity Scale

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Development and Validation of a Fetal Cardiovascular Disease Severity Scale

Pediatric Cardiology ◽

10.1007/s00246-014-0911-9 ◽

2014 ◽

Vol 35 (7) ◽

pp. 1174-1180 ◽

Cited By ~ 8

Author(s):

Brooke T. Davey ◽

Mary T. Donofrio ◽

Anita J. Moon-Grady ◽

Carlen G. Fifer ◽

Bettina F. Cuneo ◽

...

Keyword(s):

Cardiovascular Disease ◽

Disease Severity ◽

Severity Scale ◽

Disease Severity Scale ◽

Development And Validation

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Metabolic syndrome and adipokine levels in systemic lupus erythematosus and systemic sclerosis

Clinical Rheumatology ◽

10.1007/s10067-021-05731-6 ◽

2021 ◽

Author(s):

Antonietta Gigante ◽

Francesco Iannazzo ◽

Luca Navarini ◽

Maria Chiara Sgariglia ◽

Domenico Paolo Emanuele Margiotta ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Metabolic Syndrome ◽

Systemic Sclerosis ◽

Disease Severity ◽

Lupus Erythematosus ◽

Activity Index ◽

Damage Index ◽

Severity Scale ◽

Systemic Lupus ◽

Disease Severity Scale

Abstract Introduction Aims of study were to evaluate the prevalence of metabolic syndrome (MetS) in systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) patients and to evaluate serum level of adipokines in SLE and SSc patients with and without MetS. Methods Fifty SLE patients and 85 SSc patients were enrolled. The diagnosis of MetS was made according to the criteria of the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. Clinical assessment and serum levels of adiponectin and resistin were evaluate in SLE and SSc patients. Results Prevalence of MetS was significantly (p<0.0001) higher in SLE patients than SSc patients (36% vs 10.6%). Median values of resistin were significantly (p<0.001) higher in SLE patients with MetS than SLE patients without MetS [4.01 ng/mL (2.7–4.5) vs 1.92 ng/mL (1.2–3)]. Median values of adiponectin were significantly (p<0.05) lower in SLE patients with MetS than SLE patients without MetS [5.64 ng/mL (4.96–8) vs 8.38 ng/mL (6.54–11.01)]. Systemic Lupus Erythematosus Activity Index [8 (6–12) vs 10 (6–13), p<0.01] and Systemic Damage Index [2 (1–3) vs 2 (0–3), p<0.001] were significantly higher in MetS patients than in patients without MetS. In SSc, the median value of disease severity scale was significantly higher (p<0.05) in MetS patients than in patients without MetS [7 (5–7) vs 5 (3–6)]. Conclusion Prevalence of MetS is higher in SLE patients. In SLE patients, MetS showed an association with adipokine levels and inflammation/activity disease scores. In SSc patients, MetS was associated with severity of disease. Key Points• Prevalence of metabolic syndrome is higher in SLE patients than SSc patients.• Resistin is higher in SLE patients with metabolic syndrome.• Adineponectin is lower in SLE patients with metabolic syndrome.• Disease severity scale is higher in SSc patients with metabolic syndrome.

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Effects of the peripherally acting μ-opioid receptor antagonist methylnaltrexone on acute pancreatitis severity: study protocol for a multicentre double-blind randomised placebo-controlled interventional trial, the PAMORA-AP trial

Trials ◽

10.1186/s13063-021-05885-3 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Cecilie Siggaard Knoph ◽

Mathias Ellgaard Cook ◽

Camilla Ann Fjelsted ◽

Srdan Novovic ◽

Michael Bau Mortensen ◽

...

Keyword(s):

Acute Pancreatitis ◽

Receptor Antagonist ◽

Disease Severity ◽

Opioid Receptor ◽

Double Blind ◽

Interventional Trial ◽

Opioid Receptor Antagonist ◽

Link Type ◽

Μ Opioid Receptor ◽

Circulating Levels

Abstract Background Moderate to severe acute pancreatitis (AP) is associated with a high rate of complications and increased mortality, yet no targeted pharmacologic treatment currently exists. As pain is a dominant symptom in AP, patients are exposed to excess levels of both endo- and exogenous opioids, which may have harmful effects on the course of AP. This trial investigates the effects of the peripherally acting μ-opioid receptor antagonist (PAMORA) methylnaltrexone on disease severity and clinical outcomes in patients with moderate to severe AP. Methods PAMORA-AP is a multicentre, investigator-initiated, double-blind, randomised, placebo-controlled, interventional trial, which will be conducted at four referral centres for acute pancreatitis in Denmark. Ninety patients with early-onset AP (pain onset within 48 h) as well as predicted moderate to severe disease (two or more systemic inflammatory response syndrome criteria upon admission) will be prospectively included. Subsequently, participants will be randomised (1:1) to intravenous treatment with either methylnaltrexone or matching placebo (Ringer’s lactate) during 5 days of admission. The primary endpoint will be the group difference in disease severity as defined and measured by the Pancreatitis Activity Scoring System (PASS) score 48 h after randomisation. Secondary endpoints include daily PASS scores; disease severity according to the Atlanta classification; quantification of need for analgesics, nutritional support, intravenous fluid resuscitation and antibiotics; duration of hospital admissions, readmission rates and mortality. Pain intensity and gut function will be self-reported using validated questionnaires. Exploratory endpoints include circulating levels of pro-and anti-inflammatory markers, polyethylene glycol recovery from the urine, circulating levels of blood markers of intestinal permeability, the prevalence of pancreatic complications on computed tomography (CT) scans, and colon transit time assessed using a CT-based radiopaque marker method. Discussion This trial aims to evaluate the PAMORA methylnaltrexone as a novel targeted pharmacotherapy in patients with moderate to severe AP with the potential benefit of improved patient outcomes. Trial registration ClinicalTrials.govNCT04743570. Registered on 28 January 2021. EudraCT 2020-002313-18.

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Impacto da hiperidrose primária na qualidade de vida de professores do ensino básico

Research Society and Development ◽

10.33448/rsd-v10i13.21385 ◽

2021 ◽

Vol 10 (13) ◽

pp. e289101321385

Author(s):

Yasmim Anayr Costa Ferrari ◽

Carla Viviane Freitas de Jesus ◽

Edna Santos Dias ◽

Ianka Heloisa Alencar Santos ◽

Thandara Rejane Santos Ferreira Andrade ◽

...

Keyword(s):

Disease Severity ◽

Severity Scale ◽

Disease Severity Scale

Objetivou-se analisar o conhecimento, a prevalência e o impacto da Hiperidrose Primária na qualidade de vida de professores do ensino básico de escolas particulares no município de Aracaju/SE. Pesquisa descritiva, exploratória, com abordagem quantitativa. A coleta de dados foi iniciada com a aplicação de um questionário de conhecimento prévio sobre a Hiperidrose Primária e em seguida foi realizada uma palestra sobre a doença. Após a explanação sobre o tema, os professores responderam outros três questionários, foram eles: Critérios Diagnósticos; Hyperhidrosis Disease Severity Scale; e, Qualidade de Vida – Hiperidrose. Pesquisa aprovada pelo Comitê de Ética em Pesquisa da Universidade Tiradentes (3.266.630). A prevalência de HP foi de 8,2% no estudo, onde 78,3% pertenciam ao sexo feminino, 49,2% na faixa etária de 31 a 40 anos e 61,2% pardos. O início da doença ocorreu entre 15 e 20 anos em 27,3%. Foi identificado o desconhecimento da HP por 82,8% dos professores. Houve predominância do grau 02 em 36,4%. Quanto ao sítio anatômico, 45,5% descreveram o palmar e 45,5% o plantar como principais afetados. O diagnóstico da HP por um profissional de saúde foi relatado por 13,6% dos professores. Sobre a qualidade de vida, verificou-se que a pontuação total dos domínios variou de 20 (excelente) a 75 (ruim), com média de 46,7 pontos, onde 3 (13,6%) foram classificados como ruim. Dessa forma, atuar na divulgação de informações sobre a HP é essencial para ampliar os conhecimentos sobre essa doença entre profissionais, alunos, pais e responsáveis.

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