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1.
Br J Community Nurs ; 26(10): 482-492, 2021 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-34632789

RESUMO

The provision of acute healthcare within patients own home (i.e. hospital in the home) is an important method of providing individualised patient-centred care that reduces the need for acute hospital admissions and enables early hospital discharge for appropriate patient groups. The Hospital in the Home (HitH) model of care ensures that this approach maximises patient safety and limits potential risk for patients. As HitH services have seen record numbers of patient referrals in the past 2 years, there is now a greater need to measure and understand the acuity and dependency levels of the caseload. Through an expert clinician development process at one NHS trust, aspects of procedural complexity, interdisciplinary working, risk stratification and comorbidities were used to quantify acuity and dependency. This paper uses a case study approach to present a new method of measuring this important concept.


Assuntos
Atenção à Saúde/métodos , Gravidade do Paciente , Segurança do Paciente , Encaminhamento e Consulta , Doença Aguda/terapia , Serviços de Assistência Domiciliar , Hospitalização , Humanos
4.
PLoS Pathog ; 17(9): e1009804, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34529726

RESUMO

Prior studies have demonstrated that immunologic dysfunction underpins severe illness in COVID-19 patients, but have lacked an in-depth analysis of the immunologic drivers of death in the most critically ill patients. We performed immunophenotyping of viral antigen-specific and unconventional T cell responses, neutralizing antibodies, and serum proteins in critically ill patients with SARS-CoV-2 infection, using influenza infection, SARS-CoV-2-convalescent health care workers, and healthy adults as controls. We identify mucosal-associated invariant T (MAIT) cell activation as an independent and significant predictor of death in COVID-19 (HR = 5.92, 95% CI = 2.49-14.1). MAIT cell activation correlates with several other mortality-associated immunologic measures including broad activation of CD8+ T cells and non-Vδ2 γδT cells, and elevated levels of cytokines and chemokines, including GM-CSF, CXCL10, CCL2, and IL-6. MAIT cell activation is also a predictor of disease severity in influenza (ECMO/death HR = 4.43, 95% CI = 1.08-18.2). Single-cell RNA-sequencing reveals a shift from focused IFNα-driven signals in COVID-19 ICU patients who survive to broad pro-inflammatory responses in fatal COVID-19 -a feature not observed in severe influenza. We conclude that fatal COVID-19 infection is driven by uncoordinated inflammatory responses that drive a hierarchy of T cell activation, elements of which can serve as prognostic indicators and potential targets for immune intervention.


Assuntos
COVID-19/imunologia , COVID-19/mortalidade , Anticorpos Neutralizantes/imunologia , Anticorpos Antivirais/imunologia , Antígenos CD/imunologia , Antígenos de Diferenciação de Linfócitos T/imunologia , Linfócitos B/imunologia , Biomarcadores/sangue , Proteínas Sanguíneas/metabolismo , Estudos de Coortes , Estado Terminal/mortalidade , Feminino , Humanos , Imunofenotipagem , Influenza Humana/imunologia , Lectinas Tipo C/imunologia , Ativação Linfocitária , Masculino , Pessoa de Meia-Idade , Células T Invariantes Associadas à Mucosa/imunologia , Gravidade do Paciente
5.
N Engl J Med ; 385(15): 1393-1400, 2021 10 07.
Artigo em Inglês | MEDLINE | ID: mdl-34525275

RESUMO

BACKGROUND: On July 30, 2021, the administration of a third (booster) dose of the BNT162b2 messenger RNA vaccine (Pfizer-BioNTech) was approved in Israel for persons who were 60 years of age or older and who had received a second dose of vaccine at least 5 months earlier. Data are needed regarding the effect of the booster dose on the rate of confirmed coronavirus 2019 disease (Covid-19) and the rate of severe illness. METHODS: We extracted data for the period from July 30 through August 31, 2021, from the Israeli Ministry of Health database regarding 1,137,804 persons who were 60 years of age or older and had been fully vaccinated (i.e., had received two doses of BNT162b2) at least 5 months earlier. In the primary analysis, we compared the rate of confirmed Covid-19 and the rate of severe illness between those who had received a booster injection at least 12 days earlier (booster group) and those who had not received a booster injection (nonbooster group). In a secondary analysis, we evaluated the rate of infection 4 to 6 days after the booster dose as compared with the rate at least 12 days after the booster. In all the analyses, we used Poisson regression after adjusting for possible confounding factors. RESULTS: At least 12 days after the booster dose, the rate of confirmed infection was lower in the booster group than in the nonbooster group by a factor of 11.3 (95% confidence interval [CI], 10.4 to 12.3); the rate of severe illness was lower by a factor of 19.5 (95% CI, 12.9 to 29.5). In a secondary analysis, the rate of confirmed infection at least 12 days after vaccination was lower than the rate after 4 to 6 days by a factor of 5.4 (95% CI, 4.8 to 6.1). CONCLUSIONS: In this study involving participants who were 60 years of age or older and had received two doses of the BNT162b2 vaccine at least 5 months earlier, we found that the rates of confirmed Covid-19 and severe illness were substantially lower among those who received a booster (third) dose of the BNT162b2 vaccine.


Assuntos
Vacinas contra COVID-19 , COVID-19/prevenção & controle , Imunização Secundária , Idoso , Idoso de 80 Anos ou mais , COVID-19/epidemiologia , Bases de Dados Factuais , Feminino , Humanos , Israel/epidemiologia , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente , Distribuição de Poisson , SARS-CoV-2
6.
Am J Emerg Med ; 46: 410-415, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34348436

RESUMO

BACKGROUND AND IMPORTANCE: Emergency department (ED) admissions have been rising over the last decades, especially in countries without any effective gate-keeping functions. Integration of walk-in clinics into the hospital might reduce ED-visits. Over a longer period, however, the additional service of a walk-in clinic might attract even more patients, nullifying an initial decrease in patients for the ED. OBJECTIVES, DESIGN, SETTINGS AND PARTICIPANTS: This study aimed to determine short- and intermediate-term changes after the implementation of a hospital-integrated walk-in clinic. This is an observational study using routinely-collected health data. Study setting was the ED of a large tertiary care hospital in Austria, a country with universal health care and no regulations regarding level of care. OUTCOMES MEASURE AND ANALYSIS: ED-visits were compared between before (2015) and after (2017 and 2018) establishment of a hospital-integrated walk-in clinic. MAIN RESULTS: Total ED-visits decreased from 87,624 in 2015 to 67,479 in 2017, and 67,871 in 2018 (p < 0.001), mainly due to a decrease in non-urgent (ESI 4 & 5) cases (45,715 (54.1%) in 2015; 33,142 (51.3%) in 2017; 30,846 (47.5%) in 2018; short term OR non-urgent vs. urgent: 0.89 (95% CI 0.88-0.91); intermediate term OR urgent vs. non-urgent: 0.76 (95% CI 0.78-0.75)). A total of 2611 (13%) (2017) and 1714 (8.5%) (2018) patients were referred back to the ED. CONCLUSIONS: After the introduction of the walk-in clinic, ED-visits declined significantly. This remained stable over a two-year period. Reduction in ED-visits was mainly due to low-acuity patients not requiring admission to the hospital.


Assuntos
Grupos Diagnósticos Relacionados , Serviço Hospitalar de Emergência/estatística & dados numéricos , Ambulatório Hospitalar , Adulto , Áustria , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente
8.
BMC Pulm Med ; 21(1): 275, 2021 Aug 23.
Artigo em Inglês | MEDLINE | ID: mdl-34425811

RESUMO

BACKGROUND: How cigarette smoke (CS) and chronic obstructive pulmonary disease (COPD) affect severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection and severity is controversial. We investigated the effects of COPD and CS on the expression of SARS-CoV-2 entry receptor ACE2 in vivo in COPD patients and controls and in CS-exposed mice, and the effects of CS on SARS-CoV-2 infection in human bronchial epithelial cells in vitro. METHODS: We quantified: (1) pulmonary ACE2 protein levels by immunostaining and ELISA, and both ACE2 and/or TMPRSS2 mRNA levels by RT-qPCR in two independent human cohorts; and (2) pulmonary ACE2 protein levels by immunostaining and ELISA in C57BL/6 WT mice exposed to air or CS for up to 6 months. The effects of CS exposure on SARS-CoV-2 infection were evaluated after in vitro infection of Calu-3 cells and differentiated human bronchial epithelial cells (HBECs), respectively. RESULTS: ACE2 protein and mRNA levels were decreased in peripheral airways from COPD patients versus controls but similar in central airways. Mice exposed to CS had decreased ACE2 protein levels in their bronchial and alveolar epithelia versus air-exposed mice. CS treatment decreased viral replication in Calu-3 cells, as determined by immunofluorescence staining for replicative double-stranded RNA (dsRNA) and western blot for viral N protein. Acute CS exposure decreased in vitro SARS-CoV-2 replication in HBECs, as determined by plaque assay and RT-qPCR. CONCLUSIONS: ACE2 levels were decreased in both bronchial and alveolar epithelial cells from COPD patients versus controls, and from CS-exposed versus air-exposed mice. CS-pre-exposure potently inhibited SARS-CoV-2 replication in vitro. These findings urge to investigate further the controversial effects of CS and COPD on SARS-CoV-2 infection.


Assuntos
Enzima de Conversão de Angiotensina 2/metabolismo , COVID-19/enzimologia , Fumar Cigarros/metabolismo , Doença Pulmonar Obstrutiva Crônica/enzimologia , SARS-CoV-2/fisiologia , Fumaça , Idoso , Idoso de 80 Anos ou mais , Enzima de Conversão de Angiotensina 2/genética , Animais , Brônquios , Linhagem Celular Tumoral , Feminino , Humanos , Masculino , Camundongos , Pessoa de Meia-Idade , Gravidade do Paciente , Alvéolos Pulmonares , RNA Mensageiro/metabolismo , Mucosa Respiratória/metabolismo , Serina Endopeptidases/genética , Tabaco , Replicação Viral
9.
Sci Rep ; 11(1): 16290, 2021 08 11.
Artigo em Inglês | MEDLINE | ID: mdl-34381066

RESUMO

To reveal if coagulopathies relate to the course of COVID-19, we examined 255 patients with moderate and severe COVID-19, receiving anticoagulants and immunosuppressive drugs. Coagulopathy manifested predominantly as hypercoagulability that correlated directly with systemic inflammation, disease severity, comorbidities, and mortality risk. The prolonged clotting tests in about » of cases were associated with high levels of C-reactive protein and antiphospholipid antibodies, which impeded coagulation in vitro. Contraction of blood clots was hindered in about ½ of patients, especially in severe and fatal cases, and correlated directly with prothrombotic parameters. A decrease in platelet contractility was due to moderate thrombocytopenia in combination with platelet dysfunction. Clots with impaired contraction were porous, had a low content of compressed polyhedral erythrocytes (polyhedrocytes) and an even distribution of fibrin, suggesting that the uncompacted intravital clots are more obstructive but patients could also be prone to bleeding. The absence of consumption coagulopathy suggests the predominance of local and/or regional microthrombosis rather than disseminated intravascular coagulation. The results obtained (i) confirm the importance of hemostatic disorders in COVID-19 and their relation to systemic inflammation; (ii) justify monitoring of hemostasis, including the kinetics of blood clot contraction; (iii) substantiate the active prophylaxis of thrombotic complications in COVID-19.


Assuntos
Transtornos da Coagulação Sanguínea/etiologia , Transtornos Plaquetários/etiologia , COVID-19/complicações , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Transtornos da Coagulação Sanguínea/tratamento farmacológico , Plaquetas/ultraestrutura , COVID-19/tratamento farmacológico , Feminino , Humanos , Inflamação/etiologia , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente , Trombocitopenia/etiologia , Resultado do Tratamento , Adulto Jovem
10.
Sci Rep ; 11(1): 16361, 2021 08 11.
Artigo em Inglês | MEDLINE | ID: mdl-34381155

RESUMO

Evidence on the efficacy of adding macrolides (azithromycin or clarithromycin) to the treatment regimen for COVID-19 is limited. We testify whether adding azithromycin or clarithromycin to a standard of care regimen was superior to standard of supportive care alone in patients with mild COVID-19.This randomized trial included three groups of patients with COVID-19. The azithromycin group included, 107 patients who received azithromycin 500 mg/24 h for 7 days, the clarithromycin group included 99 patients who received clarithromycin 500 /12 h for 7 days, and the control group included 99 patients who received standard care only. All three groups received only symptomatic treatment for control of fever and cough .Clinical and biochemical evaluations of the study participants including assessment of the symptoms duration, real-time reverse transcription-polymerase chain reaction (rRT-PCR), C-reactive protein (CRP), serum ferritin, D-dimer, complete blood count (CBC), in addition to non-contrast chest computed tomography (CT), were performed. The overall results revealed significant early improvement of symptoms (fever, dyspnea and cough) in patients treated with either azithromycin or clarithromycin compared to control group, also there was significant early conversion of SARS-CoV-2 PCR to negative in patients treated with either azithromycin or clarithromycin compared to control group (p < 0.05 for all).There was no significant difference in time to improvement of fever, cough, dyspnea, anosmia, gastrointestinal tract "GIT" symptoms and time to PCR negative conversion between patients treated with azithromycin compared to patients treated with clarithromycin (p > 0.05 for all). Follow up chest CT done after 2 weeks of start of treatment showed significant improvement in patients treated with either azithromycin or clarithromycin compared to control group (p < 0.05 for all).Adding Clarithromycin or azithromycin to the therapeutic protocols for COVID-19 could be beneficial for early control of fever and early PCR negative conversion in Mild COVID-19.Trial registration: (NCT04622891) www.ClinicalTrials.gov retrospectively registered (November 10, 2020).


Assuntos
Azitromicina/uso terapêutico , COVID-19/tratamento farmacológico , Claritromicina/uso terapêutico , Adulto , COVID-19/fisiopatologia , Feminino , Febre/tratamento farmacológico , Febre/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente , Resultado do Tratamento
12.
Front Immunol ; 12: 720090, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34434199

RESUMO

Male sex and old age are risk factors for COVID-19 severity, but the underlying causes are unknown. A possible explanation for this might be the differences in immunological profiles in males and the elderly before the infection. With this in mind, we analyzed the abundance of circulating proteins and immune populations associated with severe COVID-19 in 2 healthy cohorts. Besides, given the seasonal profile of COVID-19, the seasonal response against SARS-CoV-2 could also be different in the elderly and males. Therefore, PBMCs of female, male, young, and old subjects in different seasons of the year were stimulated with heat-inactivated SARS-CoV-2 to investigate the season-dependent anti-SARS-CoV-2 immune response. We found that several T cell subsets, which are known to be depleted in severe COVID-19 patients, were intrinsically less abundant in men and older individuals. Plasma proteins increasing with disease severity, including HGF, IL-8, and MCP-1, were more abundant in the elderly and males. Upon in vitro SARS-CoV-2 stimulation, the elderly produced significantly more IL-1RA and had a dysregulated IFNγ response with lower production in the fall compared with young individuals. Our results suggest that the immune characteristics of severe COVID-19, described by a differential abundance of immune cells and circulating inflammatory proteins, are intrinsically present in healthy men and the elderly. This might explain the susceptibility of men and the elderly to SARS-CoV-2 infection.


Assuntos
COVID-19/imunologia , Adolescente , Adulto , Fatores Etários , Idoso , Envelhecimento/imunologia , Proteínas Sanguíneas/imunologia , COVID-19/fisiopatologia , Estudos de Coortes , Suscetibilidade a Doenças , Feminino , Humanos , Imunidade Celular , Fatores Imunológicos , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente , Medição de Risco , Estações do Ano , Fatores Sexuais , Subpopulações de Linfócitos T/imunologia , Adulto Jovem
13.
Sci Immunol ; 6(59)2021 05 13.
Artigo em Inglês | MEDLINE | ID: mdl-34446527

RESUMO

Complement activation has been implicated in the pathogenesis of severe SARS-CoV-2 infection. However, it remains to be determined whether increased complement activation is a broad indicator of critical illness (and thus, no different in COVID-19). It is also unclear which pathways are contributing to complement activation in COVID-19, and if complement activation is associated with certain features of severe SARS-CoV-2 infection, such as endothelial injury and hypercoagulability. To address these questions, we investigated complement activation in the plasma from patients with COVID-19 prospectively enrolled at two tertiary care centers: Washington University School of Medicine (n=134) and Yale School of Medicine (n=49). We compared our patients to two non-COVID cohorts: (a) patients hospitalized with influenza (n=54), and (b) patients admitted to the intensive care unit (ICU) with acute respiratory failure requiring invasive mechanical ventilation (IMV, n=22). We demonstrate that circulating markers of complement activation are elevated in patients with COVID-19 compared to those with influenza and to patients with non-COVID-19 respiratory failure. Further, the results facilitate distinguishing those who are at higher risk of worse outcomes such as requiring ICU admission, or IMV. Moreover, the results indicate enhanced activation of the alternative complement pathway is most prevalent in patients with severe COVID-19 and is associated with markers of endothelial injury (i.e., angiopoietin-2) as well as hypercoagulability (i.e., thrombomodulin and von Willebrand factor). Our findings identify complement activation to be a distinctive feature of COVID-19, and provide specific targets that may be utilized for risk prognostication, drug discovery and personalized clinical trials.


Assuntos
COVID-19/imunologia , Ativação do Complemento , Idoso , Biomarcadores/sangue , COVID-19/complicações , COVID-19/patologia , Estudos de Coortes , Estado Terminal , Endotélio Vascular/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente , Estudos Prospectivos , Trombose/patologia , Trombose/virologia , Resultado do Tratamento
14.
Front Immunol ; 12: 720192, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34456928

RESUMO

COVID-19 might lead to multi-organ failure and, in some cases, to death. The COVID-19 severity is associated with a "cytokine storm." Danger-associated molecular patterns (DAMPs) are proinflammatory molecules that can activate pattern recognition receptors, such as toll-like receptors (TLRs). DAMPs and TLRs have not received much attention in COVID-19 but can explain some of the gender-, weight- and age-dependent effects. In females and males, TLRs are differentially expressed, likely contributing to higher COVID-19 severity in males. DAMPs and cytokines associated with COVID-19 mortality are elevated in obese and elderly individuals, which might explain the higher risk for severer COVID-19 in these groups. Adenosine signaling inhibits the TLR/NF-κB pathway and, through this, decreases inflammation and DAMPs' effects. As vaccines will not be effective in all susceptible individuals and as new vaccine-resistant SARS-CoV-2 mutants might develop, it remains mandatory to find means to dampen COVID-19 disease severity, especially in high-risk groups. We propose that the regulation of DAMPs via adenosine signaling enhancement might be an effective way to lower the severity of COVID-19 and prevent multiple organ failure in the absence of severe side effects.


Assuntos
Alarminas/imunologia , COVID-19/fisiopatologia , Mediadores da Inflamação/imunologia , Adenosina/metabolismo , Alarminas/antagonistas & inibidores , Animais , COVID-19/complicações , COVID-19/imunologia , COVID-19/terapia , Humanos , Inflamação/prevenção & controle , Mediadores da Inflamação/antagonistas & inibidores , Insuficiência de Múltiplos Órgãos/etiologia , Insuficiência de Múltiplos Órgãos/prevenção & controle , Gravidade do Paciente , Transdução de Sinais , Receptores Toll-Like/antagonistas & inibidores , Receptores Toll-Like/imunologia
16.
Front Immunol ; 12: 679841, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34421894

RESUMO

Understanding the course of the antibody response directed to individual epitopes of SARS-CoV-2 proteins is crucial for serological assays and establishment of vaccines. Twenty-one synthetic peptides were synthesized that have ten amino acids overlap and cover the complete membrane (M) protein. Plasma samples from 32 patients having acute disease and 30 patients from the convalescent phase were studied. Only peptide M01 (aa 1-20) and to a lesser extent peptide M21 (aa 201-222) showed specific reactivity as compared to historical control plasma samples. Peptide M01 was recognized by IgM- (71.9%) and IgG-specific antibodies (43.8%) during the acute phase as early as day 8 PIO. In a longitudinal analysis, a higher reactivity was observed for the IgM response directed to peptide M01 following day 20 PIO as compared to earlier time points of the acute phase. In the convalescent phase, antibody reactivity to the two M-specific peptides was significantly lower (<30% seropositivity). A fusion protein encoding major parts of RBD also showed higher rates of recognition during acute (50.0%) and lower rates in the convalescent phase (23.3%). Taken together, our results suggest that during the acute phase of COVID-19 antibodies are raised to two linear epitopes of the SARS-CoV-2 M protein, located at the very N- and C-termini, showing almost similar levels of reactivity as immunodominant linear epitopes derived from the spike and nucleocapsid protein. Anti-M is also present in the convalescent phase of COVID-19 patients, however at lower levels, with the N-terminus of the M protein as a preferred target.


Assuntos
Anticorpos Antivirais/imunologia , COVID-19/imunologia , SARS-CoV-2/imunologia , Proteínas da Matriz Viral/imunologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Antivirais/biossíntese , Convalescença , Proteínas do Nucleocapsídeo de Coronavírus/imunologia , Feminino , Humanos , Epitopos Imunodominantes/imunologia , Imunoglobulina M/imunologia , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente , Fragmentos de Peptídeos/imunologia , Proteínas Recombinantes de Fusão/imunologia , SARS-CoV-2/genética , Glicoproteína da Espícula de Coronavírus/imunologia , Proteínas da Matriz Viral/genética
17.
N Engl J Med ; 385(9): 774-775, 2021 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-34415688
18.
N Engl J Med ; 385(13): 1184-1195, 2021 09 23.
Artigo em Inglês | MEDLINE | ID: mdl-34347950

RESUMO

BACKGROUND: REGEN-COV (previously known as REGN-COV2), a combination of the monoclonal antibodies casirivimab and imdevimab, has been shown to markedly reduce the risk of hospitalization or death among high-risk persons with coronavirus disease 2019 (Covid-19). Whether subcutaneous REGEN-COV prevents severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and subsequent Covid-19 in persons at high risk for infection because of household exposure to a person with SARS-CoV-2 infection is unknown. METHODS: We randomly assigned, in a 1:1 ratio, participants (≥12 years of age) who were enrolled within 96 hours after a household contact received a diagnosis of SARS-CoV-2 infection to receive a total dose of 1200 mg of REGEN-COV or matching placebo administered by means of subcutaneous injection. At the time of randomization, participants were stratified according to the results of the local diagnostic assay for SARS-CoV-2 and according to age. The primary efficacy end point was the development of symptomatic SARS-CoV-2 infection through day 28 in participants who did not have SARS-CoV-2 infection (as measured by reverse-transcriptase-quantitative polymerase-chain-reaction assay) or previous immunity (seronegativity). RESULTS: Symptomatic SARS-CoV-2 infection developed in 11 of 753 participants in the REGEN-COV group (1.5%) and in 59 of 752 participants in the placebo group (7.8%) (relative risk reduction [1 minus the relative risk], 81.4%; P<0.001). In weeks 2 to 4, a total of 2 of 753 participants in the REGEN-COV group (0.3%) and 27 of 752 participants in the placebo group (3.6%) had symptomatic SARS-CoV-2 infection (relative risk reduction, 92.6%). REGEN-COV also prevented symptomatic and asymptomatic infections overall (relative risk reduction, 66.4%). Among symptomatic infected participants, the median time to resolution of symptoms was 2 weeks shorter with REGEN-COV than with placebo (1.2 weeks and 3.2 weeks, respectively), and the duration of a high viral load (>104 copies per milliliter) was shorter (0.4 weeks and 1.3 weeks, respectively). No dose-limiting toxic effects of REGEN-COV were noted. CONCLUSIONS: Subcutaneous REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load. (Funded by Regeneron Pharmaceuticals and others; ClinicalTrials.gov number, NCT04452318.).


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , COVID-19/prevenção & controle , SARS-CoV-2 , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Doenças Assintomáticas , COVID-19/tratamento farmacológico , COVID-19/virologia , Criança , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Humanos , Incidência , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente , Carga Viral , Adulto Jovem
19.
N Engl J Med ; 385(10): 875-884, 2021 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-34233097

RESUMO

BACKGROUND: Mass vaccination campaigns to prevent coronavirus disease 2019 (Covid-19) are occurring in many countries; estimates of vaccine effectiveness are urgently needed to support decision making. A countrywide mass vaccination campaign with the use of an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (CoronaVac) was conducted in Chile starting on February 2, 2021. METHODS: We used a prospective national cohort, including participants 16 years of age or older who were affiliated with the public national health care system, to assess the effectiveness of the inactivated SARS-CoV-2 vaccine with regard to preventing Covid-19 and related hospitalization, admission to the intensive care unit (ICU), and death. We estimated hazard ratios using the extension of the Cox proportional-hazards model, accounting for time-varying vaccination status. We estimated the change in the hazard ratio associated with partial immunization (≥14 days after receipt of the first dose and before receipt of the second dose) and full immunization (≥14 days after receipt of the second dose). Vaccine effectiveness was estimated with adjustment for individual demographic and clinical characteristics. RESULTS: The study was conducted from February 2 through May 1, 2021, and the cohort included approximately 10.2 million persons. Among persons who were fully immunized, the adjusted vaccine effectiveness was 65.9% (95% confidence interval [CI], 65.2 to 66.6) for the prevention of Covid-19 and 87.5% (95% CI, 86.7 to 88.2) for the prevention of hospitalization, 90.3% (95% CI, 89.1 to 91.4) for the prevention of ICU admission, and 86.3% (95% CI, 84.5 to 87.9) for the prevention of Covid-19-related death. CONCLUSIONS: Our results suggest that the inactivated SARS-CoV-2 vaccine effectively prevented Covid-19, including severe disease and death, a finding that is consistent with results of phase 2 trials of the vaccine. (Funded by Agencia Nacional de Investigación y Desarrollo and others.).


Assuntos
Vacinas contra COVID-19/imunologia , COVID-19/prevenção & controle , Imunogenicidade da Vacina , Vacinação em Massa , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19/epidemiologia , COVID-19/mortalidade , Chile/epidemiologia , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente , Estudos Prospectivos , Resultado do Tratamento , Vacinas de Produtos Inativados , Adulto Jovem
20.
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