Assuntos
COVID-19/terapia , Pandemias , SARS-CoV-2 , Anticorpos Antivirais/imunologia , Anticorpos Antivirais/uso terapêutico , Segurança do Sangue , Infecções Transmitidas por Sangue/prevenção & controle , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/provisão & distribuição , Países em Desenvolvimento , Previsões , Humanos , Imunização Passiva/ética , Imunização Passiva/normas , Cooperação Internacional , Controle de Qualidade , SARS-CoV-2/genética , SARS-CoV-2/imunologia , Resultado do Tratamento , Soroterapia para COVID-19RESUMO
We summarize here in vitro evidences of efficacy for convalescent plasma, currently approved vaccines and monoclonal antibodies against SARS-CoV-2 variants of concern (VOC: B.1.1.7, B.1.351, P.1, and B.1.617.2), variants of interest (VOI: B.1.427/B.1.429, P.2, B.1.525, P.3, B.1.526, and B.1.671.1), and other strains (B.1.1.298 and B.1.258delta). While waiting from real world clinical efficacy, these data provide guidance for the treating physician.
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Anticorpos Monoclonais/imunologia , Anticorpos Antivirais/sangue , Plasma/imunologia , SARS-CoV-2/imunologia , Vacinas Virais/imunologia , Anticorpos Monoclonais Humanizados/imunologia , Anticorpos Neutralizantes/imunologia , COVID-19/terapia , Humanos , Imunização Passiva/normas , Técnicas In Vitro , Testes de Neutralização , Glicoproteína da Espícula de Coronavírus/imunologia , Soroterapia para COVID-19RESUMO
The treatment of COVID-19 is particularly critical in pregnant women, considering the potential teratogenic effects of antiviral agents and the immune-depression related with pregnancy. The aim of this review is to systematically examine the current evidence on the clinical use of convalescent plasma during pregnancy. The electronic databases Medline PubMed Advanced Search Builder, Scopus, Web Of Science and Google Scholar were searched (until 1 January 2021). Inclusion criteria were pregnant women with COVID-19 (or SARS-CoV-2 infection), in whom convalescent plasma (or hyperimmune plasma) was used as treatment. We searched clinical trial registries (censored 5 January 2021) for eligible studies under way. After elimination of duplications, the initial search yielded 79 potentially relevant records, of which 67 were subsequently excluded. The 12 remaining records were case reports involving 12 pregnancies. Six of the mothers were reported to be well, two were reported to have preeclampsia, and in one case each the maternal outcome was described as survival, clinical improvement, discharged with oxygen and rehabilitation. With regard to the neonates, two were declared to be well, four had transient morbidity, two were critically ill and one died; normal ongoing pregnancies, but no post-delivery information, were reported for the remaining three cases. Clinical trials under way or planned to investigate the use of convalescent plasma for COVID-19 during pregnancy are lacking. This is the first systematic review of the literature regarding the treatment of COVID-19 in pregnancy. The published literature data seem to indicate that convalescent plasma administered to pregnant women with severe COVID-19 provides benefits for both the mother and the fetus. The quality of the available studies is, however, very limited since they are all case reports and thus suffer from relevant reporting bias.
Assuntos
Antivirais/uso terapêutico , COVID-19/terapia , Complicações Infecciosas na Gravidez/terapia , Adulto , COVID-19/imunologia , Estado Terminal , Bases de Dados Factuais , Feminino , Humanos , Imunização Passiva/métodos , Imunização Passiva/normas , Recém-Nascido , Gravidez , Gestantes , Resultado do Tratamento , Soroterapia para COVID-19RESUMO
BACKGROUND: Therapies against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and its life-threatening respiratory infection coronavirus disease 2019 (COVID-19) have been evaluated, including COVID-19 convalescent plasma (CCP). Multiple large reports of CCP treatment in adults exist. Pediatric data on CCP safety and efficacy are limited. METHODS: Single-center prospective, open-label trial looking at safety, antibody kinetics and outcomes of CCP (10 mL/kg, max 1 unit) treatment for COVID-19 in hospitalized pediatric patients with moderate to severe disease or at high-risk for serious illness. RESULTS: Thirteen patients were enrolled. No infusion-related adverse events occurred. No hematologic or metabolic adverse events were noted during hospitalization or at 3-weeks. Ten patients had clinical improvement by day 7 (WHO eight-category ordinal severity scale for COVID-19). Following CCP, anti-SARS-CoV-2 anti-nucleocapsid IgG increased significantly at 24 hours and high levels were sustained at 7- and 21-days. Transient IgM response was noted. Twelve patients (92.3%) were discharged home, 9 (75%) by day 7 post-CCP. One remained on invasive ventilatory support 42 days after CCP and was eventually discharged to an intermediate care facility. The single patient death was retrospectively confirmed to have had brain death before CCP. CONCLUSION: CCP was well tolerated in pediatric patients, resulted in rapid antibody increase, and did not appear to interfere with immune responses measured at 21 days. More pediatric data are necessary to establish the efficacy of CCP, but our data suggest benefit in moderate to severe COVID-19 when used early. Other immunologic or antiviral interventions may be added as supported by emerging data.
Assuntos
COVID-19/terapia , Adolescente , Anticorpos Antivirais/sangue , Criança , Pré-Escolar , Feminino , Humanos , Imunização Passiva/normas , Imunização Passiva/estatística & dados numéricos , Imunoglobulina G/sangue , Lactente , Recém-Nascido , Cinética , Masculino , Estudos Prospectivos , Estudos Retrospectivos , Soroterapia para COVID-19RESUMO
Clinical management protocols for COVID-19 are evolving rapidly as more information about the epidemiology and pathophysiological changes in COVID-19 become available. However, no definite treatment of COVID-19 has been found till date. The COVID-19 convalescent plasma (CCP) therapy has emerged as an important investigational therapy in the management of COVID-19 patients. Additionally, the regulatory agencies, in particular, the Indian blood transfusion council must release some interim recommendations for the blood centres on the CCP blood donor eligibility criteria after COVID-19 vaccination. More clinical trials are needed to know the efficacy of the CCP harvested from COVID-19 recovered individuals who have been vaccinated against those COVID-19 recovered individuals who are not vaccinated to understand the vaccine impact on the IgG titres of anti-SARS-CoV-2 antibodies.
Assuntos
Anticorpos Antivirais/uso terapêutico , Segurança do Sangue , Vacinas contra COVID-19 , COVID-19/terapia , Seleção do Doador/normas , Imunoglobulina G/uso terapêutico , Pandemias , SARS-CoV-2/imunologia , Anticorpos Antivirais/sangue , Anticorpos Antivirais/imunologia , COVID-19/sangue , COVID-19/imunologia , Experimentação Humana , Humanos , Imunização Passiva/ética , Imunização Passiva/normas , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Consentimento Livre e Esclarecido , Proteínas Virais/imunologia , Soroterapia para COVID-19RESUMO
The worldwide spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the associated infectious coronavirus disease (COVID-19) has posed a unique challenge to medical staff, patients and their families. Patients with cancer, particularly those with haematologic malignancies, have been identified to be at high risk to develop severe COVID-19. Since publication of our previous guideline on evidence-based management of COVID-19 in patients with cancer, research efforts have continued and new relevant data has come to light, maybe most importantly in the field of vaccination studies. Therefore, an update of our guideline on several clinically important topics is warranted. Here, we provide a concise update of evidence-based recommendations for rapid diagnostics, viral shedding, vaccination and therapy of COVID-19 in patients with cancer. This guideline update was prepared by the Infectious Diseases Working Party (AGIHO) of the German Society for Haematology and Medical Oncology by critically reviewing the currently available data on these topics applying evidence-based medicine criteria.
Assuntos
Teste para COVID-19/normas , Vacinas contra COVID-19/uso terapêutico , COVID-19 , Neoplasias , SARS-CoV-2/fisiologia , Eliminação de Partículas Virais/fisiologia , Antivirais/uso terapêutico , COVID-19/diagnóstico , COVID-19/epidemiologia , COVID-19/terapia , COVID-19/virologia , Teste para COVID-19/métodos , Medicina Baseada em Evidências/normas , Medicina Baseada em Evidências/estatística & dados numéricos , Alemanha/epidemiologia , Neoplasias Hematológicas/diagnóstico , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/terapia , Neoplasias Hematológicas/virologia , Hematologia/organização & administração , Hematologia/normas , Humanos , Imunização Passiva/métodos , Imunização Passiva/normas , Infectologia/organização & administração , Infectologia/normas , Oncologia/organização & administração , Oncologia/normas , Neoplasias/diagnóstico , Neoplasias/epidemiologia , Neoplasias/terapia , Neoplasias/virologia , SARS-CoV-2/imunologia , Sociedades Médicas/normas , Vacinação/métodos , Vacinação/normas , Soroterapia para COVID-19RESUMO
TITLE: Faire du commun dans les sciences - Conflictualités et pluralisme à l'épreuve des essais cliniques COVID-19. ABSTRACT: La crise de la COVID-19 s'est ouverte sur un déficit de moyens thérapeutiques permettant de lutter efficacement contre cette maladie pour les cas les plus graves et sur de nombreuses initiatives visant à mettre en évidence un traitement efficace. Si différentes options ont été explorées, parmi lesquelles la transfusion de plasma de patients guéris, la lutte contre les mécanismes immunitaires déclenchant une réponse trop forte (les orages cytokiniques) ou, à moyen terme, la vaccination, ce sont dans un premier temps surtout les médicaments antiviraux qui ont nourri les espoirs. Après l'identification d'un certain nombre de principes actifs montrant des effets in vitro, il s'agissait d'obtenir rapidement des réponses quant à leurs effets bénéfiques in vivo et aux risques induits. Aussi, s'est-on senti en droit d'attendre que la science nous apporte les connaissances nécessaires sur ces médicaments, qu'elle nous parle, une fois sollicitée, de manière claire et d'une seule voix ; et cela, dans une situation d'urgence où la synchronisation des rythmes de la recherche et du soin n'a rien d'une évidence.
Assuntos
COVID-19/terapia , Protocolos Clínicos/normas , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Diversidade Cultural , Antivirais/isolamento & purificação , Antivirais/provisão & distribuição , Antivirais/uso terapêutico , Viés , COVID-19/epidemiologia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Redes Comunitárias/normas , História do Século XXI , Humanos , Imunização Passiva/métodos , Imunização Passiva/normas , Pandemias , Padrões de Referência , SARS-CoV-2/fisiologia , Soroterapia para COVID-19RESUMO
Convalescent plasma has emerged as a treatment that merits consideration for COVID-19-positive patients requiring hospitalization. With millions of cases of COVID-19 being reported worldwide, nurses across specialties are caring for infected patients and are often the primary patient educators about convalescent plasma treatment. Keeping abreast of current clinical guidelines and evidence-based practice allows nurses to identify patients who should be considered for treatment, understand the administration guidelines, and be aware of the toxicity profile to provide safe and high-quality care to patients. The purpose of this article is to provide information on convalescent plasma as a treatment for COVID-19.
Assuntos
Anticorpos Antivirais/administração & dosagem , Anticorpos Antivirais/uso terapêutico , COVID-19/imunologia , COVID-19/terapia , Pessoal de Saúde/educação , Imunização Passiva/normas , Plasma/imunologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Imunização Passiva/métodos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , SARS-CoV-2 , Resultado do TratamentoRESUMO
BACKGROUND: Coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) received an Emergency Use Authorization by the US Food and Drug Administration (FDA). CCP with a signal-to-cutoff ratio ofâ ≥12 using the Ortho VITROS severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin G (IgG) test (OVSARS2IgG) is permitted to be labeled "high titer." Little is known about the relationship between OVSARS2IgG ratio and neutralizing capacity of plasma/sera against genuine SARS-CoV-2. METHODS: Nine hundred eighty-one samples from 196 repeat CCP donors 0-119 days post-initial donation (DPID) were analyzed. Neutralizing capacity was assessed for 50% (PRNT50) and 90% (PRNT90) reduction of infectious virus using the gold standard plaque reduction neutralization test (PRNT). A subset of 91 donations was evaluated by OVSARS2IgG and compared to PRNT titers for diagnostic accuracy. RESULTS: Of donations, 32.7%/79.5% (PRNT90/PRNT50) met a 1:80 titer initially but only 14.0%/48.8% (PRNT90/PRNT50) met this cutoffâ ≥85 DPID. Correlation of OVSARS2IgG results to neutralizing capacity allowed extrapolation to CCP therapy results. CCP with OVSARS2IgG ratios equivalent to a therapeutically beneficial group had neutralizing titers ofâ ≥1:640 (PRNT50) and/orâ ≥1:80 (PRNT90). Specificity and positive predictive value of the OVSARS2IgG for qualifying highly neutralizing CCP was optimal using ratios significantly greater than the FDA cutoff. CONCLUSIONS: This information provides a basis for refining the recommended properties of CCP used to treat COVID-19.
Assuntos
COVID-19/imunologia , COVID-19/terapia , SARS-CoV-2/imunologia , Estudos de Coortes , Feminino , Humanos , Imunização Passiva/normas , Masculino , Pessoa de Meia-Idade , Testes de Neutralização , Estudos Retrospectivos , Sensibilidade e Especificidade , Fatores de Tempo , Soroterapia para COVID-19RESUMO
Highly sensitive and specific platforms for the detection of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies are becoming increasingly important for evaluating potential SARS-CoV-2 convalescent plasma donors, studying the spread of SARS-CoV-2 infections, and identifying individuals with seroconversion. This study provides a comparative validation of 4 anti-SARS-CoV-2 platforms. A unique feature of the study is the use of a representative cohort of convalescent patients with coronavirus disease 2019 and a mild to moderate disease course. All platforms showed significant correlations with a SARS-CoV-2 plaque reduction neutralization test, with highest sensitivities for the Euroimmun and the Roche platforms, suggesting their preferential use for screening persons at increased risk of SARS-CoV-2 infections.
Assuntos
Teste Sorológico para COVID-19/normas , COVID-19/terapia , SARS-CoV-2/imunologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Teste Sorológico para COVID-19/métodos , Estudos de Casos e Controles , Estudos de Coortes , Feminino , Humanos , Imunização Passiva/normas , Masculino , Pessoa de Meia-Idade , Testes de Neutralização , Valor Preditivo dos Testes , Sensibilidade e Especificidade , Doadores de Tecidos , Adulto Jovem , Soroterapia para COVID-19RESUMO
BACKGROUND: The rapidly evolving coronavirus disease 2019 (COVID-19) has resulted in more than 24 million infections and 821 thousand deaths. However, a vaccine or specific drug is absent up to this date and more attention has been focused on the use of convalescent plasma (CP). Several articles have described the CP treatment for patients with SARS-CoV-2 infection. But a comprehensive systematic review with meta-analysis about the safety and efficacy of CP transfusion in SARS-CoV-2-infected patients has not been published. We conducted this study for a better understanding of the therapeutic significance of CP for patients with COVID-19. RESULTS: A fixed-effect model (I2=0.0%) was used on the 9 articles for quantitative analysis showing that the mortality of patients with COVID-19 treated with or without CP was statistically significant (RR=0.57 [0.44-0.74]). Subgroup analysis showed that the severely ill patients benefited more from CP than the critically ill patients. Our study concluded that clinical improvement in severe COVID-19 cases were obvious. Adverse events were few and the effect of convalescent plasma on reducing viral load was apparent. CONCLUSIONS: Convalescent plasma therapy appears safe for COVID-19, and plasma treated patients have marked reductions in their serum viral loads and most are virus negative after transfusion. Patients with severe COVID-19 benefit more from the convalescent plasma transfusion than critical patients, and patients treated in early stage are more likely to survive. METHODS: We reviewed the scientific literature from four databases published from December 8, 2019 to August 20, 2020. Statistical analyses were performed with STATA (version 15.1; Stata Corporation, College Station, TX, USA). The frequency with 95% confidence intervals (CI) was assessed using fixed effect model in analyzing the overall mortality and p <0.05 was considered statistically significant.
Assuntos
COVID-19/terapia , SARS-CoV-2 , Humanos , Imunização Passiva/normas , Soroterapia para COVID-19RESUMO
Effective therapies are urgently needed for the SARS-CoV-2/COVID-19 pandemic. We identified panels of fully human monoclonal antibodies (mAbs) from large phage-displayed Fab, scFv, and VH libraries by panning against the receptor binding domain (RBD) of the SARS-CoV-2 spike (S) glycoprotein. A high-affinity Fab was selected from one of the libraries and converted to a full-size antibody, IgG1 ab1, which competed with human ACE2 for binding to RBD. It potently neutralized replication-competent SARS-CoV-2 but not SARS-CoV, as measured by two different tissue culture assays, as well as a replication-competent mouse ACE2-adapted SARS-CoV-2 in BALB/c mice and native virus in hACE2-expressing transgenic mice showing activity at the lowest tested dose of 2 mg/kg. IgG1 ab1 also exhibited high prophylactic and therapeutic efficacy in a hamster model of SARS-CoV-2 infection. The mechanism of neutralization is by competition with ACE2 but could involve antibody-dependent cellular cytotoxicity (ADCC) as IgG1 ab1 had ADCC activity in vitro. The ab1 sequence has a relatively low number of somatic mutations, indicating that ab1-like antibodies could be quickly elicited during natural SARS-CoV-2 infection or by RBD-based vaccines. IgG1 ab1 did not aggregate, did not exhibit other developability liabilities, and did not bind to any of the 5,300 human membrane-associated proteins tested. These results suggest that IgG1 ab1 has potential for therapy and prophylaxis of SARS-CoV-2 infections. The rapid identification (within 6 d of availability of antigen for panning) of potent mAbs shows the value of large antibody libraries for response to public health threats from emerging microbes.
Assuntos
Teste Sorológico para COVID-19/métodos , Vacinas contra COVID-19/imunologia , COVID-19/terapia , Enzima de Conversão de Angiotensina 2/metabolismo , Animais , Anticorpos Antivirais/sangue , Anticorpos Antivirais/imunologia , Citotoxicidade Celular Dependente de Anticorpos , Teste Sorológico para COVID-19/normas , Vacinas contra COVID-19/normas , Chlorocebus aethiops , Cricetinae , Feminino , Humanos , Imunização Passiva/métodos , Imunização Passiva/normas , Imunogenicidade da Vacina , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Camundongos , Camundongos Endogâmicos BALB C , SARS-CoV-2/imunologia , Glicoproteína da Espícula de Coronavírus/química , Glicoproteína da Espícula de Coronavírus/imunologia , Células Vero , Soroterapia para COVID-19RESUMO
Convalescent plasma (CP) therapy has been used since the early 1900s to treat emerging infectious diseases; its efficacy was later associated with the evidence that polyclonal neutralizing antibodies can reduce the duration of viremia. Recent large outbreaks of viral diseases for which effective antivirals or vaccines are still lacking has renewed the interest in CP as a life-saving treatment. The ongoing COVID-19 pandemic has led to the scaling up of CP therapy to unprecedented levels. Compared with historical usage, pathogen reduction technologies have now added an extra layer of safety to the use of CP, and new manufacturing approaches are being explored. This review summarizes historical settings of application, with a focus on betacoronaviruses, and surveys current approaches for donor selection and CP collection, pooling technologies, pathogen inactivation systems, and banking of CP. We additionally list the ongoing registered clinical trials for CP throughout the world and discuss the trial results published thus far.
Assuntos
Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Anticorpos Neutralizantes/análise , Bancos de Espécimes Biológicos/normas , COVID-19 , Seleção do Doador/métodos , Seleção do Doador/normas , Ensaio de Imunoadsorção Enzimática , Humanos , Imunização Passiva/efeitos adversos , Imunização Passiva/normas , Testes de Neutralização/normas , Pandemias , Síndrome Respiratória Aguda Grave/terapia , Soroterapia para COVID-19RESUMO
BACKGROUND: Convalescent plasma administration may be of clinical benefit in patients with severe influenza, but reports on the efficacy of this therapy vary. METHODS: We conducted a systematic review and meta-analysis assessing randomized controlled trials (RCTs) involving the administration of convalescent plasma to treat severe influenza. Healthcare databases were searched in February 2020. All records were screened against eligibility criteria, and the risks of bias were assessed. The primary outcome was the fatality rate. RESULTS: A total of 2861 studies were retrieved and screened. Five eligible RCTs were identified. Pooled analyses yielded no evidence that using convalescent plasma to treat severe influenza resulted in significant reductions in mortality (odds ratio, 1.06; 95% CI, 0.51-2·23; P = 0.87; I2 = 35%), number of days in the intensive care unit, or number of days on mechanical ventilation. This treatment may have the possible benefits of increasing hemagglutination inhibition titers and reducing influenza B viral loads and cytokine levels. No serious adverse events were reported. The included studies were generally of high quality with a low risk of bias. CONCLUSIONS: The administration of convalescent plasma appears safe but may not reduce the mortality, number of days in the intensive care unit, or number of days on mechanical ventilation in patients with severe influenza.
Assuntos
COVID-19/terapia , Imunização Passiva/normas , Influenza Humana/tratamento farmacológico , Humanos , Imunização Passiva/métodos , Imunização Passiva/estatística & dados numéricos , Influenza Humana/fisiopatologia , Razão de Chances , Soroterapia para COVID-19RESUMO
Background: Many children with Kawasaki disease develop coronary artery lesions before intravenous immunoglobulin treatment. However, little data are available on the prognosis of children with Kawasaki disease who developed coronary artery lesions before intravenous immunoglobulin treatment. Aims: To explore the outcomes of coronary artery lesions before intravenous immunoglobulin treatment in children with Kawasaki disease and analyze the factors that influence the duration of coronary artery lesions. Study Design: Retrospective cohort study. Methods: All patients with Kawasaki disease who developed coronary artery lesions before intravenous immunoglobulin treatment in our hospital from January 2009 to December 2014 were reviewed. A Cox proportional hazards model was used to determine the factors influencing the prognosis of coronary artery lesions. Results: Among 182 patients included, 28.6% were male, 83.50% were younger than 36 months, and 181 exhibited resolution of coronary artery lesions 2 years after disease onset. The median duration of coronary artery lesions was 31 days, and the proportion of coronary artery lesions was 52% at 1 month, 35% at 2 months, 33% at 3 months, 25% at 6 months, 14% at 1 year, and 0.5% at 2 years. The univariate analysis showed that overweight status, higher platelet count, lower albumin level, and starting treatment more than 10 days after disease onset were factors that possibly affect the duration of coronary artery lesions in children. The multivariate Cox regression analysis showed that female sex (adjusted hazard ratio, 1.661; 95% confidence interval, 1.117-2.470) was an independent protective factor, and overweight status (adjusted hazard ratio, 0.469; 95% confidence interval, 0.298-0.737), higher platelet count (adjusted hazard ratio, 0.649; 95% confidence interval, 0.443-0.950), and starting treatment more than 10 days after disease onset (adjusted hazard ratio, 0.392; 95% confidence interval, 0.215-0.716) were independent risk factors for a longer duration of coronary artery lesions. Conclusion: The average duration of coronary artery lesions before intravenous immunoglobulin therapy in children with Kawasaki disease is approximately 1 month. Male gender, overweight status, higher platelet count, and initiation of treatment more than 10 days after the onset of the disease are independent risk factors for longer-lasting coronary artery lesions.
Assuntos
Vasos Coronários/fisiopatologia , Imunização Passiva/normas , Síndrome de Linfonodos Mucocutâneos/tratamento farmacológico , Pré-Escolar , Estudos de Coortes , Vasos Coronários/efeitos dos fármacos , Feminino , Humanos , Imunização Passiva/métodos , Imunização Passiva/estatística & dados numéricos , Lactente , Masculino , Síndrome de Linfonodos Mucocutâneos/complicações , Prognóstico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Fatores de RiscoRESUMO
BACKGROUND: The lack of effective treatments against the 2019 coronavirus disease (COVID-19) has led to the exploratory use of convalescent plasma for treating COVID-19. Case reports and case series have shown encouraging results. This study investigated SARS-CoV-2 antibodies and epidemiological characteristics in convalescent plasma donors, to identify criteria for donor selection. METHODS: Recovered COVID-19 patients, aged 18-55 years, who had experienced no symptoms for more than 2 weeks, were recruited. Donor characteristics such as disease presentations were collected and SARS-CoV-2 N-specific IgM, IgG, and S-RBD-specific IgG levels were measured by enzyme-linked immunosorbent assay (ELISA). RESULTS: Whereas levels of N-specific IgM antibody declined after recovery, S-RBD-specific and N-specific IgG antibodies increased after 4 weeks from the onset of symptoms, with no significant correlation to age, sex, or ABO blood type. Donors with the disease presentation of fever exceeding 38.5°C or lasting longer than 3 days exhibited higher levels of S-RBD-specific IgG antibodies at the time of donation. Of the 49 convalescent plasma donors, 90% had an S-RBD-specific IgG titer of ≥1:160 and 78% had a titer of ≥1:640 at the time of plasma donation. Of the 30 convalescent plasma donors, who had donated plasma later than 28 days after the onset of symptoms and had a disease presentation of fever lasting longer than 3 days or a body temperature exceeding 38.5°C, 100% had an S-RBD-specific IgG titer of ≥1:160 and 93% had a titer of ≥1:640. CONCLUSION: This study indicates that the S-RBD-specific IgG antibody reaches higher levels after 4 weeks from the onset of COVID-19 symptoms. We recommend the following selection criteria for optimal donation of COVID-19 convalescent plasma: 28 days after the onset of symptoms and with a disease presentation of fever lasting longer than 3 days or a body temperature exceeding 38.5°C. Selection based on these criteria can ensure a high likelihood of achieving sufficiently high S-RBD-specific IgG titers.
Assuntos
Anticorpos Antivirais/sangue , Betacoronavirus/imunologia , Doadores de Sangue , Convalescença , Infecções por Coronavirus/sangue , Pneumonia Viral/sangue , Adolescente , Adulto , COVID-19 , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/patologia , Infecções por Coronavirus/terapia , Febre , Humanos , Imunização Passiva/normas , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/imunologia , Pneumonia Viral/patologia , SARS-CoV-2 , Glicoproteína da Espícula de Coronavírus/imunologia , Fatores de Tempo , Soroterapia para COVID-19Assuntos
Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/terapia , Aprovação de Equipamentos , Aprovação de Teste para Diagnóstico , Aprovação de Drogas , União Europeia , Pneumonia Viral/diagnóstico , Pneumonia Viral/terapia , Antibacterianos , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticoagulantes/uso terapêutico , Antimaláricos/uso terapêutico , Antivirais/uso terapêutico , Azitromicina/uso terapêutico , Betacoronavirus , Pesquisa Biomédica , COVID-19 , Teste para COVID-19 , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Confiabilidade dos Dados , Controle de Medicamentos e Entorpecentes , Glucocorticoides/uso terapêutico , Heparina/uso terapêutico , Humanos , Imunização Passiva/normas , Legislação de Dispositivos Médicos , Pandemias , Equipamento de Proteção Individual/normas , Pneumonia Viral/epidemiologia , SARS-CoV-2 , Ventiladores Mecânicos/normas , Tratamento Farmacológico da COVID-19 , Soroterapia para COVID-19RESUMO
Despite initial findings indicating that SARS-CoV and SARS-CoV-2 are genetically related belonging to the same virus species and that the two viruses used the same entry receptor, angiotensin-converting enzyme 2 (ACE2), our data demonstrated that there is no detectable cross-neutralization by SARS patient sera against SARS-CoV-2. We also found that there are significant levels of neutralizing antibodies in recovered SARS patients 9-17 years after initial infection. These findings will be of significant use in guiding the development of serologic tests, formulating convalescent plasma therapy strategies, and assessing the longevity of protective immunity for SARS-related coronaviruses in general as well as vaccine efficacy.