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1.
Clin J Oncol Nurs ; 25(1): 28-32, 2021 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-33480877

RESUMO

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 , /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 , Resultado do Tratamento
2.
PLoS One ; 15(12): e0243967, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33351831

RESUMO

The ongoing coronavirus disease 2019 (COVID-19) pandemic emerged in December 2019. Convalescent plasma represents a promising COVID-19 treatment. Here, we report on the manufacturing of a plasma-based product containing antibodies specific to SARS-CoV-2 obtained from recently recovered COVID-19 patients. Convalescent plasma donors were screened as follows: 1) previously confirmed SARS-CoV-2 infection (by real-time PCR (RT-PCR)); 2) a subsequent negative PCR test followed by a 2-week waiting period; 3) an additional negative PCR test prior to plasmapheresis; and 4) confirmation of the presence of SARS-CoV-2 specific antibodies. Convalescent plasma was stored fresh (2-6°C) for up to 5 days or frozen (-30°C) for long-term storage. Donor peripheral blood and final plasma product were assayed for binding antibodies targeting the SARS-CoV-2 S-protein receptor-binding domain (RBD) and their titers measured by an enzyme-linked immunosorbent assay (ELISA). We performed 72 plasmaphereses resulting in 248 final products. Convalescent plasma contained an RBD-specific antibody titer (IgG) ranging from 1:100 to 1:3200 (median 1:800). The titer was congruent to the titer of the blood (n = 34) before collection (1:100-1:6400, median 1:800). Levels of IL-8 and LBP of donors were slightly increased. Therapeutic products derived from a human origin must undergo rigorous testing to ensure uniform quality and patient safety. Whilst previous publications recommended RBD-specific binding antibody titers of ≥ 1:320, we selected a minimum titer of 1:800 in order to maximize antibody delivery. Production of highly standardized convalescent plasma was safe, feasible and was readily implemented in the treatment of severely ill COVID-19 patients.


Assuntos
Anticorpos Antivirais/sangue , /terapia , Adolescente , Adulto , Anticorpos Antivirais/imunologia , /epidemiologia , Ensaio de Imunoadsorção Enzimática , Feminino , Humanos , Imunização Passiva , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Imunoglobulina M/sangue , Imunoglobulina M/imunologia , Masculino , Pessoa de Meia-Idade , Testes de Neutralização , Pandemias , Plasma/imunologia , Plasma/virologia , Plasmaferese/métodos , Doadores de Tecidos , Adulto Jovem
3.
Viruses ; 13(1)2020 12 25.
Artigo em Inglês | MEDLINE | ID: mdl-33375675

RESUMO

Immune profiling of patients with COVID-19 has shown that SARS-CoV-2 causes severe lymphocyte deficiencies (e.g., lymphopenia, decreased numbers, and exhaustion of T cells) and increased levels of pro-inflammatory monocytes. Peripheral blood (PB) samples from convalescent plasma (CP) donors, COVID-19 patients, and control subjects were analyzed by multiparametric flow cytometry, allowing the identification of a wide panel of immune cells, comprising lymphocytes (T, B, natural killer (NK) and NKT cells), monocytes, granulocytes, and their subsets. Compared to active COVID-19 patients, our results revealed that the immune profile of recovered donors was restored for most subpopulations. Nevertheless, even 2 months after recovery, CP donors still had reduced levels of CD4+ T and B cells, as well as granulocytes. CP donors with non-detectable levels of anti-SARS-CoV-2-specific antibodies in their serum were characterized by higher Th9 and Th17 cells, which were possibly expanded at the expense of Th2 humoral immunity. The most noticeable alterations were identified in previously hospitalized CP donors, who presented the lowest levels of CD8+ regulatory T cells, the highest levels of CD56+CD16- NKT cells, and a promotion of a Th17-type phenotype, which might be associated with a prolonged pro-inflammatory response. A longer follow-up of CP donors will eventually reveal the time needed for full recovery of their immune system competence.


Assuntos
Anticorpos Antivirais/sangue , Plasma/imunologia , /imunologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Linfócitos B , Linfócitos T CD4-Positivos , Linfócitos T CD8-Positivos , Feminino , Humanos , Imunidade Humoral , Imunização Passiva , Masculino , Pessoa de Meia-Idade , Células Th1 , Células Th17 , Células Th2 , Fatores de Tempo , Adulto Jovem
4.
Front Immunol ; 11: 570063, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33072111

RESUMO

Coronavirus disease 2019 (COVID-19) is a pandemic caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Most infected people have mild or moderate symptoms and recover without the need for extensive treatment. However, for seriously ill patients, no specific treatments are currently available. Convalescent plasma therapy (CPT), a passive immunotherapy, involves infusing plasma from recovered people into actively infected people, and is thought to be a specific intervention to improve outcome in patients with severe COVID-19. The presumed mechanism involves neutralizing antibodies and antibody dependent cytotoxicity/phagocytosis. Previous CPT trials showed an effect in SARS and pilot studies suggest CPT is an effective and safe strategy for seriously ill COVID-19 patients. CPT is currently being tested in large randomized clinical trials. Herein, we critically review the mechanism, applications and the challenges for CPT in the treatment of severe COVID-19, paving the way toward vaccine and immunotherapy development.


Assuntos
Anticorpos Neutralizantes , Anticorpos Antivirais , Betacoronavirus/imunologia , Infecções por Coronavirus , Pandemias , Pneumonia Viral , Anticorpos Neutralizantes/imunologia , Anticorpos Neutralizantes/uso terapêutico , Anticorpos Antivirais/imunologia , Anticorpos Antivirais/uso terapêutico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/terapia , Humanos , Imunização Passiva , Plasma/imunologia , Pneumonia Viral/epidemiologia , Pneumonia Viral/imunologia , Pneumonia Viral/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
Trials ; 21(1): 828, 2020 Oct 06.
Artigo em Inglês | MEDLINE | ID: mdl-33023671

RESUMO

OBJECTIVES: Primary objectives • To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care. Secondary objectives • To assess overall survival, and the overall survival rate at 28 56 and 84 days. • To assess SARS-CoV-2 viral clearance and load as well as antibody titres. • To assess the percentage of patients that required mechanical ventilation. • To assess time from randomisation until discharge. TRIAL DESIGN: Randomised, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent plasma or standard of care. PARTICIPANTS: High-risk patients >18 years of age hospitalized with SARS-CoV-2 infection in 10-15 university medical centres will be included. High-risk is defined as SARS-CoV-2 positive infection with Oxygen saturation at ≤ 94% at ambient air with additional risk features as categorised in 4 groups: • Group 1, pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less. • Group 2, chronic immunosuppression not meeting the criteria of group 1. • Group 3, age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 and at least one of these criteria: Lymphopenia < 0.8 x G/l and/or D-dimer > 1µg/mL. • Group 4, age ≥ 75 years meeting neither the criteria of group 1 nor group 2. Observation time for all patients is expected to be at least 3 months after entry into the study. Patients receive convalescent plasma for two days (day 1 and day 2) or standard of care. For patients in the standard arm, cross over is allowed from day 10 in case of not improving or worsening clinical condition. Nose/throat swabs for determination of viral load are collected at day 0 and day 1 (before first CP administration) and subsequently at day 2, 3, 5, 7, 10, 14, 28 or until discharge. Serum for SARS-Cov-2 diagnostic is collected at baseline and subsequently at day 3, 7, 14 and once during the follow-up period (between day 35 and day 84). There is a regular follow-up of 3 months. All discharged patients are followed by regular phone calls. All visits, time points and study assessments are summarized in the Trial Schedule (see full protocol Table 1). All participating trial sites will be supplied with study specific visit worksheets that list all assessments and procedures to be completed at each visit. All findings including clinical and laboratory data are documented by the investigator or an authorized member of the study team in the patient's medical record and in the electronic case report forms (eCRFs). INTERVENTION AND COMPARATOR: This trial will analyze the effects of convalescent plasma from recovered subjects with SARS-CoV-2 antibodies in high-risk patients with SARS-CoV-2 infection. Patients at high risk for a poor outcome due to underlying disease, age or condition as listed above are eligible for enrollment. In addition, eligible patients have a confirmed SARS-CoV-2 infection and O2 saturation ≤ 94% while breathing ambient air. Patients are randomised to receive (experimental arm) or not receive (standard arm) convalescent plasma in two bags (238 - 337 ml plasma each) from different donors (day 1, day 2). A cross over from the standard arm into the experimental arm is possible after day 10 in case of not improving or worsening clinical condition. MAIN OUTCOMES: Primary endpoints: The main purpose of the study is to assess the time from randomisation until an improvement within 84 days defined as two points on a seven-point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of a SARS-CoV-2 infection or standard of care. Secondary endpoints: • Overall survival, defined as the time from randomisation until death from any cause 28-day, 56-day and 84-day overall survival rates. • SARS-CoV-2 viral clearance and load as well as antibody titres. • Requirement mechanical ventilation at any time during hospital stay (yes/no). • Time until discharge from randomisation. • Viral load, changes in antibody titers and cytokine profiles are analysed in an exploratory manner using paired non-parametric tests (before - after treatment). RANDOMISATION: Upon confirmation of eligibility (patients must meet all inclusion criteria and must not meet exclusion criteria described in section 5.3 and 5.4 of the full protocol), the clinical site must contact a centralized internet randomization system ( https://randomizer.at/ ). Patients are randomized using block randomisation to one of the two arms, experimental arm or standard arm, in a 1:1 ratio considering a stratification according to the 4 risk groups (see Participants). BLINDING (MASKING): The study is open-label, no blinding will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total number of 174 patients is required for the entire trial, n=87 per group. TRIAL STATUS: Protocol version 1.2 dated 09/07/2020. A recruitment period of approximately 9 months and an overall study duration of approximately 12 months is anticipated. Recruitment of patients starts in the third quarter of 2020. The study duration of an individual patient is planned to be 3 months. After finishing all study-relevant procedures, therapy, and follow-up period, the patient is followed in terms of routine care and treated if necessary. Total trial duration: 18 months Duration of the clinical phase: 12 months First patient first visit (FPFV): 3rd Quarter 2020 Last patient first visit (LPFV): 2nd Quarter 2021 Last patient last visit (LPLV): 3rd Quarter 2021 Trial Report completed: 4th Quarter 2021 TRIAL REGISTRATION: EudraCT Number: 2020-001632-10, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE , registered on 04/04/2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). The eCRF is attached (Additional file 3).


Assuntos
Anticorpos Antivirais/sangue , Betacoronavirus , Infecções por Coronavirus , Pandemias , Plasma/imunologia , Pneumonia Viral , Idoso , Betacoronavirus/imunologia , Betacoronavirus/isolamento & purificação , Ensaios Clínicos Fase II como Assunto , Convalescença , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/terapia , Feminino , Humanos , Imunização Passiva/métodos , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica/métodos , Estudos Multicêntricos como Assunto , Pneumonia Viral/diagnóstico , Pneumonia Viral/imunologia , Pneumonia Viral/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco Ajustado , Índice de Gravidade de Doença
6.
Infez Med ; 28(3): 357-366, 2020 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-32920571

RESUMO

The current COVID-19 pandemic needs unconventional therapies to tackle the resulted high morbidity and mortality. Convalescent plasma is one of the therapeutic approaches that might be of benefit. Forty nine early-stage critically-ill COVID-19 patients residing in Respiratory Care Units (RCU) of three hospitals in Baghdad, Iraq, were included: 21 received convalescent plasma while 28, namely control group, did not receive it. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease were monitored clinically along with laboratory monitoring through SARS-CoV-2 RNA detection via PCR, and SARS-CoV-2 IgG and IgM serological monitoring. Patients who received convalescent plasma showed reduced duration of infection in about 4 days and showed less death rate [1/21 versus 8/28 in control group]. In addition, all the patients who were given convalescent plasma showed high levels of SARS-CoV-2 IgG and IgM three days after plasma transfusion. Plasma from donors with high levels of SARS-CoV-2 IgG and donors with positive SRAS-CoV-2 IgM showed better therapeutic results than other donors. Convalescent plasma therapy is an effective therapy if donors with high level of SARS-Cov2 antibodies are selected and if recipients are at their early stage of critical illness, being no more than three days in RCUs.


Assuntos
Betacoronavirus/imunologia , Infecções por Coronavirus/terapia , Plasma/imunologia , Pneumonia Viral/terapia , Anticorpos Antivirais/sangue , Estudos de Casos e Controles , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/imunologia , Estado Terminal/terapia , Feminino , Humanos , Imunização Passiva/métodos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Iraque/epidemiologia , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/epidemiologia , Pneumonia Viral/imunologia
7.
Sanid. mil ; 76(3): 192-194, jul.-sept. 2020. ilus
Artigo em Espanhol | IBECS | ID: ibc-196233

RESUMO

Desde hace tiempo se utilizan tratamientos para algunas enfermedades infecciosas con plasma hiperinmune de donantes convalecientes de esa enfermedad con resultados prometedores. Ante la pandemia de COVID-19 se plantea su eficacia dado que no existen tratamientos óptimos para abordar la enfermedad. El Comité Científico de Seguridad Transfusional del Ministerio de Sanidad permite la realización de ensayos clínicos y estudios observacionales para avanzar en este terreno mientras se obtiene un tratamiento eficaz


Treatments for some infectious diseases with hyperimmune plasma from convalescent donors of this disease have been used for some time with promising results. In the face of the COVID-19 pandemic, its efficacy arises since there are no optimal treatments to tackle the disease. The Scientific Committee on Transfusion Safety of the Ministry of Health allows clinical trials and observational studies to be carried out to advance in this field while obtaining effective treatment


Assuntos
Humanos , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/terapia , Pneumonia Viral/imunologia , Pneumonia Viral/terapia , Plasma/imunologia , Betacoronavirus , Doadores de Sangue
8.
Mil. med. res. (Lond.) ; 7(41): 1-33, Sept. 04, 2020.
Artigo em Inglês | BIGG - guias GRADE | ID: biblio-1129883

RESUMO

The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of a rapidly spreading illness, coronavirus disease 2019 (COVID-19), affecting more than seventeen million people around the world. Diagnosis and treatment guidelines for clinicians caring for patients are needed. In the early stage, we have issued "A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version)"; now there are many direct evidences emerged and may change some of previous recommendations and it is ripe for develop an evidence-based guideline. We formed a working group of clinical experts and methodologists. The steering group members proposed 29 questions that are relevant to the management of COVID-19 covering the following areas: chemoprophylaxis, diagnosis, treatments, and discharge management. We searched the literature for direct evidence on the management of COVID-19, and assessed its certainty generated recommendations using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Recommendations were either strong or weak, or in the form of ungraded consensus-based statement. Finally, we issued 34 statements. Among them, 6 were strong recommendations for, 14 were weak recommendations for, 3 were weak recommendations against and 11 were ungraded consensus-based statement. They covered topics of chemoprophylaxis (including agents and Traditional Chinese Medicine (TCM) agents), diagnosis (including clinical manifestations, reverse transcription-polymerase chain reaction (RT-PCR), respiratory tract specimens, IgM and IgG antibody tests, chest computed tomography, chest x-ray, and CT features of asymptomatic infections), treatments (including lopinavir-ritonavir, umifenovir, favipiravir, interferon, remdesivir, combination of antiviral drugs, hydroxychloroquine/chloroquine, interleukin-6 inhibitors, interleukin-1 inhibitors, glucocorticoid, qingfei paidu decoction, lianhua qingwen granules/capsules, convalescent plasma, lung transplantation, invasive or noninvasive ventilation, and extracorporeal membrane oxygenation (ECMO)), and discharge management (including discharge criteria and management plan in patients whose RT-PCR retesting shows SARS-CoV-2 positive after discharge). We also created two figures of these recommendations for the implementation purpose. We hope these recommendations can help support healthcare workers caring for COVID19 patients


Assuntos
Humanos , Adulto , Plasma/imunologia , Pneumonia Viral/diagnóstico , Pneumonia Viral/tratamento farmacológico , Cloroquina/uso terapêutico , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/tratamento farmacológico , Quimioprevenção/métodos , Receptores de Interleucina-6/uso terapêutico , Antirretrovirais/uso terapêutico , Pandemias/prevenção & controle , Lopinavir/uso terapêutico , Betacoronavirus/efeitos dos fármacos , Hidroxicloroquina/uso terapêutico , Prática Clínica Baseada em Evidências/métodos
9.
PLoS Pathog ; 16(8): e1008791, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32841299

RESUMO

During antiretroviral therapy (ART) that suppresses HIV replication to below the limit-of-quantification, virions produced during ART can be detected at low frequencies in the plasma, termed residual viremia (RV). We hypothesized that a reservoir of HIV-infected cells actively produce and release virions during ART that are potentially infectious, and that following ART-interruption, these virions can complete full-cycles of replication and contribute to rebound viremia. Therefore, we studied the dynamics of RV sequence variants in 3 participants who initiated ART after ~3 years of infection and were ART-suppressed for >6 years prior to self-initiated ART-interruptions. Longitudinal RV C2V5env sequences were compared to sequences from pre-ART plasma, supernatants of quantitative viral outgrowth assays (QVOA) of cells collected during ART, post-ART-interruption plasma, and ART-re-suppression plasma. Identical, "putatively clonal," RV sequences comprised 8-84% of sequences from each timepoint. The majority of RV sequences were genetically similar to those from plasma collected just prior to ART-initiation, but as the duration of ART-suppression increased, an increasing proportion of RV variants were similar to sequences from earlier in infection. Identical sequences were detected in RV over a median of 3 years (range: 0.3-8.2) of ART-suppression. RV sequences were identical to pre-ART plasma viruses (5%), infectious viruses induced in QVOA (4%) and rebound viruses (5%) (total n = 21/154 (14%) across the 3 participants). RV sequences identical to ART-interruption "rebound" sequences were detected 0.1-7.4 years prior to ART-interruption. RV variant prevalence and persistence were not associated with detection of the variant among rebound sequences. Shortly after ART-re-suppression, variants that had been replicating during ART-interruptions were detected as RV (n = 5). These studies show a dynamic, virion-producing HIV reservoir that contributes to rekindling infection upon ART-interruption. The persistence of identical RV variants over years suggests that a subpopulation of HIV-infected clones frequently or continuously produce virions that may resist immune clearance; this suggests that cure strategies should target this active as well as latent reservoirs.


Assuntos
Antirretrovirais/uso terapêutico , Linfócitos T CD4-Positivos/imunologia , Infecções por HIV/imunologia , HIV-1/imunologia , Plasma/virologia , Viremia/epidemiologia , Replicação Viral , Linfócitos T CD4-Positivos/efeitos dos fármacos , Linfócitos T CD4-Positivos/virologia , Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , HIV-1/efeitos dos fármacos , HIV-1/genética , Humanos , Incidência , Plasma/efeitos dos fármacos , Plasma/imunologia , Estudos Retrospectivos , Estados Unidos/epidemiologia , Carga Viral , Viremia/virologia , Latência Viral , Suspensão de Tratamento
10.
J Immunol Methods ; 486: 112837, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32828791

RESUMO

Coronavirus Disease 2019 (COVID-19) convalescent plasma (CCP) was approved by the FDA for use in severe cases of COVID-19 under an emergency Investigational New Drug (IND) protocol. Eligibility criteria for CCP donors includes documentation of evidence of COVID-19 either by viral RNA detection at the time of illness or positive SARS-CoV-2 IgG after recovery if diagnostic testing for COVID-19 was not performed at the time of illness. In addition to analysis of CCP, analysis of SARS-CoV-2 IgG provides information for possible past exposure and may support diagnosis when SARS-CoV-2 PCR is negative and clinical suspicion for COVID-19 is high. Furthermore, assays with high sensitivity and specificity for SARS-CoV-2 IgG are critical for understanding community exposure rates to SARS-CoV-2. Currently, there are several assays that test for antibodies to SARS-CoV-2 using a variety of methods, including point-of-care lateral flow-based devices, high throughput immunoassay analyzers, and manual methods such as ELISA. These assays target a number of SARS-CoV-2 antigens, including the nucleocapsid protein (N), full length spike protein (S), S1 subunit, or receptor binding domain (RBD) of the S protein. Given the heterogeneity among methods for, and antigenic targets used in SARS-CoV-2 antibody assays, it is necessary for careful evaluation of these assays prior to implementation for clinical use. We compared two assays that had received the CE mark of regulatory approval and that used either the N antigen or S1-RBD antigen as the target for analysis of a large set of CCP samples. Our data indicates that sensitivity and specificity vary between these assays and that more than one antigenic target may be required to improve the sensitivity and specificity of IgG detection to SARS-CoV-2.


Assuntos
Betacoronavirus/imunologia , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Kit de Reagentes para Diagnóstico , Anticorpos Antivirais/sangue , Anticorpos Antivirais/imunologia , Anticorpos Antivirais/isolamento & purificação , Antígenos Virais/imunologia , Betacoronavirus/genética , Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/sangue , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/imunologia , Humanos , Imunização Passiva/métodos , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Imunoglobulina G/isolamento & purificação , Proteínas do Nucleocapsídeo/imunologia , Pandemias , Fosfoproteínas , Plasma/imunologia , Pneumonia Viral/sangue , Pneumonia Viral/diagnóstico , Pneumonia Viral/imunologia , RNA Viral/isolamento & purificação , Sensibilidade e Especificidade , Testes Sorológicos/instrumentação , Testes Sorológicos/métodos , Glicoproteína da Espícula de Coronavírus/imunologia
12.
Am J Pathol ; 190(11): 2290-2303, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32795424

RESUMO

Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2, has spread globally, and proven treatments are limited. Transfusion of convalescent plasma collected from donors who have recovered from COVID-19 is among many approaches being studied as potentially efficacious therapy. We are conducting a prospective, propensity score-matched study assessing the efficacy of COVID-19 convalescent plasma transfusion versus standard of care as treatment for severe and/or critical COVID-19. We present herein the results of an interim analysis of 316 patients enrolled at Houston Methodist hospitals from March 28 to July 6, 2020. Of the 316 transfused patients, 136 met a 28-day outcome and were matched to 251 non-transfused control COVID-19 patients. Matching criteria included age, sex, body mass index, comorbidities, and baseline ventilation requirement 48 hours from admission, and in a second matching analysis, ventilation status at day 0. Variability in the timing of transfusion relative to admission and titer of antibodies of plasma transfused allowed for analysis in specific matched cohorts. The analysis showed a significant reduction (P = 0.047) in mortality within 28 days, specifically in patients transfused within 72 hours of admission with plasma with an anti-spike protein receptor binding domain titer of ≥1:1350. These data suggest that treatment of COVID-19 with high anti-receptor binding domain IgG titer convalescent plasma is efficacious in early-disease patients.


Assuntos
Betacoronavirus/patogenicidade , Infecções por Coronavirus/mortalidade , Plasma/imunologia , Pneumonia Viral/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Transfusão de Componentes Sanguíneos/métodos , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/terapia , Infecções por Coronavirus/virologia , Feminino , Humanos , Imunização Passiva/mortalidade , Masculino , Pessoa de Meia-Idade , Pandemias , Plasma/virologia , Pneumonia Viral/diagnóstico , Pneumonia Viral/virologia , Estudos Prospectivos
15.
J Intensive Care Med ; 35(9): 827-835, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32666875

RESUMO

In the 5 months since initial reports of COVID-19 came to light, the death toll due to SARS-CoV-2 has rapidly increased. The morbidity and mortality of the infection varies based upon patient age, comorbid conditions, viral load, and the availability of effective treatments. Findings from limited autopsies, clinical observations, and laboratory data suggest that high cytokine levels and a procoagulant state can precipitate acute respiratory distress syndrome and multi-organ dysfunction syndrome in critically ill patients. To complicate matters, comorbidities may affect the response to medical treatments currently in use, all of which are still in trial phase. Therapeutic plasma exchange (TPE) merits consideration in the treatment of critically ill COVID-19 patients and is an avenue for clinical trials to pursue. If efficacious, faster recovery of patients may lead to shorter intensive care unit stays and less time on mechanical ventilation. Herein, we briefly discuss some of the various approaches currently being investigated for the treatment of SARS-CoV-2 with a focus on potential benefits of TPE for selected critically ill patients.


Assuntos
Infecções por Coronavirus/imunologia , Infecções por Coronavirus/terapia , Estado Terminal/terapia , Troca Plasmática/métodos , Plasma/imunologia , Pneumonia Viral/imunologia , Pneumonia Viral/terapia , Betacoronavirus , Humanos , Pandemias
16.
Washington; Organización Panamericana de la Salud; 2020; 20200729. 115 p.
Monografia em Inglês, Espanhol | BIGG - guias GRADE | ID: biblio-1116760

RESUMO

Esta guía de práctica clínica provee recomendaciones informadas por la evidencia para la identificación de marcadores y factores de riesgo de mortalidad de los pacientes críticos, control de la infección, recolección de muestras, cuidado de soporte (ventilatorio y hemodinámico), tratamiento farmacológico, rehabilitación temprana, uso de imágenes diagnósticas, prevención de complicaciones y criterios de egreso. Las recomendaciones están dirigidas a todo el personal de salud que atiende a los pacientes en el servicio de urgencias y de emergencias y la unidad de cuidados intensivos (médicos especialistas en medicina de urgencias, neumología, medicina intensiva, medicina interna, anestesiología, infectología, terapistas respiratorios, terapistas físicos, enfermeras y químicos farmacéuticos). La guía está elaborada para su uso por tomadores de decisiones y miembros de entidades gubernamentales relacionados con el manejo de pacientes con COVID-19 en las UCI de la Región de las Américas.


These clinical practice guidelines (short version) were developed in order to provide recommendations for the management of critically ill adult patients with COVID-19 treated in intensive care units (ICUs). These clinical practice guidelines provide evidence-informed recommendations for identifying markers and mortality risk factors in critically ill patients, as well as infection control, sample collection, supportive care (respiratory and hemodynamic), pharmacological treatment, early rehabilitation, diagnostic imaging use, prevention of complications, and discharge requirements. The recommendations are for all healthcare staff who deal with patients in emergency departments and ICUs. These guidelines are also intended for use by decision-makers and government entities involved in the management of patients with COVID-19 in ICUs in the Region of the Americas. This document is the result of a rapid guideline adaptation process. The information presented reflects published evidence as of the date of inclusion in the document. The recommendations are based on the evidence available and the quality thereof (GRADE methodology) at the time the guidelines were published. However, PAHO recognizes that there are numerous research projects under way and will periodically update these reviews and the applicable recommendations.


Assuntos
Humanos , Adulto , Administração dos Cuidados ao Paciente/organização & administração , Infecções por Coronavirus/complicações , Infecções por Coronavirus/tratamento farmacológico , Cuidados Críticos , Betacoronavirus , Unidades de Terapia Intensiva/organização & administração , Antivirais/uso terapêutico , Plasma/imunologia , Pneumonia Viral/complicações , Pneumonia Viral/tratamento farmacológico , Assistência Centrada no Paciente/organização & administração , Fatores Imunológicos/uso terapêutico , Antibacterianos/uso terapêutico
17.
Caracas; Observatorio Nacional de Ciencia, Tecnología e Innovación; 9 jul. 2020. 15-31 p. (Observador del Conocimiento. Revista Especializada en Gestión Social del Conocimiento, 5, 2).
Monografia em Espanhol | LILACS, LIVECS | ID: biblio-1119053

RESUMO

En diciembre 2019, en Wuhan, China, se registró un aumento inusual de casos de infección respiratoria aguda de rápida progresión y alta letalidad. Al poco tiempo es identificado el agente causal, un coronavirus denominado SARS-CoV-2 y se caracteriza una nueva enfermedad, COVID-19. En ausencia hasta el momento de tratamientos específicos, eficaces y seguros, se justifica explorar alternativas científicamente fundamentadas a nuestro alcance como el uso de Plasma de Convaleciente (PC-CoV19) como coadyuvante para el tratamiento de la COVID-19. El plasma de pacientes recuperados de una enfermedad infecciosa, Plasma de Convaleciente, ha sido utilizado en el tratamiento de patologías infecciosas. Hay antecedentes inmediatos de su uso en enfermedades producidas por otro tipo de coronavirus y se registran experiencias y estudios clínicos con resultados preliminares durante esta pandemia. Quimbiotec, empresa productora de hemoderivados y fármacos recombinantes del Estado venezolano, y el Banco Municipal de Sangre, definen un protocolo para promover condiciones para la aféresis, procesamiento, conservación, almacenamiento, distribución, transfusión y evaluación de la seguridad y eficacia del PC-CoV19 como alternativa en el tratamiento de la COVID-19 en Venezuela. Se incluye la identificación de capacidades y de talento, la estructura física, equipos y especialistas necesarios, así como la definición de procesos para establecer rutinas controladas y auditables para sentar bases del acceso y uso del PC-CoV19 en el Sistema Nacional de Salud de Venezuela y preparar el diseño y ejecución de estudios clínicos. Se presenta el Protocolo y algunos nudos críticos en su ejecución a la fecha, herramientas y estrategias utilizadas para su solución(AU)


On December 2019, in Wuhan, China, there was an unusual increase in cases of a fast-progressing acute respiratory infection with high fatality rate. Soon after, the causing agent is identiied, a coronavirus called SARS-CoV-2, and a new disease, COVID-19 is characterized. Currently, in the absence of specific, effective and safe treatments, it is justified to explore all scientifically based alternatives available to us, such as the use of Convalescent Plasma (PC-CoV19) as acoadjutant treatment of COVID-19.Plasma from patients who have recovered from an infectious disease, Convalescent Plasma, has been used in the treatment of other infectious disease. There is recent history of its use in diseases caused by another type of coronavirus, and clinical experiences and studies have already been published with preliminary results during this pandemic. Quimbiotec, a Venezuelan State public company that produces blood products and recombinant drugs, and Banco Municipal de Sangre, deined a protocol to promote conditions for aphaeresis, processing, conservation, storage, distribution, transfusion, and evaluation of safety and eficacy of PC-CoV19 as an alternative for the treatment of COVID-19 in Venezuela. This protocol includes identification of capacities, physical structure, equipment and skills, talent, professionals needed, as well as a definition of processes to establish controlled and auditable routines to lay the foundations for access and use of PC-CoV19 in the Venezuela Health System, and prepare the design and implementation of clinical studies. The protocol and currently critical points in its implementation, as well as tools and strategies used for its solution, are presented(AU)


Assuntos
Humanos , Plasma/imunologia , Venezuela , Infecções por Coronavirus/prevenção & controle , Aprovação de Teste para Diagnóstico
18.
BMJ Open ; 10(6): e039978, 2020 06 09.
Artigo em Inglês | MEDLINE | ID: mdl-32518212

RESUMO

OBJECTIVES: The coronavirus disease 2019 (COVID-19) pandemic has prompted many initiatives to identify safe and efficacious treatments, yet little is known regarding where early efforts have focused. We aimed to characterise registered clinical trials assessing drugs or plasma treatments for COVID-19. DESIGN, SETTING AND PARTICIPANTS: Cross-sectional analysis of clinical trials for the treatment of COVID-19 that were registered in the USA or in countries contributing to the WHO's International Clinical Trials Registry Platform. Relevant trial entries of drugs or plasma were downloaded on 26 March 2020, deduplicated, verified with reviews of major medical journals and WHO websites and independently analysed by two reviewers. MAIN OUTCOMES: Trial intervention, sponsorship, critical design elements and specified outcomes RESULTS: Overall, 201 clinical trials were registered for testing the therapeutic benefits of 92 drugs or plasma, including 64 in monotherapy and 28 different combinations. Only eight (8.7%) products or combinations involved new molecular entities. The other test therapies had a wide range of prior medical uses, including as antivirals, antimalarials, immunosuppressants and oncology treatments. In 152 trials (75.7%), patients were randomised to treatment or comparator, including 55 trials with some form of blinding and 97 open-label studies. The 49 (24.4%) of trials without a randomised design included 29 single armed studies and 20 trials with some comparison group. Most trial designs featured multiple endpoints. Clinical endpoints were identified in 134 (66.7%) of trials and included COVID-19 symptoms, death, recovery, required intensive care and hospital discharge. Clinical scales were being used in 33 (16.4%) trials, most often measures of oxygenation and critical illness. Surrogate endpoints or biomarkers were studied in 88 (42.3%) of trials, primarily assays of viral load. Although the trials were initiated in more than 17 countries or regions, 100 (49.8%) were registered in China and 78 (37.8%) in the USA. Registered trials increased rapidly, with the number of registered trials doubling from 1 March to 26 March 2020. CONCLUSIONS: While accelerating morbidity and mortality from the COVID-19 pandemic has been paralleled by early and rapid clinical investigation, many trials lack features to optimise their scientific value. Global coordination and increased funding of high-quality research may help to maximise scientific progress in rapidly discovering safe and effective treatments.


Assuntos
Antimaláricos/farmacologia , Antineoplásicos/farmacologia , Antivirais/farmacologia , Ensaios Clínicos como Assunto , Infecções por Coronavirus , Imunização Passiva/métodos , Imunossupressores/farmacologia , Pandemias , Plasma/imunologia , Pneumonia Viral , Betacoronavirus/isolamento & purificação , Ensaios Clínicos como Assunto/classificação , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Ensaios Clínicos como Assunto/estatística & dados numéricos , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Estudos Transversais , Humanos , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Sistema de Registros/estatística & dados numéricos , Terapias em Estudo/métodos , Terapias em Estudo/estatística & dados numéricos
19.
Am Heart J ; 226: 29-44, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32497913

RESUMO

Although coronavirus disease 2019 (COVID-19) predominantly disrupts the respiratory system, there is accumulating experience that the disease, particularly in its more severe manifestations, also affects the cardiovascular system. Cardiovascular risk factors and chronic cardiovascular conditions are prevalent among patients affected by COVID-19 and associated with adverse outcomes. However, whether pre-existing cardiovascular disease is an independent determinant of higher mortality risk with COVID-19 remains uncertain. Acute cardiac injury, manifest by increased blood levels of cardiac troponin, electrocardiographic abnormalities, or myocardial dysfunction, occurs in up to ~60% of hospitalized patients with severe COVID-19. Potential contributors to acute cardiac injury in the setting of COVID-19 include (1) acute changes in myocardial demand and supply due to tachycardia, hypotension, and hypoxemia resulting in type 2 myocardial infarction; (2) acute coronary syndrome due to acute atherothrombosis in a virally induced thrombotic and inflammatory milieu; (3) microvascular dysfunction due to diffuse microthrombi or vascular injury; (4) stress-related cardiomyopathy (Takotsubo syndrome); (5) nonischemic myocardial injury due to a hyperinflammatory cytokine storm; or (6) direct viral cardiomyocyte toxicity and myocarditis. Diffuse thrombosis is emerging as an important contributor to adverse outcomes in patients with COVID-19. Practitioners should be vigilant for cardiovascular complications of COVID-19. Monitoring may include serial cardiac troponin and natriuretic peptides, along with fibrinogen, D-dimer, and inflammatory biomarkers. Management decisions should rely on the clinical assessment for the probability of ongoing myocardial ischemia, as well as alternative nonischemic causes of injury, integrating the level of suspicion for COVID-19.


Assuntos
Betacoronavirus , Doenças Cardiovasculares/complicações , Infecções por Coronavirus/complicações , Pneumonia Viral/complicações , Monofosfato de Adenosina/análogos & derivados , Monofosfato de Adenosina/uso terapêutico , Alanina/análogos & derivados , Alanina/uso terapêutico , Antimaláricos/uso terapêutico , Antivirais/uso terapêutico , Betacoronavirus/imunologia , Betacoronavirus/patogenicidade , Biomarcadores/sangue , Cloroquina/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Humanos , Hidroxicloroquina/uso terapêutico , Hipóxia/complicações , Pandemias , Plasma/imunologia , Pneumonia Viral/tratamento farmacológico , Receptor Tipo 2 de Angiotensina/metabolismo , Fatores de Risco , Cardiomiopatia de Takotsubo/etiologia , Internalização do Vírus
20.
Emerg Infect Dis ; 26(10): 2484-2487, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32579877

RESUMO

We compared levels of severe acute respiratory syndrome coronavirus 2 neutralizing antibodies in recovery plasma from 7 completely asymptomatic coronavirus disease patients with those in symptomatic patients in South Korea. We found that serologic diagnostic testing was positive for 71% (5/7) of completely asymptomatic patients, but neutralizing antibody response occurred in all 7 patients.


Assuntos
Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Betacoronavirus/imunologia , Infecções por Coronavirus/sangue , Imunoglobulina G/sangue , Plasma/imunologia , Pneumonia Viral/sangue , Infecções Assintomáticas , Infecções por Coronavirus/diagnóstico , Humanos , Pandemias , Pneumonia Viral/diagnóstico , República da Coreia , Testes Sorológicos , Fatores de Tempo
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