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1.
researchsquare; 2024.
Preprint en Inglés | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-3979076.v1

RESUMEN

Objective: This study aimed to investigate the prevalence and clinical manifestations of coronavirus disease (COVID-19) in patients with systemic lupus erythematosus (SLE) during the first wave of the pandemic in China and to evaluate the effects of COVID-19 on the disease activity and treatment of SLE.  Methods: A telephone survey was conducted on patients diagnosed with SLE in our hospital between October 2017 and October 2022. Through the survey, we investigated whether the patients had COVID-19, the clinical manifestations of the infection, whether the patients were vaccinated, the effects of the infection on the disease activity of SLE, and whether the treatment regimen for SLE was adjusted due to the infection.  Results: A total of 351 patients participated in this study, of whom 261 (74.4%) had COVID-19. Regarding organ involvement, the circulatory system was more commonly affected than the other organs in patients with SLE without COVID-19 (P = 0.002). Regarding concomitant medications, the daily dose of glucocorticoids was higher than that of other medication in SLE patients without COVID-19 (P = 0.000). No differences were observed in age, disease duration, disease activity, of other concomitant medications. While infected with COVID-19, 46 patients (17.6%) discontinued parts of their treatment without experiencing any episodes of SLE.  Conclusion: Most SLE patients with COVID-19 had a good prognosis, and all the patients in our study recovered from COVID-19 infection. Abrupt dose reduction and discontinuation of medications by the patients themselves may lead to elevated disease activity or even episodes of SLE. As such, it is recommended that the patients adjust their treatment regimens following the guidance of their specialists after careful evaluation of their condition and SLE disease activity by specialists.


Asunto(s)
COVID-19 , Hipercolesterolemia , Infecciones por Coronavirus , Lupus Eritematoso Sistémico
2.
biorxiv; 2023.
Preprint en Inglés | bioRxiv | ID: ppzbmed-10.1101.2023.04.19.537460

RESUMEN

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has evolved many high-risk variants, resulting in repeated COVID-19 waves of pandemic during the past years. Therefore, accurate early-warning of high-risk variants is vital for epidemic prevention and control. Here we construct a machine learning model to predict high-risk variants of SARS-CoV-2 by LightGBM algorithm based on several important haplotype network features. As demonstrated on a series of different retrospective testing datasets, our model achieves accurate prediction of all variants of concern (VOC) and most variants of interest (AUC=0.96). Prediction based on the latest sequences shows that the newly emerging lineage BA.5 has the highest risk score and spreads rapidly to become a major epidemic lineage in multiple countries, suggesting that BA.5 bears great potential to be a VOC. In sum, our machine learning model is capable to early predict high-risk variants soon after their emergence, thus greatly improving public health preparedness against the evolving virus.


Asunto(s)
Infecciones por Coronavirus , COVID-19
5.
Frontiers in public health ; 10, 2022.
Artículo en Inglés | EuropePMC | ID: covidwho-2147165

RESUMEN

Background A substantial reduction in the number of cardiac implantable electronic device (CIED) implantation was reported in the early stages of the COVID-19 pandemic. None of the studies have yet explored changes in CIED implantation during the following pandemic. Objective To explore changes in CIED implantation during the COVID-19 pandemic from 2020 to 2021. Methods From 2019 to 2021, 177,263 patients undergone CIED implantation from 1,227 hospitals in China were included in the analysis. Generalized linear models measured the differences in CIED implantation in different periods. The relationship between changes in CIED implantation and COVID-19 cases was assessed by simple linear regression models. Results Compared with the pre-COVID-19 period, the monthly CIED implantation decreased by 17.67% (95% CI: 16.62–18.72%, p < 0.001) in 2020. In 2021, the monthly number of CIED implantation increased by 15.60% (95% CI: 14.34–16.85%, p < 0.001) compared with 2020. For every 10-fold increase in the number of COVID-19 cases, the monthly number of pacemaker implantation decreased by 429 in 2021, while it decreased by 676 in 2020. The proportion of CIED implantation in secondary medical centers increased from 52.84% in 2019 to 56.77% in 2021 (p < 0.001). For every 10-fold increase in regional accumulated COVID-19 cases, the proportion of CIED implantation in secondary centers increased by 6.43% (95% CI: 0.47–12.39%, p = 0.036). Conclusion The impact of the COVID-19 pandemic on the number of CIED implantation is diminishing in China. Improving the ability of secondary medical centers to undertake more operations may be a critical way to relieve the strain on healthcare resources during the epidemic.

6.
Frontiers in public health ; 10, 2022.
Artículo en Inglés | EuropePMC | ID: covidwho-2034136

RESUMEN

Housing safety and health problems threaten owners' and occupiers' safety and health. Nevertheless, there is no systematic review on this topic to the best of our knowledge. This study compared the academic and public opinions on housing safety and health and reviewed 982 research articles and 3,173 author works on housing safety and health published in the Web of Science Core Collection. PRISMA was used to filter the data, and natural language processing (NLP) was used to analyze emotions of the s. Only 16 housing safety and health articles existed worldwide before 1998 but increased afterward. U.S. scholars published most research articles (30.76%). All top 10 most productive countries were developed countries, except China, which ranked second (16.01%). Only 25.9% of institutions have inter-institutional cooperation, and collaborators from the same institution produce most work. This study found that most s were positive (n = 521), but s with negative emotions attracted more citations. Despite many industries moving toward AI, housing safety and health research are exceptions as per articles published and Tweets. On the other hand, this study reviewed 8,257 Tweets to compare the focus of the public to academia. There were substantially more housing/residential safety (n = 8198) Tweets than housing health Tweets (n = 59), which is the opposite of academic research. Most Tweets about housing/residential safety were from the United Kingdom or Canada, while housing health hazards were from India. The main concern about housing safety per Twitter includes finance, people, and threats to housing safety. By contrast, people mainly concerned about costs of housing health issues, COVID, and air quality. In addition, most housing safety Tweets were neutral but positive dominated residential safety and health Tweets.

7.
Computers in biology and medicine ; 2022.
Artículo en Inglés | EuropePMC | ID: covidwho-2027063

RESUMEN

Despite global vaccination efforts, COVID-19 breakthrough infections caused by variant virus continue to occur frequently, long-term sequelae of COVID-19 infection like neuronal dysfunction emerge as a noteworthy issue. Neuroimmune disorder induced by Inflammatory factor storm was considered as a possible reason, however, little was known about the functional factors affecting neuroimmune response to this virus. Here, using medial prefrontal cortex single cell data of COVID-19 patients, expression pattern analysis indicated that some immune-related pathway genes expressed specifically, including genes associated with T cell receptor, TNF signaling in microglia and Cytokine-cytokine receptor interaction and HIF-1 signaling pathway genes in astrocytes. Besides the well-known immune-related cell type microglia, we also observed immune-related factors like IL17D, TNFRSF1A and TLR4 expressed in Astrocytes. Based on the ligand-receptor relationship of immune-related factors, crosstalk landscape among cell clusters were analyzed. The findings indicated that astrocytes collaborated with microglia and affect excitatory neurons, participating in the process of immune response and neuronal dysfunction. Moreover, subset of astrocytes specific immune factors (hinged neuroimmune genes) were proved to correlate with Covid-19 infection and ventilator-associated pneumonia using multi-tissue RNA-seq and scRNA-seq data. Function characterization clarified that hinged neuroimmune genes were involved in activation of inflammation and hypoxia signaling pathways, which could lead to hyper-responses related neurological sequelae. Finally, a risk model was constructed and testified in RNA-seq and scRNA data of peripheral blood.

8.
Virus evolution ; 2022.
Artículo en Inglés | EuropePMC | ID: covidwho-1998565

RESUMEN

Phylogenetic analysis has been widely used to describe, display and infer the evolutionary patterns of viruses. The unprecedented accumulation of SARS-CoV-2 genomes has provided valuable materials for the real-time study of SARS-CoV-2 evolution. However, the large number of SARS-CoV-2 genome sequences also poses great challenges for data analysis. Several methods for subsampling these large data sets have been introduced. However, current methods mainly focus on the spatiotemporal distribution of genomes without considering their genetic diversity, which might lead to postsubsampling bias. In this study, a subsampling method named covSampler was developed for the subsampling of SARS-CoV-2 genomes with consideration of both their spatiotemporal distribution and their genetic diversity. First, covSampler clusters all genomes according to their spatiotemporal distribution and genetic variation into groups that we call divergent pathways. Then, based on these divergent pathways, two kinds of subsampling strategies, representative subsampling and comprehensive subsampling, were provided with adjustable parameters to meet different users’ requirements. Our performance and validation tests indicate that covSampler is efficient and stable, with an abundance of options for user customization. Overall, our work has developed an easy-to-use tool and a webserver (https://www.covsampler.net) for the subsampling of SARS-CoV-2 genome sequences.

9.
Frontiers in psychology ; 13, 2022.
Artículo en Inglés | EuropePMC | ID: covidwho-1940335

RESUMEN

Background Cyberchondria has been brought into sharp focus during the COVID-19 health emergency;it refers to individuals who obsessively and compulsively search for health information online, resulting in excessive health concerns. Recent scholarship focuses on its obsessive and compulsive aspect, following a biopsychosocial approach as opposed to a pathology of health anxiety. It lacks interpretation of the socio-psychological dynamics between the dimensions. Objective This review aims to propose a holistic view toward understanding cyberchondria as an obsessive–compulsive syndrome and considers possible interventions. It specifically seeks to explain cyberchondria from diversified mediator variables and to pinpoint connections between each perspective. Methodology Comprehensive searches of databases such as PubMed and Springer were conducted to identify English articles relating to cyberchondria from 2001 to 2022. Based on a systematic filtering process, 27 articles were finally reviewed. Findings The authors compare and confirm three forecasts to predict cyberchondria, associating it with individual metacognition, uncertainty of unverified information, and algorithm-driven, biased information environments. Value Theoretically, a holistic framework is proposed to explain the obsessive and compulsive features of cyberchondria. Clinically, the research calls for more professional psychoeducation and chain screening of cyberchondria and other psychological disorders. Socially, it promotes support for risk-sensitive, information-deficient groups during pandemics like COVID-19. It also stresses more careful use of algorithm-driven search engine technology for platforms delivering medical information. Future research may explore areas such as the association between cyberchondria and other social-related disorders, as well as correlations among cyberchondria, obsessive and compulsive disorders, medical trust, and algorithm-driven search results.

10.
biorxiv; 2022.
Preprint en Inglés | bioRxiv | ID: ppzbmed-10.1101.2022.07.23.501111

RESUMEN

Haplotype network is becoming popular due to its increasing use in analyzing genealogical relationships of closely related genomes. We newly proposed McAN, a minimum-cost arborescence based haplotype network con-struction algorithm, by considering mutation spectrum history (mutations in ancestry haplotype should be contained in descendant haplotype), node size (corresponding to sample count for a given node) and sampling time. McAN is two orders of magnitude faster than the state-of-the-art algorithms, making it suitable for analyzation of massive se-quences. Availability: Source code is written in C/C++ and available at https://github.com/Theory-Lun/McAN and https://ngdc.cncb.ac.cn/biocode/tools/BT007301 under the MIT license. The online web service of McAN is available at https://ngdc.cncb.ac.cn/ncov/online/tool/haplotype. SARS-CoV-2 dataset are available at https://ngdc.cncb.ac.cn/ncov/.

11.
medrxiv; 2022.
Preprint en Inglés | medRxiv | ID: ppzbmed-10.1101.2022.07.19.22277248

RESUMEN

Background: There is a lack of studies on large-sample, medium-, or long-term follow-up data of peripheral neuropathy (PNP) in the COVID-19 survivors. This study evaluated the characteristics and related risk factors of PNP in the medium- and long-term rehabilitation,which provided real-world study data for the complete recovery of COVID-19 patients. Methods: This study was a prospective cohort study of the COVID-19 survivors. We collected data on baseline characteristics, symptoms at onset and after discharge during the 6-month and 12-month follow-up. Peripheral nerves were measured by electromyography and inducible potentiometer. We used multivariable logistic regression to analyze the influencing factors of PNP. Additionally, we compared the difference between the two measurements among the population who completed both measurements. Results: 313 patients were included in the study and all of them underwent nerve conduction study. 67 patients completed two measurements at 6-month and 12-month follow-up. Commonly reported symptoms contained memory loss (86%), hair loss (28%), anxiety (24%), and sleep difficulties (24%). 232 patients (74%) were found with PNP, including 51 (16%) with mononeuropathy and 181 (58%) with generalized PNP. Patients with measurement at 12-month follow-up had a higher prevalence of generalized PNP (p=0.006). For pathological types, 64 (20%) patients had only axonal loss, 67 (21%) had only demyelination, and 101 (32%) had a mixed type. There was no significant difference in the prevalence of accompanying symptoms after discharge between the two groups with or without PNP. After adjustment, age was positively associated with PNP (OR=1.22 per 10-year increase of age, 95% CI, 1.05-1.41). Compared with less than the median amount of IgG at discharge, higher amount of IgG was associated with decreased risk of F-wave abnormality (OR=0.32, 95%CI, 0.11-0.82), but no significant difference in other types of PNP. Conclusions and Relevance: SARS-CoV-2 could cause PNP in hospital survivors with COVID-19, which persisted and was associated with age, education, and IgG antibody at discharge, but had no significant correlation with symptoms after discharge.


Asunto(s)
Trastornos de la Memoria , Trastornos de Ansiedad , Mononeuropatías , Enfermedades del Sistema Nervioso Periférico , COVID-19 , Enfermedades Desmielinizantes , Enfermedades de los Ganglios Basales
13.
biorxiv; 2022.
Preprint en Inglés | bioRxiv | ID: ppzbmed-10.1101.2022.05.12.491597

RESUMEN

mRNA vaccines have emerged as a most promising and potent platform in the fight against various diseases including the COVID-19 pandemic. However, the intrinsic instability, varying side effects associated with the delivery systems, and continuous emergence of virus variants highlight the urgent need for the development of stable, safe and efficacious mRNA vaccines. In this study, by screening a panel of proprietary biodegradable ionizable lipidoids, we reported on a novel mRNA vaccine (cmRNA-1130) formed from a biodegradable lipidoid with eight ester bonds in the branched tail (AX4) and synthetic circular mRNA (cmRNA) encoding the trimeric Delta receptor binding domain (RBD) of SARS-CoV-2 spike protein for the induction of robust immune activation. The AX4-based lipid nanoparticles (AX4-LNP) revealed much faster elimination rate from liver and spleen in comparison with commercialized MC3-based LNP (MC3-LNP) and afforded normal level of alanine transferase (ALT), aspartate aminotransferase (AST), and creatinine (CRE) in BALB/c mice. Following intramuscular (IM) administration in BALB/c mice, cmRNA-1130 elicited potent and sustained neutralizing antibodies, RBD-specific CD4+ and CD8+ T effector memory cells (Tem), and Th1-biased T cell activations. cmRNA-1130 vaccine showed excellent stability against 6-month storage at 4 {degrees}C and freezing-thawing cycles. In brief, our study highlights mRNA vaccines based on cmRNA and biodegradable AX4 lipids hold great potential as superb therapeutic platforms for the treatment of varying diseases.


Asunto(s)
COVID-19
14.
researchsquare; 2022.
Preprint en Inglés | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-1608327.v2

RESUMEN

In this study, we aimed to explore whether Lymphocyte-C-reactive protein ratio (LCR) can differentiate disease severity of Coronavirus disease 2019 (COVID-19) patients and its value as an assistant screening tool for admission to the hospital and the intensive care unit (ICU). A total of 184 adult COVID-19 patients from the COVID-19 Treatment Center in Heilongjiang Province at the First Affiliated Hospital of Harbin Medical University between January 2020 and March 2021 were included in this study. Patients were divided into asymptomatic infection group, mild group, moderate group, severe group, and critical group according to the Diagnosis and Treatment of New Coronavirus Pneumonia (9th edition). Demographic and clinical data including gender, age, comorbidities, severity of COVID-19, white blood cell count (WBC), neutrophil proportion (NEUT%), lymphocyte count (LYMPH), lymphocyte percentage (LYM%), red blood cell distribution width (RDW), platelet (PLT), C-reaction protein (CRP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (SCr), albumin (ALB), total bilirubin (TB), direct bilirubin (DBIL), indirect bilirubin (IBIL), and D-Dimer were obtained and collated from medical records at admission, from which sequential organ failure assessment (SOFA) score and LCR were calculated, and all above indicators were compared among groups. Multiple clinical parameters, including LYMPH, CRP and LCR, showed significant differences among groups. The related factors to classify COVID-19 patients into moderate, severe and critical groups included age, number of comorbidities, WBC, LCR, and AST. Among these factors, number of comorbidities showed the greatest effect, and only WBC and LCR were protective factors. The area under the receiver operating characteristic (ROC) curve of LCR to classify COVID-19 patients into moderate, severe and critical groups was 0.176. The cut-off value of LCR, and the sensitivity and specificity of ROC curve were 1780.7050, 84.6% and 66.2%, respectively. The related factors to classify COVID-19 patients into severe and critical groups included number of comorbidities, PLT, LCR, and SOFA score. Among these factors, SOFA score showed the greatest effect, and LCR was the only protective factor. The area under ROC curve of LCR to classify COVID-19 patients into severe and critical groups was 0.106. The cut-off value of LCR and the sensitivity and specificity of ROC curve were 571.2200, 81.3% and 90.0%, respectively. In summary, LCR can differentiate disease severity of COVID-19 patients and serve as a simple and objective assistant screening tool for hospital and ICU admission.


Asunto(s)
COVID-19
15.
researchsquare; 2022.
Preprint en Inglés | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-1423306.v1

RESUMEN

Purpose To investigate the impact of COVID-19 on the treatment of children with congenital diaphragmatic hernia (CDH).Methods We retrospectively collected and compared the data of patients with CDH admitted between January 1, 2020 and December 31, 2021 with the CDH patients admitted before the pandemic between January 1, 2018 and December 31, 2019 (control group).Results During the pandemic, 41 patients with CDH diagnosed prenatally were transferred to our hospital, and 40 underwent surgical repair. The number of patients treated in our hospital increased by 24.2% compared with that before the pandemic. During the pandemic, the overall survival rate, postoperative survival rate and recurrence rate were 85.4%, 87.5% and 7.3%, respectively, and there were no significant differences compared with the control group. The average length of hospital stay in patients admitted during the pandemic was longer than that in the control group, and the incidence of nosocomial infection was higher than that in the control group.Conclusions CDH patients confirmed to be SARS-CoV-2 infection-free can receive routine treatment. Our data indicate that the implementation of protective measures during the COVID-19 pandemic, along with appropriate screening and case evaluation, do not have a negative impact on the prognosis of children.


Asunto(s)
COVID-19
16.
researchsquare; 2022.
Preprint en Inglés | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-1406060.v1

RESUMEN

Purpose: The immunogenicity of SARS-CoV-2 vaccines is poor in kidney transplant recipients (KTRs). The factors related to poor immunogenicity to vaccination in KTRs are not well defined. Methods An observational study was conducted in KTRs and healthy individuals who had received two doses of SARS-CoV-2 inactivated vaccine. IgG antibodies against the receptor-binding domain found in the S1 subunit of the spike protein, and against nucleocapsid protein were measured using enzyme-linked immunosorbent assay. Receptor-binding domain (RBD)-angiotensin-converting enzyme 2 interaction-blocking antibodies were measured using commercial kits. T cell responses against the spike and nucleocapsid proteins were detected using enzyme-linked immunosorbent spot assay. Results No severe adverse effects were observed in KTRs after first or second dose of SARS-CoV-2 inactivated vaccine. IgG antibodies against the receptor- binding domain, and nucleocapsid protein were not effectively induced in a majority of KTRs after second dose of inactivated vaccine. Specific T cell immunity response was detectable in 32%-40% KTRs after second doses of inactivated vaccine. KTRs who developed specific T cell immunity were more likely to be female, and have lower levels of total bilirubin, unconjugated bilirubin, and blood tacrolimus concentration. Multivariate logistic regression analysis found that blood unconjugated bilirubin was significantly negatively associated with SARS-CoV-2 specific T cell immunity response in k KTRs. Conclusions Specific T cell immunity response could be induced in 32%-40% KTRs after two doses of inactivated vaccine. Blood unconjugated bilirubin was negatively associated with specific cellular immunity response in KTRs following vaccination.

17.
biorxiv; 2021.
Preprint en Inglés | bioRxiv | ID: ppzbmed-10.1101.2021.11.01.466725

RESUMEN

The application of mRNA as a novel kind of vaccine has been proved recently, due to the emergence use authorization (EUA) by FDA for the two COVID-19 mRNA vaccines developed by Moderna and BioNTech. Both of the two vaccines are based on canonical linear mRNA, and encapsulated by lipid nanoparticle (LNP). Circular mRNA, which is found to mediate potent and durable protein expression, is an emerging technology recently. Owing to its simplicity of manufacturing and superior performance of protein expression, circular mRNA is believed to be a disruptor for mRNA area. However, the application of circular mRNA is still at an initiation stage, proof of concept for its usage as future medicine or vaccine is necessary. In the current study, we established a novel kind of circular mRNA, termed C-RNA, based on Echovirus 29 (E29)-derived internal ribosome entry sites (IRES) and newly designed homology arms and RNA spacers. Our results demonstrated that this kind of circular mRNA is able to mediate strong and durable protein expression, compared to typical linear mRNA. Moreover, for the first time, our study demonstrated that direct intratumoral administration of C-RNA encoding a mixture of cytokines achieved successful modulation of intratumoral and systematic anti-tumor immune responses and finally leading to an enhancement of anti-PD-1 antibody-induced tumor repression in syngeneic mouse model. Additionally, after an optimization of the circular mRNA formulation, a significant improvement of C-RNA mediated protein expression was observed. With this optimized formulation, C-RNA induced enhanced anti-tumor effect via intratumoral administration and elicited significant activation of tumor-infiltrated total T cells and CD8 + T cells. Collectively, we established C-RNA, a novel circular mRNA platform, and demonstrated that it can be applied for direct intratumoral administration for cancer therapy.


Asunto(s)
COVID-19 , Neoplasias
18.
Textile Research Journal ; : 00405175211053397, 2021.
Artículo en Inglés | Sage | ID: covidwho-1480332

RESUMEN

To achieve efficient and environmental reuse of waste ribbons, artworks reconstructed from waste ribbons for decorative occasions were inspired by the dedicated and determined people working against coronavirus disease 2019 (COVID-19) and developed through a handmade and delicate strategy. With the theme of ?Ordinary * Extraordinary,? the artworks aim to convey endless positive energy and hope to people suffering from COVID-19. To fulfill the art reconstruction, the design idea, composition design and color design were comprehensively considered and carefully described. The artworks were applied for decoration in hospital wards and the home environment. Their composition and color gave medical workers, patients and ordinary people suffering from COVID-19 a sense of comfort and warmth. All positive energy from our artworks accompanied people and encouraged them never to give up and overcome COVID-19. The art reconstruction of waste ribbons proposed in this study may provide an excellent way for the reuse of waste ribbons. More importantly, it improves the added value of products and strengthens people's determination to overcome COVID-19.

19.
《国际护理与健康》 ; 2021.
Artículo en Chino | Omniscient | ID: covidwho-1411127

RESUMEN

Abstract: Objective: To investigate the self-examination physiological health level of medical staffs under the tertiary protection, and analyze the physiological health problems and influencing factors of the medical staffs under the three-level protection. Methods: from March 19, 2020 to April 3, 2020, using snowball sampling method, a total of 103 anti epidemic medical staffs from two top three hospitals in Guangdong Province were invited to conduct a network questionnaire survey. Results: a total of 102 valid online questionnaires were analyzed. The results showed that the health status and organ function of medical staffs were 6.37% ± 77, daily life function was 10. 19 ± 63 and 9. 97 respectively ± 22 points, all above the middle level;The analysis showed that the self-examination physiological health level was affected by the gender of medical staffs, whether drinking, health status and intuitive feelings under three-level protection. Conclusion: the self-examination physiological health of medical staffs under the three-level protection is in the upper middle level, so we should pay more attention to and support the physiological health of medical staffs under the three-level protection.

20.
medrxiv; 2021.
Preprint en Inglés | medRxiv | ID: ppzbmed-10.1101.2021.06.29.21259427

RESUMEN

The efficacy of convalescent plasma for COVID-19 is unclear. While most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content may influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 days of respiratory symptom onset. Patients were allocated 2:1 to 500 mL of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 days. The effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. 940 patients were randomized and 921 patients were included in the intent-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) in the convalescent plasma arm and 86/307 (28.0%) in the standard of care arm; relative risk (RR) 1.16 (95% confidence interval (CI) 0.94-1.43; p=0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% vs. 26.4%; RR=1.27, 95% CI 1.02-1.57, p=0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standard log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (OR=0.74; 0.57-0.95 and OR=0.66; 0.50-0.87, respectively), while IgG against the full transmembrane Spike protein increased it (OR=1.53, 95% CI 1.14-2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 days among hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavourable antibody profiles may be associated with worse clinical outcomes compared to standard care.


Asunto(s)
COVID-19 , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Muerte
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