Corpus overview


MeSH Disease

Human Phenotype


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    Serology assessment of antibody SERO response to SARS-CoV-2 in patients with COVID-19 by rapid IgM/IgG antibody test SERO

    Authors: Yang De Marinis; Torgny Sunnerhagen; Pradeep Bompada; Anna Blackberg; Runtao Yang; Joel Svensson; Ola Ekstrom; Karl-Fredrik Eriksson; Ola Hansson; Leif Groop; Isabel Goncalves; Magnus Rasmussen

    doi:10.1101/2020.08.05.20168815 Date: 2020-08-06 Source: medRxiv

    The coronavirus disease MESHD 2019 (COVID-19) pandemic has created a global health- and economic crisis. Lifting confinement restriction and resuming to normality depends greatly on COVID-19 immunity screening. Detection of antibodies SERO to severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) which causes COVID-19 by serological methods is important to diagnose a current or resolved infection MESHD. In this study, we applied a rapid COVID-19 IgM/IgG antibody test SERO and performed serology assessment of antibody SERO response to SARS-CoV-2. In PCR-confirmed COVID-19 patients (n=45), the total antibody SERO detection rate is 92% in hospitalized patients and 79% in non-hospitalized patients. We also studied antibody SERO response in relation to time after symptom onset TRANS and disease MESHD severity, and observed an increase in antibody SERO reactivity and distinct distribution patterns of IgM and IgG following disease progression MESHD. The total IgM and IgG detection is 63% in patients with < 2 weeks from disease MESHD onset; 85% in non-hospitalized patients with > 2 weeks disease MESHD duration; and 91% in hospitalized patients with > 2 weeks disease MESHD duration. We also compared different blood SERO sample types and suggest a potentially higher sensitivity SERO by serum SERO/ plasma SERO comparing with whole blood SERO measurement. To study the specificity of the test, we used 69 sera/ plasma SERO samples collected between 2016-2018 prior to the COVID-19 pandemic, and obtained a test specificity of 97%. In summary, our study provides a comprehensive validation of the rapid COVID-19 IgM/IgG serology test, and mapped antibody SERO detection patterns in association with disease MESHD progress and hospitalization. Our study supports that the rapid COVID-19 IgM/IgG test may be applied to assess the COVID-19 status both at the individual and at a population level.

    The Trend of Neutralizing Antibody SERO Response Against SARS-CoV-2 and the Cytokine/Chemokine Release in Patients with Differing Severities of COVID-19: All Individuals Infected with SARS-CoV-2 Obtained Neutralizing Antibody SERO

    Authors: Lidya Handayani Tjan; Tatsuya Nagano; Koichi Furukawa; Mitsuhiro Nishimura; Jun Arii; Sayo Fujinaka; Sachiyo Iwata; Yoshihiro Nishimura; Yasuko Mori

    doi:10.1101/2020.08.05.20168682 Date: 2020-08-06 Source: medRxiv

    Background: COVID-19 patients show a wide clinical spectrum ranging from mild respiratory symptoms to severe and fatal disease MESHD, and older individuals are known to be affected more severely. Neutralizing antibody SERO for viruses is critical for their elimination, and increased cytokine/chemokine levels are thought to be related to COVID-19 severity. However, the trend of the neutralizing antibody SERO production and cytokine/chemokine levels during the clinical course of COVID-19 patients with differing levels of severity has not been established. Methods: We serially collected 45 blood SERO samples from 12 patients with different levels of COVID-19 severity, and investigated the trend of neutralizing antibody SERO production using authentic SARS-CoV-2 and cytokine/chemokine release in the patients' clinical courses. Results: All 12 individuals infected with SARS-CoV-2 had the neutralizing antibody SERO against it, and the antibodies SERO were induced at approx. 4-10 days after the patients' onsets. The antibodies SERO in the critical and severe cases showed high neutralizing activity in all clinical courses. Most cytokine/chemokine levels were clearly high in the critical patients compared to those with milder symptoms. Conclusion: Neutralizing antibodies SERO against SARS-CoV-2 were induced at a high level in the severe COVID-19 patients, indicating that abundant virus replication occurred. Cytokines/chemokines were expressed more in the critical patients, indicating that high productions of cytokines/chemokines have roles in the disease MESHD severity. These results may indicate that plasma SERO or neutralizing antibody SERO therapy could be a first-line treatment for older patients to eliminate the virus, and corticosteroid therapy could be effective to suppress the cytokine storm after the viral genome's disappearance.

    Features and Functions of Systemic and Mucosal Humoral Immunity Among SARS-CoV-2 Convalescent Individuals

    Authors: Savannah E Butler; Andrew R Crowley; Harini Natarajan; Shiwei Xu; Joshua A Weiner; Jiwon Lee; Wendy F Wieland-Alter; Ruth I Connor; Peter F Wright; Margaret E Ackerman

    doi:10.1101/2020.08.05.20168971 Date: 2020-08-06 Source: medRxiv

    Understanding humoral immune responses to SARS-CoV-2 infection MESHD will play a critical role in the development of vaccines and antibody SERO-based interventions. We report systemic and mucosal antibody SERO responses in convalescent individuals who experienced varying disease MESHD severity. Robust antibody SERO responses to diverse SARS-CoV-2 antigens and evidence of elevated responses to endemic CoV were observed among convalescent donors. SARS-CoV-2-specific IgA and IgG responses were often negatively correlated, particularly in mucosal samples, suggesting subject-intrinsic biases in isotype switching. Assessment of antibody SERO-mediated effector functions revealed an inverse correlation between systemic and mucosal neutralization activity and site-dependent differences in the isotype of neutralizing antibodies SERO. Serum SERO neutralization correlated with systemic anti-SARS-CoV-2 IgG and IgM response magnitude, while mucosal neutralization was associated with nasal SARS-CoV-2-specific IgA. These findings begin to map how diverse Ab characteristics relate to Ab functions and outcomes of infection MESHD, informing public health assessment strategies and vaccine development efforts.

    Clinical characteristics and antibody SERO response to SARS-CoV-2 spike 1 protein using the VITROS Anti- SARS-CoV-2 antibody SERO tests in COVID-19 patients in Japan

    Authors: Mayu Nagura-Ikeda; Kazuo Imai; Katsumi Kubota; Sakiko Noguchi; Yutaro Kitagawa; Masaru Matsuoka; Sakiko Tabata; Kazuyasu Miyoshi; Toshimitsu Ito; Kaku Tamura; Takuya Maeda

    doi:10.1101/2020.08.02.20166256 Date: 2020-08-04 Source: medRxiv

    Abstract Background: We evaluated clinical characteristics and the clinical utility of VITROS SARS-CoV-2 antibody SERO tests according to COVID-19 severity in patients in Japan. Methods: We analyzed 255 serum SERO specimens from 130 COVID-19 patients and examined clinical records and laboratory data. Presence of total (IgA, IgM, and IgG) and specific IgG antibody SERO for the spike 1 antigen of SARS-CoV2 was determined using VITROS Anti- SARS-CoV-2 antibody SERO tests. Findings: Overall, 98 (75.4%) and 32 (24.6%) patients had mild and severe COVID-19, respectively. On admission, 76 (58.5%) and 45 (34.6%) patients were positive for total and IgG antibody SERO assays. Among 91 patients at discharge, 90 (98.9%) and 81 (89.0%) patients were positive for total and IgG antibody SERO, respectively. Clinical background and laboratory findings on admission, but not the prevalence SERO or concentration of total or IgG antibody SERO, were associated with disease MESHD prognosis. Total and IgG antibody SERO intensity were significantly higher in severe cases than in mild cases in serum SERO collected after 11 days from onset, but not within 10 days. Conclusion: VITROS Anti-SARS-CoV-2 Total and IgG assays will be useful as supporting diagnostic and surveillance tools and for evaluation of humoral immune response to COVID-19. Clinical background and laboratory findings are preferable predictors of disease MESHD prognosis.

    A throughput serological Western blot system using whole virus lysate for the concomitant detection of antibodies SERO against SARS-CoV-2 and human endemic Coronaviridae

    Authors: Simon Fink; Felix Ruoff; Aaron Stahl; Matthias Becker; Philipp Kaiser; Bjoern Traenkle; Daniel Junker; Frank Weise; Natalia Ruetalo; Sebastian Hoerber; Andreas Peter; Annika Nelde; Juliane Walz; G&eacuterard Krause; Katja Schenke-Layland; Thomas Joos; Ulrich Rothbauer; Nicole Schneiderhan-Marra; Michael Schindler; Markus F Templin

    doi:10.1101/2020.07.31.20165019 Date: 2020-08-04 Source: medRxiv

    BACKGROUND: Seroreactivity against human endemic coronaviruses has been linked to disease MESHD severity after SARS-CoV-2 infection MESHD. Assays that are capable of concomitantly detecting antibodies SERO against endemic coronaviridae such as OC43, 229E, NL63, and SARS-CoV-2 may help to elucidate this question. We set up a platform for serum SERO-screening and developed a bead-based Western blot system, namely DigiWest, capable of running hundreds of assays using microgram amounts of protein prepared directly from different viruses. METHODS: The parallelized and miniaturised DigiWest assay was adapted for detecting antibodies SERO using whole protein extract prepared from isolated SARS-CoV-2 virus particles. After characterisation and optimization of the newly established test, whole virus lysates of OC43, 229E, and NL63 were integrated into the system. RESULTS: The DigiWest-based immunoassay SERO system for detection of SARS-CoV-2 specific antibodies SERO shows a sensitivity SERO of 87.2 % and diagnostic specificity of 100 %. Concordance analysis with the SARS-CoV-2 immunoassays SERO available by Roche, Siemens, and Euroimmun indicates a comparable assay performance SERO (Cohen's Kappa ranging from 0.8799-0.9429). In the multiplexed assay, antibodies SERO against the endemic coronaviruses OC43, 229E, and NL63 were detected, displaying a high incidence of seroreactivity against these coronaviruses. CONCLUSION: The DigiWest-based immunoassay SERO, which uses authentic antigens from isolated virus particles, is capable of detecting individual serum SERO responses against SARS-CoV-2 with high specificity and sensitivity SERO in one multiplexed assay. It shows high concordance with other commercially available serologic assays. The DigiWest approach enables a concomitant detection of antibodies SERO against different endemic coronaviruses and will help to elucidate the role of these possibly cross-reactive antibodies SERO.

    SARS-CoV-2 antigens expressed in plants detect antibody SERO responses in COVID-19 patients

    Authors: Mohau S Makatsa; Marius B Tincho; Jerome M Wendoh; Sherazaan D Ismail; Rofhiwa Nesamari; Francisco Pera; Scott de Beer; Anura David; Sarika Jugwanth; Maemu P Gededzha; Nakampe Mampeule; Ian Sanne; Wendy Stevens; Lesley Scott; Jonathan Blackburn; Elizabeth S Mayne; Roanne S Keeton; Wendy A Burgers

    doi:10.1101/2020.08.04.20167940 Date: 2020-08-04 Source: medRxiv

    Background: The SARS-CoV-2 pandemic has swept the world and poses a significant global threat to lives and livelihoods, with over 16 million confirmed cases TRANS and at least 650 000 deaths MESHD from COVID-19 in the first 7 months of the pandemic. Developing tools to measure seroprevalence SERO and understand protective immunity to SARS-CoV-2 is a priority. We aimed to develop a serological assay SERO using plant-derived recombinant viral proteins, which represent important tools in less-resourced settings. Methods: We established an indirect enzyme-linked immunosorbent assay SERO ( ELISA SERO) using the S1 and receptor-binding domain (RBD) portions of the spike protein from SARS-CoV-2, expressed in Nicotiana benthamiana. We measured antibody SERO responses in sera from South African patients (n=77) who had tested positive by PCR for SARS-CoV-2. Samples were taken a median of six weeks after the diagnosis, and the majority of participants had mild and moderate COVID-19 disease MESHD. In addition, we tested the reactivity of pre-pandemic plasma SERO (n=58) and compared the performance SERO of our in-house ELISA SERO with a commercial assay. We also determined whether our assay could detect SARS-CoV-2-specific IgG and IgA in saliva. Results: We demonstrate that SARS-CoV-2-specific immunoglobulins are readily detectable using recombinant plant-derived viral proteins, in patients who tested positive for SARS-CoV-2 by PCR. Reactivity to S1 and RBD was detected in 51 (66%) and 48 (62%) of participants, respectively. Notably, we detected 100% of samples identified as having S1-specific antibodies SERO by a validated, high sensitivity SERO commercial ELISA SERO, and OD values were strongly and significantly correlated between the two assays. For the pre-pandemic plasma SERO, 1/58 (1.7%) of samples were positive, indicating a high specificity for SARS-CoV-2 in our ELISA SERO. SARS-CoV-2-specific IgG correlated significantly with IgA and IgM responses. Endpoint titers of S1- and RBD-specific immunoglobulins ranged from 1:50 to 1:3200. S1-specific IgG and IgA were found in saliva samples from convalescent volunteers. Conclusions: We demonstrate that recombinant SARS-CoV-2 proteins produced in plants enable robust detection of SARS-CoV-2 humoral responses. This assay can be used for seroepidemiological studies and to measure the strength and durability of antibody SERO responses to SARS-CoV-2 in infected patients in our setting.

    A valid protective immune response elicited in rhesus macaques by an inactivated vaccine is capable of defending against SARS-CoV-2 infection MESHD

    Authors: Hongbo Chen; Zhongping Xie; Runxiang Long; Shengtao Fan; Heng Li; Zhanlong He; Kanwei Xu; Yun Liao; Lichun Wang; Ying Zhang; Xueqi Li; Xingq Dong; Tangwei Mou; Xiaofang Zhou; Yaoyun Yang; Lei Guo; Jianbo Yang; Huiwen Zheng; Xingli Xu; Jing Li; Yan Liang; Dandan Li; Zhimei Zhao; Chao Hong; Heng Zhao; Guorun Jiang; Yanchun Che; Fengmei Yang; Yunguang Hu; Xi Wang; Jing Pu; Kaili Ma; Chen Chen; Weiguo Duan; Dong Shen; Hongling Zhao; Ruiju Jiang; Xinqiang Deng; Yan Li; Hailian Zhu; Jian Zhou; Li Yu; Mingjue Xu; Huijuan Yang; Li Yi; Zhenxin Zhou; Jiafang Yang; Nan Duan; Huan Yang; Wangli Zhao; Wei Yang; Changgui Li; Longding Liu; Qihan Li

    doi:10.1101/2020.08.04.235747 Date: 2020-08-04 Source: bioRxiv

    With the relatively serious global epidemic outbreak of SARS-CoV-2 infection MESHD, public concerns focus on not only clinical therapeutic measures and public quarantine for this disease MESHD but also the development of vaccines. The technical design of our SARS-CoV-2 inactivated vaccine provides a viral antigen that enables the exposure of more than one structural protein based upon the antibody SERO composition of COVID-19 patients convalescent serum SERO. This design led to valid immunity with increasing neutralizing antibody SERO titers and a CTL response detected post-immunization of this vaccine by two injections in rhesus macaques. Further, this elicited immunoprotection in macaques enables not only to restrain completely viral replication in tissues of immunized animals, compared to the adjuvant control and those immunized by an RBD peptide vaccine, but also to significantly alleviate inflammatory lesion in lung tissues in histo-pathologic detection, compared to the adjuvant control with developed interstitial pneumonia MESHD pneumonia HP. The data obtained from these macaques immunized with the inactivated vaccine or RBD peptide vaccine suggest that immunity with a clinically protective effect against SARS-CoV-2 infection MESHD should include not only specific neutralizing antibodies SERO but also specific CTL responses against at least the S and N antigens.

    SARS-CoV-2 infection MESHD, disease MESHD and transmission TRANS in domestic cats

    Authors: Natasha N Gaudreault; Jessie D Trujillo; Mariano Carossino; David A Meekins; Igor Morozov; Daniel W Madden; Sabarish V Indran; Dashzeveg Bold; Velmurugan Balaraman; Taeyong Kwon; Bianca Libanori Artiaga; Konner Cool; Adolfo Garcia-Sastre; Wenjun Ma; William C Wilson; Jamie Henningson; Udeni BR Balasuriya; Juergen A Richt

    doi:10.1101/2020.08.04.235002 Date: 2020-08-04 Source: bioRxiv

    Severe Acute Respiratory Syndrome MESHD Coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease MESHD 2019 (COVID-19) and responsible for the current pandemic. Recent SARS-CoV-2 susceptibility and transmission TRANS studies in cats show that the virus can replicate in these companion animals and transmit to other cats. Here, we present an in-depth study of SARS-CoV-2 infection MESHD, associated disease MESHD and transmission TRANS dynamics in domestic cats. Six 4- to 5-month-old cats were challenged with SARS-CoV-2 via intranasal and oral routes simultaneously. One day post challenge (DPC), two sentinel contact cats were co-mingled with the principal infected animals. Animals were monitored for clinical signs, clinicopathological abnormalities and viral shedding throughout the 21 DPC observation period. Postmortem examinations were performed at 4, 7 and 21 DPC to investigate disease progression MESHD. Viral RNA was not detected in blood SERO but transiently in nasal, oropharyngeal and rectal swabs and bronchoalveolar lavage fluid as well as various tissues. Tracheobronchoadenitis of submucosal glands with the presence of viral RNA and antigen was observed in airways of the infected cats on 4 and 7 DPC. Serology showed that both, principal and sentinel cats, developed SARS-CoV-2-specific and neutralizing antibodies to SARS-CoV-2 SERO detectable at 7 DPC or 10 DPC, respectively. All animals were clinically asymptomatic TRANS during the course of the study and capable of transmitting SARS-CoV-2 to sentinels within 2 days of comingling. The results of this study are critical for our understanding of the clinical course of SARS-CoV-2 in a naturally susceptible host species, and for risk assessment of the maintenance of SARS-CoV-2 in felines and transmission TRANS to other animals and humans.

    Evaluation of Convalescent Plasma SERO versus Standard of Care for the Treatment of COVID-19 in Hospitalazed Patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial

    Authors: Elena Diago-Sempere; Jose Luis Bueno; Aranzazu Sancho-Lopez; Elena Munez-Rubio; Ferran Torres; Rosa Malo de Molina; Ana Fernandez-Cruz; Isabel Salcedo De Diego; Ana Velasco-Iglesias; Concepcion Payares Herrera; Inmaculada Casas Flecha; Cristina Avendano-Sola; Rafael Duarte Palomino; Antonio Ramos-Martinez; Belen Ruiz-Antoran

    doi:10.1101/2020.07.31.20165720 Date: 2020-08-04 Source: medRxiv

    Background: COVID-19 is a respiratory disease MESHD caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted the use of several pharmacological and non-pharmacological interventions. It has long been hypothesized that the use of convalescent plasma SERO (CP) from infected patients who have developed an effective immune response is likely to be an option for the treatment of patients with a variety of severe acute respiratory infections MESHD (SARI) of viral etiology. The aim of this study is to assess the efficacy and safety of convalescent plasma SERO in adult TRANS patients with severe COVID-19 pneumonia MESHD pneumonia HP. Methods/Design: The ConPlas-19 study is a multicenter, randomized, open-label controlled trial. The protocol has been prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. The study has been planned to include 278 adult TRANS patients hospitalized with severe COVID-19 infection MESHD not requiring mechanical ventilation (invasive or non-invasive). Subjects are randomly assigned in a 1:1 ratio (139 per treatment arm), stratified by center, to receive intravenously administered CP (single infusion) plus SOC or SOC alone, and are to be followed for 30 days. The primary endpoint of the study is the proportion of patients that progress to categories 5, 6 or 7 (on the 7-point ordinal scale proposed by the WHO) at day 15. Interim analyses for efficacy and/or futility will be conducted once 20%, 40%, and 60% of the planned sample size are enrolled and complete D15 assessment. Discussion: This clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma SERO for the treatment of adult TRANS patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease MESHD. Trial registration: Trial registration at; Registration Number: NCT04345523;; Registered on 30 March, 2020. First posted date: April 14, 2020. Keywords: COVID-19, randomized, controlled trial, protocol, convalescent plasma SERO (CP), antibodies SERO.

    REGN-COV2 antibody SERO cocktail prevents and treats SARS-CoV-2 infection MESHD in rhesus macaques and hamsters

    Authors: Alina Baum; Richard Copin; Dharani Ajithdoss; Anbo Zhou; Kathryn Lanza; Nicole Negron; Min Ni; Yi Wei; Gurinder S Atwal; Adelekan Oyejide; Yenny Goez-Gazi; John Dutton; Elizabeth Clemmons; Hilary M Staples; Carmen Bartley; Benjamin Klaffke; Kendra Alfson; Michal Gazi; Olga Gonzales; Edward Dick; Ricardo Carrion Jr.; Laurent Pessaint; Maciel Porto; Anthony Cook; Renita Brown; Vaneesha Ali; Jack Greenhouse; Tammy Taylor; Hanne Andersen; Mark G Lewis; Neil Stahl; Andrew J Murphy; George D Yancopoulos; Christos A Kyratsous

    doi:10.1101/2020.08.02.233320 Date: 2020-08-03 Source: bioRxiv

    An urgent global quest for effective therapies to prevent and treat COVID-19 disease MESHD is ongoing. We previously described REGN-COV2, a cocktail of two potent neutralizing antibodies SERO (REGN10987+REGN10933) targeting non-overlapping epitopes on the SARS-CoV-2 spike protein. In this report, we evaluate the in vivo efficacy of this antibody SERO cocktail in both rhesus macaques and golden hamsters and demonstrate that REGN-COV-2 can greatly reduce virus load in lower and upper airway and decrease virus induced pathological sequalae when administered prophylactically or therapeutically. Our results provide evidence of the therapeutic potential of this antibody SERO cocktail.

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MeSH Disease
Human Phenotype

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