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1.
Intern Med ; 2022 Nov 23.
Article in English | MEDLINE | ID: covidwho-2141176

ABSTRACT

A 19-year-old Japanese man was hospitalized for cardiogenic shock 28 days after receiving a second dose of the COVID-19 mRNA-1273 vaccine. He had had a high fever for three days with vomiting and abdominal pain before arriving at our hospital. The patient visited a local hospital and was diagnosed with heart failure and acute appendicitis. An endomyocardial biopsy specimen showed myocarditis. Thereafter, Impella CP left ventricular assist device implantation and venoarterial peripheral extracorporeal membranous oxygenation were initiated immediately along with inotropic support and steroid pulse therapy. Given these findings, he was finally diagnosed with multiple inflammatory syndrome and fulminant myocarditis.

2.
Virol J ; 19(1): 188, 2022 11 16.
Article in English | MEDLINE | ID: covidwho-2117139

ABSTRACT

INTRODUCTION: We investigated the performance of the cobas® 6800 system and cobas SARS-CoV-2 & Influenza A/B, a fully automated molecular testing system for influenza viruses and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This enabled an assay in a batch of 96 samples in approximately 3 h. METHODS: An assay was performed using the cobas SARS-CoV-2 & Influenza A/B on the cobas 6800 system for samples collected in four facilities between November 2019 and March 2020 in our previous study. The results were compared with those obtained using the reference methods. RESULTS: Of the 127 samples analyzed, the cobas SARS-CoV-2 & Influenza A/B detected influenza A virus in 75 samples, of which 73 were positive using the reference methods. No false negative results were observed. The overall positive and negative percent agreement for influenza A virus detection were 100.0% and 96.3%, respectively. There were no positive results for the influenza B virus or SARS-CoV-2. CONCLUSION: The cobas 6800 system and cobas SARS-CoV-2 & Influenza A/B showed high accuracy for influenza A virus detection and can be useful for clinical laboratories, especially those that routinely assay many samples.


Subject(s)
COVID-19 , Influenza, Human , Orthomyxoviridae , Humans , Influenza, Human/diagnosis , SARS-CoV-2/genetics , Molecular Diagnostic Techniques
3.
J Clin Med ; 11(18)2022 Sep 16.
Article in English | MEDLINE | ID: covidwho-2043801

ABSTRACT

Managing mild illness in COVID-19 and predicting progression to severe disease are concerning issues. Here, we investigated the outcomes of Japanese patients with mild COVID-19, and identified triage risk factors for further hospitalization and emergency department (ED) visits at a single tertiary hospital. A triage checklist with 30 factors was used. Patients recommended for isolation were followed up for 10 days for subsequent ED visits or hospital admission. Overall, 338 patients (median age, 44.0; 45% women) visited the clinic 5.0 days (median) after symptom onset. Thirty-six patients were immediately hospitalized following triage; others were isolated. In total, 72 non-hospitalized patients visited the ED during their isolation, and 30 were hospitalized after evaluation for oxygen desaturation. The median ED visit and hospitalization durations after symptom onset were 5.0 and 8.0 days, respectively. The checklist factors associated with hospitalization during isolation were age > 50 years, body mass index > 25 kg/m2, hypertension, tachycardia with pulse rate > 100/min or blood pressure > 135 mmHg at triage, and >3-day delay in hospital visit after symptom onset. No patients died. Altogether, 80% of patients with mild COVID-19 could be safely isolated at home. Age, BMI, underlying hypertension, date after symptom onset, tachycardia, and systolic blood pressure at triage might be related to later hospitalization.

4.
BMJ Open ; 12(9): e061172, 2022 09 14.
Article in English | MEDLINE | ID: covidwho-2029502

ABSTRACT

INTRODUCTION: The COVID-19 pandemic has been a major concern worldwide; however, easily accessible treatment options for patients with mild COVID-19 remain limited. Since the oral intake of Lactococcus lactis strain plasma (LC-Plasma) enhances both the innate and acquired immune systems through the activation of plasmacytoid dendritic cells (pDCs), we hypothesised that the oral intake of LC-Plasma could aid the relief or prevention of symptoms in patients with asymptomatic or mild COVID-19. METHODS AND ANALYSIS: This is an exploratory, multicentre, double-blinded, randomised, placebo-controlled trial. This study was initiated in December 2021 and concludes in April 2023. The planned number of enrolled subjects is 100 (50 subjects×2 groups); subject enrolment will be conducted until October 2022. Patients with asymptomatic or mild COVID-19 will be enrolled and randomly assigned in a 1:1 ratio to group A (oral intake of LC-Plasma-containing capsule, 200 mg/day, for 14 days) or group B (oral intake of placebo capsule, for 14 days). The primary endpoint is the change in subjective symptoms measured by the severity score. Secondary endpoints include SARS-CoV-2 viral loads, biomarkers for pDC activation, serum SARS-CoV-2-specific antibodies, serum cytokines, interferon and interferon-inducible antiviral effectors and the proportion of subjects with emergency room visits to medical institutions or who are hospitalised. ETHICS AND DISSEMINATION: The study protocol was approved by the Clinical Research Review Board of Nagasaki University, in accordance with the Clinical Trials Act of Japan. The study will be conducted in accordance with the Declaration of Helsinki, the Clinical Trials Act, and other current legal regulations in Japan. Written informed consent will be obtained from all the participants. The results of this study will be reported in journal publications. TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials (registration number: jRCTs071210097).


Subject(s)
COVID-19 , Lactococcus lactis , Humans , Interferons , Lactococcus lactis/physiology , Multicenter Studies as Topic , Pandemics , Randomized Controlled Trials as Topic , SARS-CoV-2
5.
Intern Med ; 61(15): 2319-2325, 2022 Aug 01.
Article in English | MEDLINE | ID: covidwho-1974464

ABSTRACT

A 60-year-old Japanese woman was hospitalized for cardiogenic shock 24 days after receiving the second dose of the coronavirus disease 2019 BNT162b2 vaccine. Impella CP left ventricular assist device implantation and venoarterial peripheral extracorporeal membranous oxygenation were immediately initiated along with inotropic support and steroid pulse therapy, as an endomyocardial biopsy specimen showed myocarditis. Three weeks later, her cardiac function had recovered, and she was discharged. An immune response associated with the presence of spike protein in cardiac myocytes may be related to myocarditis in the present case because of positive immunostaining for severe acute respiratory syndrome coronavirus 2 spike protein and C4d in the myocardium.


Subject(s)
BNT162 Vaccine , COVID-19 , Coronavirus , Heart-Assist Devices , Myocarditis , BNT162 Vaccine/adverse effects , COVID-19/complications , Female , Heart-Assist Devices/adverse effects , Humans , Middle Aged , Myocarditis/complications , RNA/therapeutic use , Shock, Cardiogenic/etiology , Spike Glycoprotein, Coronavirus
6.
J Infect Chemother ; 28(7): 955-961, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1783495

ABSTRACT

INTRODUCTION: Nursing facilities are vulnerable to coronavirus disease 2019 (COVID-19) due to the congregate nature of their housing, the older age of the residents, and the variety of their geriatric chronic conditions. Little is known about the impact of nursing facility COVID-19 on the local health system. METHODS: We collected data of COVID-19 cases in Nagasaki city from April 15, 2020 to June 30, 2021. We performed universal screening of the healthcare workers (HCWs) and the users of nursing facilities, once the first case of COVID-19 was detected within that facility. The community-dwelling people received testing if they had symptoms or if they were suspected of having close contact with the positive cases. The epidemiological survey for each COVID-19 case was performed by the public health officers of the local public health center. RESULTS: Out of 111,773 community-dwelling older adults (age ≥ 65 years) and 20,668 nursing facility users in Nagasaki city, we identified 358 and 71 COVID-19 cases, and 33 and 12 COVID-19 deaths, respectively, during the study period. The incidence rate ratios (IRRs) for COVID-19 and its deaths among the nursing facility users were 1.07 (95% confidence interval (CI), 0.82-1.39) and 1.97 (95%CI, 0.92-3.91) compared with the community-dwelling older adults. Four clusters, which had more than 10 COVID-19 cases, accounted for 60% (65/109) of the overall cases by the HCWs and the users. CONCLUSIONS: The prevention of COVID-19 clusters is important to reduce the number of COVID-19 cases and deaths among the nursing facility population.


Subject(s)
COVID-19 , Aged , COVID-19/epidemiology , COVID-19 Testing , Health Personnel , Humans , Japan/epidemiology , SARS-CoV-2
7.
Microorganisms ; 10(1)2022 Jan 04.
Article in English | MEDLINE | ID: covidwho-1613908

ABSTRACT

In the initial phase of the novel coronavirus disease (COVID-19) pandemic, a large-scale cluster on the cruise ship Diamond Princess (DP) emerged in Japan. Genetic analysis of the DP strains has provided important information for elucidating the possible transmission process of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on a cruise ship. However, genome-based analyses of SARS-CoV-2 detected in large-scale cruise ship clusters other than the DP cluster have rarely been reported. In the present study, whole-genome sequences of 94 SARS-CoV-2 strains detected in the second large cruise ship cluster, which emerged on the Costa Atlantica (CA) in Japan, were characterized to understand the evolution of the virus in a crowded and confined place. Phylogenetic and haplotype network analysis indicated that the CA strains were derived from a common ancestral strain introduced on the CA cruise ship and spread in a superspreading event-like manner, resulting in several mutations that might have affected viral characteristics, including the P681H substitution in the spike protein. Moreover, there were significant genetic distances between CA strains and other strains isolated in different environments, such as cities under lockdown. These results provide new insights into the unique evolution patterns of SARS-CoV-2 in the CA cruise ship cluster.

8.
Front Med (Lausanne) ; 8: 785409, 2021.
Article in English | MEDLINE | ID: covidwho-1603084

ABSTRACT

Acute respiratory distress syndrome (ARDS) is characterized by dysregulated vascular permeability. The clinical outcomes remain poor, and the disease burden is widespread. We demonstrated that plasma 5-hydroxyindoleacetic acid (5-HIAA), a serotonin metabolite, is a pivotal severity indicator of ARDS. Serotonin is an effector of cellular contraction and a modulator of vascular permeability. Plasma 5-HIAA levels were significantly elevated in severe ARDS cases with shock status (p = 0.047) and positively correlated with SOFA (p < 0.0001) and APACHE-II score (p < 0.0001). In the longitudinal analysis, plasma 5-HIAA levels were also a strong independent predictor of mortality rate (p = 0.005). This study indicates that plasma 5-HIAA is a biomarker of ARDS severity and highlights the importance of evaluating vascular leakage levels for ARDS treatment.

12.
ERJ Open Res ; 7(4)2021 Oct.
Article in English | MEDLINE | ID: covidwho-1496133

ABSTRACT

An online nationwide questionnaire survey in Japan revealed that the incidence rate of #COVID19 associated pulmonary aspergillosis in critical COVID-19 cases was extremely low (0.54%) compared with those previously reported in the USA and Europe https://bit.ly/2WdFtPj.

14.
Respir Investig ; 60(1): 154-157, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1458829

ABSTRACT

An internet questionnaire survey for investigating empirical antibiotic usage and bacterial superinfections in patients with coronavirus disease-2019 (COVID-19) in Japan was conducted among the chief physicians of respiratory disease departments of 715 Japanese Respiratory Society-certified hospitals using Google Forms between January 28, 2021 and February 28, 2021. Responses to the questionnaire survey were obtained from 198 of 715 hospitals (27.6%). The survey revealed that the complication incidences of community-acquired pneumonia; hospital-acquired pneumonia, including ventilator-associated pneumonia; and sepsis were 2.86, 5.59, and 0.99%, respectively, among patients with moderate/severe and critical COVID-19. Bacterial co-infection and secondary infection rarely affected patients with COVID-19 in Japan, and the isolated pathogens were not specific to these patients. Moreover, the anti-inflammatory effects of macrolides for COVID-19 were not observed in several studies. These results might be useful in clinical practice for COVID-19.


Subject(s)
COVID-19 , Superinfection , Anti-Bacterial Agents/therapeutic use , Humans , Japan/epidemiology , SARS-CoV-2 , Superinfection/drug therapy , Surveys and Questionnaires
15.
PLoS One ; 16(9): e0257452, 2021.
Article in English | MEDLINE | ID: covidwho-1440988

ABSTRACT

OBJECTIVES: A few studies on antibody testing have focused on asymptomatic or mild coronavirus disease 2019 (COVID-19) patients with low initial anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody responses. Anti-SARS-CoV-2 antibody-testing performance was evaluated using blood samples from asymptomatic or mild COVID-19 patients. METHODS: Blood samples were collected from 143 COVID-19 patients during an outbreak on a cruise ship 3 weeks after diagnosis. Simultaneously, a follow-up SARS-CoV-2 genetic test was performed. Samples stored before the COVID-19 pandemic were also used to evaluate the lateral flow immunochromatographic assay (LFA) and electrochemiluminescence immunoassay (ECLIA). Titers of anti-SARS-CoV-2 IgM and IgG antibodies against the nucleocapsid and spike proteins were measured using the enzyme-linked immunosorbent assay to confirm which antibodies were influenced on LFA- and ECLIA- false-negative result in crew-member samples. RESULTS: Sensitivity, specificity, positive-predictive, and negative-predictive values of LFA-detected IgM antibodies were 0.231, 1.000, 1.000, and 0.613, respectively; those of LFA-detected IgG antibodies were 0.483, 0.989, 0.972, and 0.601, respectively; and those of ECLIA-detected total antibodies were 0.783, 1.000, 1.000, and 0.848, respectively. All antibody titers measured using ELISA were significantly lower in blood samples with negative results than in those with positive results in both LFA and ECLIA. In the patients with negative results from the follow-up genetic testing, IgM-, IgG-, and total-antibody positivity rates were 22.9%, 47.6%, and 72.4%, respectively. CONCLUSIONS: These findings suggest that anti-SARS-CoV-2 antibody testing has lower performance in asymptomatic or mild COVID-19 patients than required in the guidelines.


Subject(s)
COVID-19 Serological Testing/methods , COVID-19/diagnosis , COVID-19/immunology , Adult , Antibodies, Viral/immunology , Asymptomatic Infections/epidemiology , COVID-19 Serological Testing/trends , COVID-19 Testing/methods , Disease Outbreaks/prevention & control , Enzyme-Linked Immunosorbent Assay/methods , Female , Humans , Immunoassay/methods , Immunoglobulin G/blood , Immunoglobulin M/blood , Male , Middle Aged , Retrospective Studies , SARS-CoV-2/immunology , Sensitivity and Specificity , Ships
16.
BMJ Open ; 11(9): e053325, 2021 09 21.
Article in English | MEDLINE | ID: covidwho-1435058

ABSTRACT

INTRODUCTION: The COVID-19 pandemic has emerged worldwide. Although several medications have been approved for treating moderate-to-severe COVID-19, very few treatment strategy has been established for patients with mild COVID-19 who do not require oxygen administration. Clarithromycin is a macrolide antimicrobial agent that has been widely used for bacterial respiratory infectious diseases. Clarithromycin also acts an immunomodulating drug and suppresses cytokine storms in viral respiratory diseases, including influenza. In this study, we aim to evaluate the efficacy of clarithromycin in patients with mild COVID-19. METHODS AND ANALYSIS: This is an exploratory, multicentre, open-label, randomised controlled trial. This study was initiated in May 2021 and will end in July 2022. Patients with mild COVID-19 pneumonia who do not require oxygen administration will be enrolled and randomly assigned in a 1:1:1 ratio to group A (administration of clarithromycin 800 mg/day), group B (administration of clarithromycin 400 mg/day) or group C (standard treatment without clarithromycin). The planned number of enrolled patients is 60 (20 patients × three groups). The primary endpoint is the number of days required to improve the clinical symptoms as measured by the severity score. Secondary endpoints include days for recovery of the body temperature, proportion of patients with oxygen administration, inflammatory cytokines, viral load, serum immunoglobulins, peripheral blood lymphocytes, blood biomarkers and pneumonia infiltrations. ETHICS AND DISSEMINATION: The study protocol was approved by the Clinical Research Review Board of Nagasaki University in accordance with the Clinical Trials Act in Japan. The study will be conducted in accordance with the Declaration of Helsinki, the Clinical Trials Act and other current legal regulations in Japan. Written informed consent will be obtained from all the participants. The results of this study will be reported as journal publications. TRIAL REGISTRATION NUMBER: jRCTs071210011.


Subject(s)
COVID-19 , Clarithromycin , Humans , Multicenter Studies as Topic , Oxygen , Pandemics , Porphyrins , Randomized Controlled Trials as Topic , SARS-CoV-2 , Treatment Outcome
17.
Int J Environ Res Public Health ; 18(18)2021 09 13.
Article in English | MEDLINE | ID: covidwho-1409577

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of coronavirus disease 2019 (COVID-19). Real-time RT-PCR is the most commonly used method for COVID-19 diagnosis. However, serological assays are urgently needed as complementary tools to RT-PCR. Hachim et al. 2020 and Burbelo et al. 2020 demonstrated that anti-nucleocapsid(N) SARS-CoV-2 antibodies are higher and appear earlier than the spike antibodies. Additionally, cross-reactive antibodies against N protein are more prevalent than those against spike protein. We developed a less cross-reactive immunoglobulin G (IgG) indirect ELISA by using a truncated recombinant SARS-CoV-2 N protein as assay antigen. A highly conserved region of coronaviruses N protein was deleted and the protein was prepared using an E. coli protein expression system. A total of 177 samples collected from COVID-19 suspected cases and 155 negative control sera collected during the pre-COVID-19 period were applied to evaluate the assay's performance, with the plaque reduction neutralization test and the commercial SARS-CoV-2 spike protein IgG ELISA as gold standards. The SARS-CoV-2 N truncated protein-based ELISA showed similar sensitivity (91.1% vs. 91.9%) and specificity (93.8% vs. 93.8%) between the PRNT and spike IgG ELISA, as well as also higher specificity compared to the full-length N protein (93.8% vs. 89.9%). Our ELISA can be used for the diagnosis and surveillance of COVID-19.


Subject(s)
COVID-19 , Nucleocapsid Proteins , Antibodies, Viral , COVID-19 Testing , Enzyme-Linked Immunosorbent Assay , Escherichia coli , Humans , Immunoglobulin G , Nucleocapsid Proteins/genetics , SARS-CoV-2 , Sensitivity and Specificity , Spike Glycoprotein, Coronavirus
18.
Emerg Infect Dis ; 27(9): 2251-2260, 2021 09.
Article in English | MEDLINE | ID: covidwho-1369629

ABSTRACT

In April 2020, a coronavirus disease (COVID-19) outbreak occurred on the cruise ship Costa Atlantica in Nagasaki, Japan. Our outbreak investigation included 623 multinational crewmembers onboard on April 20. Median age was 31 years; 84% were men. Each crewmember was isolated or quarantined in a single room inside the ship, and monitoring of health status was supported by a remote health monitoring system. Crewmembers with more severe illness were hospitalized. The investigation found that the outbreak started in late March and peaked in late April, resulting in 149 laboratory-confirmed and 107 probable cases of infection with severe acute respiratory syndrome coronavirus 2. Six case-patients were hospitalized for COVID-19 pneumonia, including 1 in severe condition and 2 who required oxygen administration, but no deaths occurred. Although the virus can spread rapidly on a cruise ship, we describe how prompt isolation and quarantine combined with a sensitive syndromic surveillance system can control a COVID-19 outbreak.


Subject(s)
COVID-19 , Ships , Adult , Disease Outbreaks , Humans , Japan/epidemiology , Male , SARS-CoV-2
19.
Eur J Clin Microbiol Infect Dis ; 40(8): 1743-1748, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1323942

ABSTRACT

We evaluated a novel transcription-reverse transcription concerted reaction (TRC) assay that can detect influenza A and B within 15 min using nasopharyngeal swab and gargle samples obtained from patients with influenza-like illness, between January and March 2018 and between January and March 2019. Based on the combined RT-PCR and sequencing results, in the nasal swabs, the sensitivity and specificity of TRC for detecting influenza were calculated as 1.000 and 1.000, respectively. In the gargle samples, the sensitivity and specificity of TRC were 0.946 and 1.000, respectively. The TRC assay showed comparable performance to RT-PCR in the detection of influenza viruses.


Subject(s)
Influenza A virus/isolation & purification , Influenza B virus/isolation & purification , Influenza, Human/diagnosis , Influenza, Human/virology , Nasopharynx/virology , Adult , Aged , Diagnostic Tests, Routine , Female , Humans , Male , Middle Aged , Prospective Studies , Sensitivity and Specificity
20.
J Infect Chemother ; 27(10): 1525-1528, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1313247

ABSTRACT

Polymerase chain reaction (PCR) testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is necessary for confirming a diagnosis of Coronavirus disease 2019 (COVID-19). Here we present a COVID-19 case of an elderly woman whose SARS-CoV-2 PCR tests showed false negative repeatedly by evaluating with different sampling sites and procedures. Nasopharyngeal swabs, suctioned sputum, and tongue swabs were collected for SARS-CoV-2-PCR. As for tongue swabs, we compared between two different sample conditions; one obtained with dry condition and the other obtained with moistened condition inside the oral cavity. SARS-CoV-2-PCR showed positive for an extended period with suctioned sputum samples compared with nasopharyngeal swabs and tongue swabs. No SARS-CoV-2 from a nasopharyngeal swab sample obtained on day 46 after symptoms onset was isolated despite high viral load (183740.5 copies/5µL). An adequate production of neutralizing antibody in a serum sample on day 46 was also confirmed. The number of RNA copies of the tongue swab samples was higher with moistened condition than with dry condition. The present case suggests that the difference of sampling site or sample condition can affect PCR results. High loads viral RNA detection does not always correlate with infectivity.


Subject(s)
COVID-19 , SARS-CoV-2 , Aged , Female , Humans , Nasopharynx , Polymerase Chain Reaction , RNA, Viral , Specimen Handling
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