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1.
Life (Basel) ; 12(6)2022 Jun 08.
Article in English | MEDLINE | ID: covidwho-1884262

ABSTRACT

BACKGROUND: Coronavirus disease 2019 is a global public health concern. As of December 2020, the therapeutic agents approved for coronavirus disease 2019 in Japan were limited to two drugs: remdesivir, an antiviral drug, granted a Special Approval for Emergency on 7 May 2020, and dexamethasone, which has an anti-inflammatory effect. The aim of this study is to evaluate the efficacy of convalescent plasma collected from donors who recovered from coronavirus disease 2019. METHODS: This is an open-label, randomized controlled trial comprising two groups: a convalescent plasma and a standard-of-care group. Plasma administered to patients with coronavirus disease 2019 randomized in the convalescent plasma group of this trial will be plasma that has been collected and stored in an associated study. Patients with a diagnosis of mild coronavirus disease 2019 will be included in this trial. The efficacy of convalescent plasma transfusion will be evaluated by comparing the convalescent plasma group to the standard-of-care group (without convalescent plasma transfusion) with respect to changes in the viral load and other measures. The primary endpoint will be time-weighted average changes in the SARS-CoV-2 virus load in nasopharyngeal swabs from day 0 to days 3 and 5. It is hypothesized that the intervention should result in a decrease in the viral load in the convalescent plasma group until day 5. This endpoint has been used as a change in viral load has and been used as an index of therapeutic effect in several previous studies. DISCUSSION: The proposed trial has the potential to prevent patients with mild COVID-19 from developing a more severe illness. Several RCTs of convalescent plasma therapy have already been conducted in countries outside of Japan, but no conclusion has been reached with respect to the efficacy of convalescent plasma therapy, which is likely in part because of the heterogeneity of the types of target patients, interventions, and endpoints among trials. Actually, previous clinical trials on plasma therapy have shown inconsistent efficacy and are sometimes ineffective in COVID-19 patients with severe disease, which is due to unmeasured neutralizing antibody titer in the COVID-19 convalescent plasma. To improve this issue, in this study, we measure neutralizing activity of convalescent plasma before administration and provide the plasma with high neutralizing activity to the subjects. It is hoped that this study will further evidence to support the role of convalescent plasma therapy in COVID-19.

2.
J Infect Chemother ; 2022 May 17.
Article in English | MEDLINE | ID: covidwho-1851526

ABSTRACT

INTRODUCTION: The post-COVID condition has become a social concern. Although the patient characteristics associated with the development of this condition are partially known, those associated with its persistence have not been identified. METHODS: We conducted a cross-sectional questionnaire-based survey among patients who had recovered from COVID-19 and visited the National Center for Global Health and Medicine between February 2021 and March 2021. Demographic and clinical data, and data regarding the presence and duration of post-COVID conditions were obtained. We identified factors associated with the development and persistence of post-COVID conditions using multivariate logistic and linear regression analyses, respectively. RESULTS: We analyzed 457 of 526 responses (response rate, 86.9%). The median patient age was 47 years. Of these, 378 patients (84.4%) had mild disease in the acute phase. The number of patients with symptoms at 6 and 12 months after onset or diagnosis was 120 (26.3%) and 40 (8.8%), respectively. Women were at risk of developing fatigue (odds ratio [OR]: 2.03, 95% confidence interval [CI]: 1.31-3.14), dysosmia (OR: 1.91, 95%CI: 1.24-2.93), dysgeusia (OR: 1.56, 95%CI: 1.02-2.39), hair loss (OR: 3.00, 95%CI: 1.77-5.09), and persistence of any symptoms (coefficient: 38.0, 95%CI: 13.3-62.8). Younger age and low body mass index were factors for developing dysosmia (OR: 0.96, 95%CI: 0.94-0.98 and OR: 0.94, 95%CI: 0.89-0.99, respectively) and dysgeusia (OR: 0.98, 95%CI: 0.96-1.00 and OR: 0.93, 95%CI: 0.88-0.98, respectively). CONCLUSION: We identified factors involved in the development and persistence of post-COVID conditions. Many patients, even those with mild conditions, experience long-term residual symptoms.

3.
Front Psychiatry ; 13: 781796, 2022.
Article in English | MEDLINE | ID: covidwho-1847220

ABSTRACT

This study explores the factors contributing to the prolonged psychological distress of frontline nurses and physicians caring for COVID-19 patients in hospitals in Singapore and Japan. A cross-sectional survey between September and December 2020 yielded 1,644 responses (23.8%), from 62 nurses and 64 physicians in Singapore and 1,280 nurses and 238 physicians in Japan. Multivariate logistic regression analysis revealed that significant risk factors for prolonged psychological distress included being a frontline nurse [adjusted odds ratio (aOR) = 2.40, 95% confidence interval (CI): 1.24-4.66], having an underlying medical condition (aOR = 1.74, 95% CI: 1.22-2.46), experiencing prejudice because they undertook COVID-19 patient care (aOR = 3.05, 95% CI: 2.23-4.18), having trouble dealing with panicked or uncooperative patients (aOR = 2.36, 95% CI: 1.71-3.25), and experiencing an outbreak of COVID-19 in the hospital (aOR = 2.05, 95% CI: 1.38-3.04). Factors inversely associated with psychological distress included age (OR = 0.98, 95% CI: 0.97-1.00), number of beds in the hospital (aOR = 0.73, 95% CI: 0.57-0.94), clinical practice of carefully putting on and taking off personal protective equipment in daily COVID-19 patient care (aOR = 0.52, 95% CI: 0.37-0.73), and knowledge on COVID-19 (aOR = 0.82, 95% CI: 0.72-0.94). These results could help us identify vulnerable healthcare providers who need urgent mental care during the COVID-19 pandemic. Measures that may reduce psychological strain include adequate supply of medical resources, education on precautionary measures, and communication strategies to combat discrimination against frontline healthcare providers.

4.
Antiviral Res ; 201: 105297, 2022 05.
Article in English | MEDLINE | ID: covidwho-1814106

ABSTRACT

Monoclonal antibody therapy is a promising option for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and a cocktail of antibodies (REGN-COV) has been administered to infected patients with a favorable outcome. However, it is necessary to continue generating novel sets of monoclonal antibodies with neutralizing activity because viral variants can emerge that show resistance to the currently utilized antibodies. Here, we isolated a new cocktail of antibodies, EV053273 and EV053286, from peripheral blood mononuclear cells derived from convalescent patients infected with wild-type SARS-CoV-2. EV053273 exerted potent antiviral activity against the Wuhan wild-type virus as well as the Alpha and Delta variants in vitro, whereas the antiviral activity of EV053286 was moderate, but it had a wide-range of suppressive activity on the wild-type virus as well as the Alpha, Beta, Delta, Kappa, Omicron BA.1, and BA.2 variants. With the combined use of EV053273 and EV053286, we observed similar inhibitory effects on viral replication as with REGN-COV in vitro. We further assessed their activity in vivo by using a mouse model infected with a recently established viral strain with adopted infectious activity in mice. Independent experiments revealed that the combined use of EV053273 and EV053286 or the single use of each monoclonal antibody efficiently blocked infection in vivo. Together with data showing that these two monoclonal antibodies could neutralize REGN-COV escape variants and the Omicron variant, our findings suggest that the EV053273 and EV053286 monoclonal antibody cocktail is a novel clinically applicable therapeutic candidate for SARS-CoV-2 infection.


Subject(s)
Antineoplastic Agents, Immunological , COVID-19 , Antibodies, Monoclonal , Antibodies, Monoclonal, Humanized , Antibodies, Neutralizing , Antibodies, Viral , Antiviral Agents/pharmacology , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Drug Combinations , Humans , Leukocytes, Mononuclear , SARS-CoV-2 , Spike Glycoprotein, Coronavirus
5.
JPRN; 15/04/2022; TrialID: JPRN-jRCT1050220004
Clinical Trial Register | ICTRP | ID: ictrp-JPRN-jRCT1050220004

ABSTRACT

Condition:

COVID-19

Primary outcome:

Descriptive statistics on the presence or absence of spontaneous symptoms after vaccination and their description

Criteria:

Inclusion criteria: 1) Persons who have received or will receive the COVID-19 vaccine
2) The applicant must have access to the application via his/her smartphone and must be able to complete the evaluation and electronic questionnaire on the application.
3) Those who have read and fully understood the consent document for participation in this study and have agreed to be a research subject of their own free will.

Exclusion criteria: 1) Persons who do not agree to participate in this study

6.
Geriatric Medicine ; 60(2):95-101, 2022.
Article in Japanese | Ichushi | ID: covidwho-1777089
8.
Global health & medicine ; 4(1):61-63, 2022.
Article in English | EuropePMC | ID: covidwho-1738177

ABSTRACT

Summary Coronavirus disease (COVID-19) causes myocardial injury by inducing a cytokine storm in severe cases. Studies have reported that myocardial injury persists for a prolonged period during COVID-19 recovery, and cardiac troponin is a useful indicator of myocardial injury. The interleukin-6 (IL-6) level is known to be associated with the morbidity and mortality of COVID-19, but this association has not been studied during recovery. The current study examined the association between IL-6 levels and myocardial damage during COVID-19 recovery. Four of 209 patients (1.9%) who recovered from COVID-19 had elevated IL-6 levels. All 4 patients tested positive for high-sensitivity troponin T, and 3 patients had subclinical left ventricular (LV) dysfunction according to echocardiography. Positivity for IL-6 during COVID-19 recovery suggests ongoing myocardial damage due to inflammation.

9.
Int J Infect Dis ; 119: 18-20, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1739799

ABSTRACT

We present a case of a 58-year-old Japanese man with a history of 2 previous COVID-19 infections, who received 2 doses of mRNA-1273 vaccine. We are not aware of any previous study regarding antibody tendency after 2 infections and 2 vaccinations. We evaluated his IgG titer of antispike protein and neutralizing activity from the first infection before and after 2 doses of vaccine. Both antispike IgG titer and neutralizing activity showed a tendency to decline almost 1 year after initial infection; they rapidly increased after the first vaccination, and they remained high after the second vaccination. Although this is a single case report, it seems to have generalizability because the findings are consistent with previous reports regarding single infections or 3 doses of vaccination. Our findings suggest that a single booster shot may provide sufficient protection and aid the understanding of immunologic responses of vaccination in patients with COVID-19 with history of re-infection.


Subject(s)
COVID-19 , Antibodies, Neutralizing , Antibodies, Viral , Antibody Formation , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Immunoglobulin G , Male , Middle Aged , Reinfection , SARS-CoV-2 , Vaccination
10.
Circ J ; 86(3): 464-471, 2022 Feb 25.
Article in English | MEDLINE | ID: covidwho-1714686

ABSTRACT

BACKGROUND: Cardiovascular complications of coronavirus disease 2019 (COVID-19) are critical for prognosis but have not been elucidated in Japan.Methods and Results:The COVID-19 Registry Japan, which included data from 19,853 individuals at the end of 2020, was analyzed. The incidences of cardiovascular complications were 0.098% for myocarditis/pericarditis/cardiomyopathy, 0.48% for ventricular tachycardia/fibrillation, 0.17% for myocardial ischemia, 0.062% for endocarditis, 0.59% for deep vein thrombosis, 0.19% for pulmonary embolism, and 0.37% for cerebral infarction/hemorrhage. Excluding endocarditis, all complications were associated with increased in-hospital mortality. CONCLUSIONS: Cardiovascular complications of COVID-19 were infrequent in Japan but were associated with poor prognosis.


Subject(s)
COVID-19/complications , Cardiovascular Diseases/epidemiology , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , Cardiovascular Diseases/complications , Female , Hospitalization , Humans , Incidence , Japan/epidemiology , Male , Middle Aged , Registries , SARS-CoV-2
11.
J Infect Chemother ; 28(6): 729-734, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1705478

ABSTRACT

INTRODUCTION: Rapid, simple, and accurate methods are required to diagnose coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to evaluate the performance of the QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAstat-SARS-CoV-2), a rapid multiplex PCR assay for SARS-CoV-2 detection. METHODS: Nasopharyngeal swabs (NPS) that were obtained from patients with COVID-19 who were diagnosed at the National Center for Global Health and Medicine were used in this study. When the NPS samples were found to be negative for SARS-CoV-2 after treatment, they were used as negative samples. We evaluated the performance of the QIAstat-SARS-CoV-2 comparing SARS-CoV-2 detection with the National Institute of Infectious Diseases in Japan-recommended real-time polymerase chain reaction (RT-PCR) method (NIID-RT-PCR). RESULTS: In total, 45 NPS samples were analyzed. The proportion of overall agreement between QIAstat-SARS-CoV-2 and NIID-RT-PCR on 45 samples was 91.0% with a sensitivity of 84.0% (21/25), specificity at 100% (20/20), negative predictive value at 83.3% (20/24), and positive predictive value at 100% (21/21). There were no patients with co-infections with pathogens other than SARS-CoV-2. CONCLUSIONS: QIAstat-SARS-CoV-2 showed a high agreement in comparison with the NIID-RT-PCR for the detection of SARS-CoV-2. The QIAstat-SARS-CoV-2 also provided a rapid and accurate diagnosis for COVID-19, even when the concurrent detection of other respiratory pathogens was desired, and therefore, has the potential to direct appropriate therapy and infection control precautions.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/diagnosis , Humans , Multiplex Polymerase Chain Reaction/methods , Respiratory System , SARS-CoV-2/genetics , Sensitivity and Specificity
12.
Journal of Japan Surgical Society ; 122(6):600-605, 2021.
Article in Japanese | Ichushi | ID: covidwho-1678952
13.
Int J Epidemiol ; 2021 Dec 11.
Article in English | MEDLINE | ID: covidwho-1566019

ABSTRACT

BACKGROUND: The aim of this study was to identify associations between smoking status and the severity of COVID-19, using a large-scale data registry of hospitalized COVID-19 patients in Japan (COVIREGI-JP), and to explore the reasons for the inconsistent results previously reported on this subject. METHODS: The analysis included 17 666 COVID-19 inpatients aged 20-89 years (10 250 men and 7416 women). We graded the severity of COVID-19 (grades 0 to 5) according to the most intensive treatment required during hospitalization. The smoking status of severe grades 3/4/5 (invasive mechanical ventilation/extracorporeal membrane oxygenation/death) and separately of grade 5 (death) were compared with that of grade 0 (no oxygen, reference group) using multiple logistic regression. Results were expressed as odds ratios (OR) and 95% confidence intervals (CI) adjusted for age and other factors considering the potential intermediate effects of comorbidities. RESULTS: Among men, former smoking significantly increased the risk of grade 3/4/5 and grade 5, using grade 0 as a reference group, with age- and admission-date-adjusted ORs (95% CI) of 1.51 (1.18-1.93) and 1.65 (1.22-2.24), respectively. An additional adjustment for comorbidities weakened the ORs. Similar results were seen for women. Current smoking did not significantly increase the risk of grade 3/4/5 and grade 5 in either sex. CONCLUSIONS: The severity of COVID-19 was not associated with current or former smoking per se but with the comorbidities caused by smoking. Thus, smoking cessation is likely to be a key factor for preventing smoking-related disease and hence for reducing the risk of severe COVID-19.

14.
2021.
Preprint in English | Other preprints | ID: ppcovidwho-296101

ABSTRACT

Summary There are several recommendations for the use of personal protective equipment (PPE) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, the selection of appropriate PPE for the current situation remains controversial. We measured serum antibody titers for SARS-CoV-2 in 10 participants who were engaged in the operation of charter flights for the evacuation of Japanese residents from Hubei Province. All participants wore PPE in accordance with Centers for Disease Control and Prevention guidelines. A total of 17 samples were tested, and all were seronegative. Hence, we conclude that the current PPE recommendation is effective to protect healthcare workers from SARS-CoV-2 infection.

15.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-295503

ABSTRACT

Background: Long coronavirus disease (COVID) has been a social concern. Though patient characteristics associated with the development of long COVID are partially known, those associated with its persistence have not been identified. Methods: We conducted a cross-sectional questionnaire survey of patients after COVID-19 recovery who visited the National Center for Global Health and Medicine between February 2020 and March 2021. Demographic and clinical data and data regarding the presence and duration of long COVID were obtained. We identified factors associated with the development and persistence of long COVID using multivariate logistic and linear regression analysis, respectively. Results: We analyzed 457 of 526 responses (response rate, 86.9%). The median age was 47 years, and 378 patients (84.4%) had mild disease in the acute phase. The number of patients with any symptoms after 6 and 12 months after onset or diagnosis were 120 (26.3%) and 40 (8.8%), respectively. Women were at risk for development of fatigue (odds ratio [OR]: 2.03, 95% confidence interval [CI]: 1.31-3.14), dysosmia (OR: 1.91, 95% CI: 1.24-2.93), dysgeusia (OR: 1.56, 95% CI: 1.02-2.39), and hair loss (OR: 3.00, 95% CI: 1.77-5.09) and for persistence of any symptoms (coefficient: 38.0, 95% CI: 13.3-62.8). Younger age and low body mass index were risk factors for developing dysosmia (OR: 0.96, 95% CI: 0.94-0.98 and OR: 0.94, 95% CI: 0.89-0.99, respectively) and dysgeusia (OR: 0.98, 95% CI: 0.96-1.00 and OR: 0.93, 95% CI: 0.88-0.98, respectively). Conclusion: We identified risk factors for the development and persistence of long COVID. Many patients suffer from long-term residual symptoms, even in mild cases.

16.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-293380

ABSTRACT

Background: Long coronavirus disease (COVID) has been a social concern. Though patient characteristics associated with the development of long COVID are partially known, those associated with its persistence have not been identified. Methods: We conducted a cross-sectional questionnaire survey of patients after COVID-19 recovery who visited the National Center for Global Health and Medicine between February 2020 and March 2021. Demographic and clinical data and data regarding the presence and duration of long COVID were obtained. We identified factors associated with the development and persistence of long COVID using multivariate logistic and linear regression analysis, respectively. Results: We analyzed 457 of 526 responses (response rate, 86.9%). The median age was 47 years, and 378 patients (84.4%) had mild disease in the acute phase. The number of patients with any symptoms after 6 and 12 months after onset or diagnosis were 120 (26.3%) and 40 (8.8%), respectively. Women were at risk for development of fatigue (odds ratio [OR]: 2.03, 95% confidence interval [CI]: 1.31-3.14), dysosmia (OR: 1.91, 95% CI: 1.24-2.93), dysgeusia (OR: 1.56, 95% CI: 1.02-2.39), and hair loss (OR: 3.00, 95% CI: 1.77-5.09) and for persistence of any symptoms (coefficient: 38.0, 95% CI: 13.3-62.8). Younger age and low body mass index were risk factors for developing dysosmia (OR: 0.96, 95% CI: 0.94-0.98 and OR: 0.94, 95% CI: 0.89-0.99, respectively) and dysgeusia (OR: 0.98, 95% CI: 0.96-1.00 and OR: 0.93, 95% CI: 0.88-0.98, respectively). Conclusion: We identified risk factors for the development and persistence of long COVID. Many patients suffer from long-term residual symptoms, even in mild cases.

17.
Intensivist ; 13(3):471-476, 2021.
Article in Japanese | Ichushi | ID: covidwho-1519279
18.
The Journal of Biomedical Science and Biosafety ; 33(3):111-117, 2021.
Article in Japanese | Ichushi | ID: covidwho-1519278
19.
IDCases ; 26: e01343, 2021.
Article in English | MEDLINE | ID: covidwho-1517180

ABSTRACT

Remdesivir is an antiviral drug that results in clinical improvement after five days of treatment and accelerates recovery by 31%. No studies have discussed the pharmacokinetic analysis of remdesivir in patients with severe COVID-19 requiring extracorporeal membrane oxygenation (ECMO). A 63-year-old American man who underwent mechanical ventilation and ECMO for severe COVID-19 was administered remdesivir for ten days. The loading dosage was 200 mg at 7 PM on day 12 and 100 mg daily at 0:00 PM from day 13-21, administered within 1 h. The pharmacokinetic analysis was performed. The serum creatinine concentration was within the normal range of 0.5-0.7 mg/dL during treatment. According to the pharmacokinetic analysis, the plasma concentrations of remdesivir and GS-441524 4 h after administration (C4) were 662 ng/mL and 58 ng/mL, respectively, and the concentrations 18 h after administration (C18) were 32 ng/mL and 44 ng/mL, respectively. Therefore, the half-life of remdesivir and GS-441524 was 3.2 and 35.1 h, respectively. Monitoring the plasma concentrations of remdesivir and GS-441524 in patients undergoing ECMO may be necessary.

20.
Non-conventional in Japanese | [Unspecified Source], Grey literature | ID: grc-750737

ABSTRACT

Current status of the novel coronavirus : an urgent discussion / Kentaro Iwata, Naoki Kishida, Kutsuna Kenshi, Fumie Sakamoto[ speaker] ・Novel coronavirus infection : extra edition / Kutsuna Kenshi [author] ・Infectious Diseases and the Infectious Disease Consultant : Dr. Kishida's Challenge / Kishida Naoki [author]

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