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Background: Ensitrelvir is a SARS-CoV-2 3CL protease inhibitor approved in Japan under emergency regulatory approval system as an oral treatment for COVID-19. Here we report the key analysis results of 125 mg group of phase3 part (SCORPIO-SR). Method(s): This study was a multicenter, randomized, double-blind, placebocontrolled study. Regardless of SARS-CoV-2 vaccination status and presence of risk factors for severe disease, patients with mild-to-moderate COVID-19 within 120 hours from onset were randomized to oral administration of ensitrelvir 125 mg (375 mg loading dose on Day1), ensitrelvir 250 mg (750 mg loading dose on Day1), and placebo once daily, for 5 days. The primary endpoint was time to resolution of 5 symptoms of COVID-19 (stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness), and the key secondary endpoints include change from baseline on Day4 in the amount of SARS-CoV-2 viral RNA and time to first negative of viral titer. The primary population for the primary and key secondary endpoints was patients with <72 hours from onset to randomization. Result(s): Median time to resolution of 5 symptoms was significantly shorter in 125 mg group (n=336, 167.9 hours) than placebo group (n=321, 192.2 hours) (p=0.0407). Mean change of viral RNA levels from baseline (log10 copies/mL) on Day4 was significantly greater in 125 mg group (-2.48) than in placebo group (-1.01) (p< 0.0001). The time to first negative of viral titer was significantly shorter in 125 mg group (n=199, 36.2 hours) compared to placebo group (n=211, 65.3 hours) (p< 0.0001). Mean changes from baseline in viral titers [log10(TCID50)/mL] were significantly greater in 125mg group on Day2 (-0.807, n=196) and Day4 (-1.108, n=197) than in the placebo group (-0.395, n=208 and -0.850, n=207, respectively) (p< 0.0001). (Table Presented) In the patients randomized within 120 hours of onset, median time to resolution of 5 symptoms was 189.7 hours in 125 mg group (n=582) and 200.3 hours in placebo group (n=572) (p=0.4352). No deaths or serious adverse drug reactions were reported in either group, and the incidence of serious adverse events between the two groups was comparable. Conclusion(s): Ensitrelvir demonstrated a significant reduction in the time to resolution of 5 typical symptoms of COVID-19, robust antiviral effects and good tolerability.
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BNT162b2, an mRNA-based SARS-CoV-2 vaccine (Pfizer- BioNTech), is one of the most effective COVID-19 vaccines and has been approved by more than 130 countries worldwide. However, several studies have reported that the COVID-19 vaccine shows high interpersonal variability in terms of humoral and cellular responses, such as those with respect to SARS-CoV-2 spike protein immunoglobulin (Ig)G, IgA, IgM, neutralizing antibodies, and CD4+ & CD8+ T cells. The objective of this study is to investigate the kinetic changes in anti-SARS-CoV-2 spike IgG (IgG-S) profiles and adverse reactions and their associations with HLA profiles among 100 hospital workers from the Center Hospital of the National Center for Global Health and Medicine (NCGM), Tokyo, Japan. DQA1*03:03:01 (p = 0.017;OR 2.80, 95% CI 1.05-7.25) was significantly associated with higher IgG-S production after two doses of BNT162b2 while DQB1*06:01:01:01 (p = 0.028, OR 0.27, 95% CI 0.05-0.94) was significantly associated with IgG-S declines after two doses of BNT162b2. No HLA alleles were significantly associated with either local symptoms or fever. However, C*12:02:02 (p = 0.058;OR 0.42, 95% CI 0.15-1.16), B*52:01:01 (p = 0.031;OR 0.38, 95% CI 0.14-1.03), DQA1*03:02:01 (p = 0.028;OR 0.39, 95% CI 0.15-1.00) and DPB1*02:01:02 (p = 0.024;OR 0.45, 95% CI 0.21-0.97) appeared significantly associated with protection against systemic symptoms after two doses of BNT162b2 vaccination. Further studies with larger sample sizes are clearly warranted to determine HLA allele associations with the production and long-term sustainability of IgG-S after COVID-19 vaccination.
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Objective: The role of angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB) in the pandemic context of coronavirus disease 2019 (COVID-19) continues to be debated. Patients with hypertension, diabetes mellitus, chronic renal failure, cerebro-cardiovascular disease, or chronic obstructive pulmonary disease (COPD), who often use ACEi/ARB, may affect risk of severe COVID-19. However, there are no data available on the association of ACEi/ARB use with COVID-19 severity in this population. Design and method: This study is an observational study of patients with a positive SARS-CoV-2 test and inpatient treatment at a healthcare facility, using the registry information of COVIREGI-JP. Our primary outcomes were consisting of in-hospital death, ventilator support, extracorporeal membrane oxygenation support, and ICU admission. Out of the 6,055 patients, 1,921 patients with preexisting hypertension, diabetes mellitus, chronic renal failure, cerebro-cardiovascular disease, or COPD were enrolled. We also evaluated 1,097 patients with hypertension. Results: Factors associated with an increased risk of the primary outcomes were aging, male sex, COPD, severe renal impairment, and diabetes mellitus. No correlations were observed with ACEi/ARB, cerebro-cardiovascular diseases, or hypertension. Associated factors in male patients were aging, renal impairment, hypertension, and diabetes. In female patients, factors associated with an increased risk were aging, ACEi/ARB, renal impairment, and diabetes, whereas hypertension was associated with a lower risk of the primary outcomes. In patients with hypertension, factors associated with an increased risk of the primary outcomes were aging, male sex, severe renal impairment, and diabetes mellitus, but not ACEi/ ARB, cerebro-cardiovascular diseases, or COPD. Conclusions: Independent factors for the primary outcomes were aging, male sex, COPD, severe renal impairment, and diabetes, but not ACEi/ARB, in the COVID-19 patients with preexisting hypertension, diabetes mellitus, chronic renal failure, cerebro-cardiovascular disease or COPD. Based on this registry data analysis, more detailed data collection and analysis is needed with the cooperation of multiple healthcare facilities.
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Background: Information regarding effects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant strains on clinical manifestations and outcomes of coronavirus disease 2019 (COVID-19) in pregnant women is limited. Methods: A retrospective observational study was conducted using the data from the nationwide COVID-19 registry in Japan. We identified pregnant patients with symptomatic COVID-19 hospitalized during the study period. The Delta and Omicron variants of concern (VOC) predominant periods were defined as August 1 to December 31, 2021 and January 1 to May 31, 2022, respectively. Clinical characteristics were compared between the patients in the Delta and Omicron VOC periods. In addition, logistic regression analysis was performed to identify risk factors for developing moderate-to-severe COVID-19. Results: During the study period, 310 symptomatic COVID-19 cases of pregnant women were identified;111 and 199 patients were hospitalized during the Delta and Omicron VOC periods, respectively. Runny nose and sore throat were more common, and fatigue, dysgeusia, and olfactory dysfunction were less common manifestations observed in the Omicron VOC period. In the multivariable logistic regression analysis, onset during the later stage of pregnancy (OR: 2.08 [1.24–3.71]) and onset during the Delta VOC period (OR: 2.25 [1.08–4.90]) were independently associated with moderate-to-severe COVID-19, whereas two doses of SARS-CoV-2 vaccine were protective against developing moderate-to-severe COVID-19 (OR: 0.34 [0.13–0.84]). Conclusions: Clinical manifestations of COVID-19 in pregnant women differed between the Delta and Omicron VOC periods. SARS-CoV-2 vaccination was still effective in preventing severe COVID-19 throughout the Delta and Omicron VOC periods. © 2022 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases
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Background: Information regarding effects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant strains on clinical manifestations and outcomes of coronavirus disease 2019 (COVID-19) in pregnant women is limited. Methods: A retrospective observational study was conducted using the data from the nationwide COVID-19 registry in Japan. We identified pregnant patients with symptomatic COVID-19 hospitalized during the study period. The Delta and Omicron variants of concern (VOC) predominant periods were defined as August 1 to December 31, 2021 and January 1 to May 31, 2022, respectively. Clinical characteristics were compared between the patients in the Delta and Omicron VOC periods. In addition, logistic regression analysis was performed to identify risk factors for developing moderate-to-severe COVID-19. Results: During the study period, 310 symptomatic COVID-19 cases of pregnant women were identified;111 and 199 patients were hospitalized during the Delta and Omicron VOC periods, respectively. Runny nose and sore throat were more common, and fatigue, dysgeusia, and olfactory dysfunction were less common manifestations observed in the Omicron VOC period. In the multivariable logistic regression analysis, onset during the later stage of pregnancy (OR: 2.08 [1.24-3.71]) and onset during the Delta VOC period (OR: 2.25 [1.08-4.90]) were independently associated with moderate-to-severe COVID-19, whereas two doses of SARS-CoV-2 vaccine were protective against developing moderate-to-severe COVID-19 (OR: 0.34 [0.13-0.84]). Conclusions: Clinical manifestations of COVID-19 in pregnant women differed between the Delta and Omicron VOC periods. SARS-CoV-2 vaccination was still effective in preventing severe COVID-19 throughout the Delta and Omicron VOC periods.
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Introduction: Anterior nasal sampling (AN) might be more convenient for patients than NP sampling to diagnose coronavirus disease. This study investigated the feasibility of rapid antigen tests for AN sampling, and the factors affecting the test accuracy. Methods: This single-center prospective study evaluated one qualitative (ESP) and two quantitative (LUMI and LUMI-P) rapid antigen tests using AN and NP swabs. Symptomatic patients aged 20 years or older, who were considered eligible for reverse-transcription quantitative polymerase chain reaction using NP samples within 9 days of onset were recruited. Sensitivity, specificity, and positive and negative concordance rates between AN and NP samples were assessed for the rapid antigen tests. We investigated the characteristics that affected the concordance between AN and NP sampling results. Results: A total of 128 cases were recruited, including 28 positive samples and 96 negative samples. The sensitivity and specificity of AN samples using ESP were 0.81 and 1.00, while those of NP samples were 0.94 and 1.00. The sensitivity of AN and NP samples was 0.91 and 0.97, respectively, and specificity was 1.00, for both LUMI and LUMI-P. The positive concordance rates of AN to NP sampling were 0.87, 0.94, and 0.85 for ESP, LUMI, and LUMI-P, respectively. No factor had a significant effect on the concordance between the sampling methods. Conclusions: ESP, LUMI, and LUMI-P showed practical diagnostic accuracy for AN sampling compared to NP sampling. There was no significant factor affecting the concordance between AN and NP sampling for these rapid antigen tests. © 2022 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases
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OBJECTIVE: The aim of this study was to investigate the epidemiology of post-COVID conditions beyond 12 months and identify factors associated with the persistence of each condition. STUDY DESIGN: This was a cross-sectional questionnaire-based survey. METHODS: We conducted the survey among patients who had recovered from COVID-19 and visited our institute between February 2020 and November 2021. Demographic and clinical data and data regarding the presence and duration of post-COVID conditions were obtained. We identified factors associated with the persistence of post-COVID conditions using multivariable linear regression analyses. RESULTS: Of 1148 surveyed patients, 502 completed the survey (response rate, 43.7%). Of these, 393 patients (86.4%) had mild disease in the acute phase. The proportion of participants with at least one symptom at 6, 12, 18, and 24 months after symptom onset or COVID-19 diagnosis was 32.3% (124/384), 30.5% (71/233), 25.8% (24/93), and 33.3% (2/6), respectively. The observed associations were as follows: fatigue persistence with moderate or severe COVID-19 (ß = 0.53, 95% confidence interval [CI] = 0.06-0.99); shortness of breath with moderate or severe COVID-19 (ß = 1.39, 95% CI = 0.91-1.87); cough with moderate or severe COVID-19 (ß = 0.84, 95% CI = 0.40-1.29); dysosmia with being female (ß = -0.57, 95% CI = -0.97 to -0.18) and absence of underlying medical conditions (ß = -0.43, 95% CI = -0.82 to -0.05); hair loss with being female (ß = -0.61, 95% CI = -1.00 to -0.22), absence of underlying medical conditions (ß = -0.42, 95% CI = -0.80 to 0.04), and moderate or severe COVID-19 (ß = 0.97, 95% CI = 0.41-1.54); depressed mood with younger age (ß = -0.02, 95% CI = -0.04 to -0.004); and loss of concentration with being female (ß = -0.51, 95% CI = -0.94 to -0.09). CONCLUSIONS: More than one-fourth of patients after recovery from COVID-19, most of whom had had mild disease in the acute phase, had at least one symptom at 6, 12, 18, and 24 months after onset of COVID-19, indicating that not a few patients with COVID-19 suffer from long-term residual symptoms, even in mild cases.
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COVID-19 , Humans , Female , Male , Post-Acute COVID-19 Syndrome , COVID-19 Testing , Cross-Sectional Studies , CoughABSTRACT
BACKGROUND: The risk factors for coronavirus disease (COVID-19) among healthcare workers (HCWs) might have changed since the emergence of the highly immune evasive Omicron variant. AIM: To compare the risk factors for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among HCWs during the Delta- and Omicron-predominant periods. METHODS: Using data from repeated serosurveys among the staff of a medical research centre in Tokyo, two cohorts were established: Delta period cohort (N = 858) and Omicron period cohort (N = 652). The potential risk factors were assessed using a questionnaire. Acute/current or past SARS-CoV-2 infection was identified by polymerase chain reaction or anti-nucleocapsid antibody tests, respectively. Poisson regression was used to calculate the risk ratio (RR) of infection risk. FINDINGS: The risk of SARS-CoV-2 infection during the early Omicron-predominant period was 3.4-fold higher than during the Delta-predominant period. Neither working in a COVID-19-related department nor having a higher degree of occupational exposure to SARS-CoV-2 was associated with an increased infection risk during both periods. During the Omicron-predominant period, infection risk was higher among those who spent ≥30 min in closed spaces, crowded spaces, and close-contact settings without wearing mask (≥3 times versus never: RR: 6.62; 95% confidence interval: 3.01-14.58), whereas no such association was found during the Delta period. CONCLUSION: Occupational exposure to COVID-19-related work was not associated with the risk of SARS-CoV-2 infection in the Delta or Omicron period, whereas high-risk behaviours were associated with an increased infection risk during the Omicron period.
Subject(s)
COVID-19 , Humans , COVID-19/epidemiology , Japan/epidemiology , SARS-CoV-2 , Risk Factors , Health PersonnelABSTRACT
Background. Two years have passed since the global outbreak of COVID-19 began. Vaccines and many therapeutic agents have now been developed, and treatment is being conducted in accordance with guidelines. In general, it takes a long time for guidelines to be established, as a large amount of clinical data is required. Therefore, in the early and middle stages of an epidemic, treatment is often based on experience at individual centers. This study focuses on two drugs, Favipiravir and Steroid, and investigates how trends in drug use changed in different regions. Methods. We compared the proportion of drug administered patients in the COVID-19 Registry Japan (COVIREGI-JP). Data from four COVID-19 epidemic waves, from January 2020 to June 2021, were included for the analysis. To compare regional trends, 10 categories were used based on existing classifications. In addition, Tokyo and Osaka were accounted for separately, for a total of 12 regions. Severity of each case was divided into mild, moderate 1, moderate 2 and severe based on the condition on admission, and the proportion of Favipiravir or Steroid administered cases was calculated for moderate 2 and severe cases. Results. Favipiravir was administered to more than 50-100% of patients in the first wave. Thereafter, it declined nationwide, with sharp falls in Tokyo (34.9%, 16.5% and 4.3%) and Osaka (48.8%, 41.8% and 8.0%). In Hokkaido, on the other hand, 82.4%, 53.7% and 59.8% of the cases still continued to receive Favipiravir. In the first wave, Steroid was administered to 20-40% of cases. The proportion gradually increased, with 50-80% in the second wave, and 85.5% in Tokyo, 93.4% in Osaka and 90.2% in Hokkaido in the fourth wave, the majority of cases. Changes over time in the proportions of cases treated with Favipiravir and Steroid in each region. The top four and middle four panels show the proportion of cases treated with Favipiravir and Steroid, respectively. The lower epi-curve shows the number of COVID-19 cases in Japan. Conclusion. We confirmed that the more effective treatment was rapidly spreading throughout the country. More information is available in areas with a large number of cases, such as Tokyo and Osaka, and in facilities that see a large number of cases. On the other hand, it may be difficult for smaller facilities or facilities that do not see many COVID-19 cases. Information from registry studies would be useful in making more effective treatments available earlier and more widely. We believe that further use of COVIREGI-JP would promote standardization of treatment.
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Background. Neutralizing antibody therapy such as casirivimab/imdevimab is known to significantly reduce the viral load of SARS-CoV-2, but there is limited study on the clinical prognosis of neutralizing antibody therapy, especially in Asia, and the dynamics of cytokines is unknown worldwide. Several cytokines have been investigated as biomarkers to predict oxygen demand, among which CCL17 and INF3 have received approved and covered by the national health insurance in Japan. Methods. Between July 2021 - December 2021, patient's demographic, laboratory, radiological findings, prognosis, and cytokine kinetics (IFN-gamma3, CCL17) at National Center for Global Health and Medicine, Tokyo, Japan, were analyzed using medical charts and serum samples. Univariate analysis was performed using Fisher's exact probability test and Mann-Whitney U test to evaluate the clinical characteristics of the group with oxygen demand compared with those of the group without oxygen demand. Results. Thirty-four patients were analyzed. The median age of the cohort was 57.5 years (IQR 52.8-67.3), and 25 (73.5%) were male. Eight patients (23.5%) had been fully vaccinated and three patients (8.8%) had been vaccinated once. The severity of disease before casirivimab/imdevimab was asymptomatic in two (5.9%), mild in 12 (35.3%), moderate in 20 (58.8%) cases. Of the 17 cases in which mutant strains were identified, 16 were delta strains. The IFN-gamma3 level (pg/mL) before casirivimab/imdevimab was significantly higher (7.6 vs. 17.2, p = 0.005), while the CCL17 level (pg/mL) was significantly lower (148.8 vs. 64.2, p = 0.036) in the group with oxygen demand during the therapeutic course compared to those in the group without oxygen demand. After casirivimab/imdevimab was administered, the IFN-gamma3 level decreased to a median of 0.0 (IQR 0.0-0.3), while the CCL17 level increased to median of 220.3 (IQR 135.8-304.8), with no statistically significant differences between both groups (Figure 1). None of the patients became seriously ill. Figure 1A and 1B show the changing of the cytokine dynamics in COVID-19 patients who were treated with casirivimab/imdevimab on IFN-gamma3 level and CCL17 level, respectively. Conclusion. There was a statistically significant difference between IFN-gamma3 and CCL17 levels before casirivimab/imdevimab in both groups. Our results suggest that casirivimab/immudevimab may improve the clinical prognosis for COVID-19 patients with delta strains.
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BACKGROUND: Information regarding effects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant strains on clinical manifestations and outcomes of coronavirus disease 2019 (COVID-19) in pregnant women is limited. METHODS: A retrospective observational study was conducted using the data from the nationwide COVID-19 registry in Japan. We identified pregnant patients with symptomatic COVID-19 hospitalized during the study period. The Delta and Omicron variants of concern (VOC) predominant periods were defined as August 1 to December 31, 2021 and January 1 to May 31, 2022, respectively. Clinical characteristics were compared between the patients in the Delta and Omicron VOC periods. In addition, logistic regression analysis was performed to identify risk factors for developing moderate-to-severe COVID-19. RESULTS: During the study period, 310 symptomatic COVID-19 cases of pregnant women were identified;111 and 199 patients were hospitalized during the Delta and Omicron VOC periods, respectively. Runny nose and sore throat were more common, and fever, fatigue, dysgeusia, and olfactory dysfunction were less common manifestations observed in the Omicron VOC period. In the multivariable logistic regression analysis, onset during the later stage of pregnancy (OR: 2.08 [1.24-3.71]) and onset during the Delta VOC period (OR: 2.25 [1.08-4.90]) were independently associated with moderate-to-severe COVID-19, whereas two doses of SARS-CoV-2 vaccine were protective against developing moderate-to-severe COVID-19 (OR: 0.34 [0.13-0.84]). CONCLUSIONS: Clinical manifestations of COVID-19 in pregnant women differed between the Delta and Omicron VOC periods. SARS-CoV-2 vaccination was still effective in preventing severe COVID-19 throughout the Delta and Omicron VOC periods.
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OBJECTIVES: To investigate the prevalence of post coronavirus disease (COVID-19) condition of the Omicron variant in comparison to other strains. STUDY DESIGN: A single-center cross-sectional study. METHODS: Patients who recovered from Omicron COVID-19 infection (Omicron group) were interviewed via telephone, and patients infected with other strains (control group) were surveyed via a self-reporting questionnaire. Data on patients' characteristics, information regarding the acute-phase COVID-19, as well as presence and duration of COVID-19-related symptoms were obtained. Post COVID-19 condition in this study was defined as a symptom that lasted for at least 2 months, within 3 months of COVID-19 onset. We investigated and compared the prevalence of post COVID-19 condition in both groups after performing propensity score matching. RESULTS: We conducted interviews for 53 out of 128 patients with Omicron and obtained 502 responses in the control group. After matching cases with controls, 18 patients from both groups had improved covariate balance of the factors: older adult, female sex, obesity, and vaccination status. There were no significant differences in the prevalence of each post COVID-19 condition between the two groups. The number of patients with at least one post COVID-19 condition in the Omicron and control groups were 1 (5.6%) and 10 (55.6%) (p = 0.003), respectively. CONCLUSIONS: The prevalence of post Omicron COVID-19 conditions was less than that of the other strains. Further research with a larger sample size is needed to investigate the precise epidemiology of post COVID-19 condition of Omicron, and its impact on health-related quality of life and social productivity.
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COVID-19 , SARS-CoV-2 , Aged , COVID-19/epidemiology , Cross-Sectional Studies , Female , Humans , Quality of LifeABSTRACT
Coronavirus disease 2019 (COVID-19) was announced as an outbreak by the World Health Organization (WHO) in January 2020 and as a pandemic in March 2020. The majority of infected individuals have experienced no or only mild symptoms, ranging from fully asymptomatic cases to mild pneumonic disease. However, a minority of infected individuals develop severe respiratory symptoms. The objective of this study was to identify susceptible HLA alleles and clinical markers that can be used in risk prediction models for the early identification of severe COVID-19 among hospitalized COVID-19 patients. A total of 137 patients with mild COVID-19 (mCOVID-19) and 53 patients with severe COVID-19 (sCOVID-19) were recruited from the Center Hospital of the National Center for Global Health and Medicine (NCGM), Tokyo, Japan for the period of February-August 2020. High-resolution sequencing-based typing for eight HLA genes was performed using next-generation sequencing. In the HLA association studies, HLA-A∗11:01:01:01 [Pc = 0.013, OR = 2.26 (1.27-3.91)] and HLA-C∗12:02:02:01∼HLAB∗ 52:01:01:02 [Pc = 0.020, OR = 2.25 (1.24-3.92)] were found to be significantly associated with the severity of COVID-19. After multivariate analysis controlling for other confounding factors and comorbidities, HLAA∗ 11:01:01:01 [P = 3.34E-03, OR = 3.41 (1.50-7.73)], age at diagnosis [P = 1.29E-02, OR= 1.04 (1.01-1.07)] and sex at birth [P = 8.88E-03, OR= 2.92 (1.31-6.54)] remained significant. The area under the curve of the risk prediction model utilizing HLA-A∗11:01:01:01, age at diagnosis, and sex at birth was 0.772, with sensitivity of 0.715 and specificity of 0.717. To the best of our knowledge, this is the first article which describes associations of HLA alleles with COVID-19 at the 4-field (highest) resolution level. Early identification of potential COVID-19 could help clinicians prioritize medical utility and significantly decrease mortality from COVID-19.
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Despite the increase in COVID-19 cases globally, the number of cases in Japan has been relatively low, and an explosive surge in the prevalence has not occurred. In March 2020, the Ministry of Health, Labour and Welfare (MHLW) in Japan recommended the original criteria for polymerase chain reaction (PCR) testing, although there was a lack of evidence for appropriate targets for COVID-19 testing. This study aimed to evaluate the COVID-19 positive ratio and pre-screening criteria in Tokyo immediately after the insurance-covered SARS-CoV-2 PCR testing became available in Japan. We subjected 277 individuals with mild symptoms in metropolitan Tokyo (positive: 9.0%) from March 9 to 29, 2020, to SARS-CoV-2 PCR testing. The results revealed that 25 (9.0%) of them were PCR-positive. The sensitivity and specificity of the MHLW criteria were 100% and 10.7%, respectively. When the criteria excluded nonspecific symptoms, fatigue, and dyspnea, the sensitivity slightly decreased to 92%, and the specificity increased to 22.2%. The specificity was highest when the fever criterion was >= 37.5 degrees C for >= 4 days, and exposure/travel history, including age and underlying comorbidities, was considered. Our findings suggest that the MHLW criteria, including the symptoms and exposure/travel history, may be useful for COVID-19 pre-screening.
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Background: Early detection of coronavirus disease (COVID-19) in patients likely to develop severe manifestations enables appropriate interventions, including rapid intensive care unit admission. This study was conducted to determine whether noninvasive urine biomarkers can predict the clinical severity of COVID-19. Methods: Design A retrospective case series. Setting Single-center study, national center hospital designated for infectious disease. Patients Fifty-eight patients who tested positive for SARS-CoV-2 in respiratory specimens through real-time reverse transcription-polymerase chain reaction (RT-PCR) were retrospectively studied. Measurements and main results Urinary β2-microglobulin (β2MG), liver-type fatty acid-binding protein (L-FABP) were serially measured. Serum interferon γ and monocyte chemotactic protein-1 were also evaluated. Results: The 58 patients were assigned into three groups. Patients requiring intensive care were assigned to the severe group (N = 12). Patients treated with oxygen were assigned to the moderate group (N = 13). Other patients were assigned to the mild group (N = 33). Urine tests revealed that low β2MG and L-FABP levels on admission were associated with mild disease, whereas high levels were associated with severe disease. In severe cases, L-FABP tended to be persistently high. The resulting cutoff values were β2MG;Severe vs. Moderate+Mild: 2457 μg/dL (Specificity 76.9% and Sensitivity 90.0%, AUC 85.9%), L-FABP;Severe vs. Moderate+Mild: 22.0 μg/gCre (Specificity 84.6% and Sensitivity 90%, AUC 91.8%). Urinary β2MG and serum IFN-γ/MCP-1 showed a similar trend. Conclusions: Evaluating urinary biomarkers such as β2MG and L-FABP may allow determination of COVID-19 patients with active cytokines and recognition of patients likely to become critically ill and requiring careful observation and early intervention.
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We analysed associations between exposure to nightlife businesses and severe acute respiratory syndrome coronavirus 2 PCR test results at a tertiary hospital in Tokyo between March and April 2020. A nightlife group was defined as those who had worked at or visited the businesses. We included 1517 individuals; 196 (12.9%) were categorised as the nightlife group. After propensity score matching, the proportion of positive PCR tests in the nightlife group was significantly higher than that in the non-nightlife group (nightlife, 63.8%; non-nightlife, 23.0%; P < 0.001). An inclusive approach to mitigate risks related to the businesses needs to be identified.