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1.
《Médecine et maladies infectieuses》2020,50(5):436-439
BackgroundMedical publications about anosmia with COVID-19 are scarce. We aimed to describe the prevalence and features of anosmia in COVID-19 patients.MethodsWe retrospectively included COVID-19 patients with anosmia between March 1st and March 17th, 2020. We used SARS-CoV-2 real time PCR in respiratory samples to confirm the cases.ResultsFifty-four of 114 patients (47%) with confirmed COVID-19 reported anosmia. Mean age of the 54 patients was 47 (± 16) years; 67% were females and 37% were hospitalised. The median Charlson comorbidity index was 0.70 (± 1.6 [0–7]). Forty-six patients (85%) had dysgeusia and 28% presented with pneumonia. Anosmia began 4.4 (± 1.9 [1–8]) days after infection onset. The mean duration of anosmia was 8.9 (± 6.3 [1–21]) days and 98% of patients recovered within 28 days.ConclusionsAnosmia was present in half of our European COVID-19 patients and was often associated with dysgeusia. 相似文献
2.
《Disability and health journal》2023,16(2):101436
BackgroundAdults with disabilities are at increased risk for SARS-CoV-2 infection and severe disease; whether adults with disabilities are at an increased risk for ongoing symptoms after acute SARS-CoV-2 infection is unknown.ObjectivesTo estimate the frequency and duration of long-term symptoms (>4 weeks) and health care utilization among adults with and without disabilities who self-report positive or negative SARS-CoV-2 test results.MethodsData from a nationwide survey of 4510 U.S. adults administered from September 24, 2021–October 7, 2021, were analyzed for 3251 (79%) participants who self-reported disability status, symptom(s), and SARS-CoV-2 test results (a positive test or only negative tests). Multivariable models were used to estimate the odds of having ≥1 COVID-19–like symptom(s) lasting >4 weeks by test result and disability status, weighted and adjusted for socio-demographics.ResultsRespondents who tested positive for SARS-CoV-2 had higher odds of reporting ≥1 long-term symptom (with disability: aOR = 4.50 [95% CI: 2.37, 8.54] and without disability: aOR = 9.88 [95% CI: 7.13, 13.71]) compared to respondents testing negative. Among respondents who tested positive, those with disabilities were not significantly more likely to experience long-term symptoms compared to respondents without disabilities (aOR = 1.65 [95% CI: 0.78, 3.50]). Health care utilization for reported symptoms was higher among respondents with disabilities who tested positive (40%) than among respondents without disabilities who tested positive (18%).ConclusionsOngoing symptoms among adults with and without disabilities who also test positive for SARS-CoV-2 are common; however, the frequency of health care utilization for ongoing symptoms is two-fold among adults with disabilities. 相似文献
3.
《Vaccine》2022,40(52):7653-7659
BackgroundRisk of experiencing a systemic adverse event (AE) after mRNA coronavirus disease 2019 (COVID-19) vaccination may be greater among persons with a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection; data on serious events are limited. We assessed if adults reporting systemic AEs resulting in emergency department visits or hospitalizations during days 0–7 after mRNA COVID-19 vaccine dose 1 were more likely to have a history of prior SARS-CoV-2 infection compared with persons who reported no or non-severe systemic AEs.MethodsWe conducted a nested case-control study using v-safe surveillance data. Participants were ≥ 18 years and received dose 1 during December 14, 2020─May 9, 2021. Cases reported severe systemic AEs 0–7 days after vaccination. Three controls were frequency matched per case by age, vaccination date, and days since vaccination. Follow-up surveys collected SARS-CoV-2 histories.ResultsFollow-up survey response rates were 38.6 % (potential cases) and 56.8 % (potential controls). In multivariable analyses including 3,862 case-patients and 11,586 controls, the odds of experiencing a severe systemic AE were 2.4 (Moderna, mRNA-1273; 95 % confidence interval [CI]: 1.89, 3.09) and 1.5 (Pfizer-BioNTech, BNT162b2; 95 % CI: 1.17, 2.02) times higher among participants with pre-vaccination SARS-CoV-2 histories compared with those without. Medical attention of any kind for symptoms during days 0–7 following dose 2 was not common among case-patients or controls.ConclusionsHistory of SARS-CoV-2 infection was significantly associated with severe systemic AEs following dose 1 of mRNA COVID-19 vaccine; the effect varied by vaccine received. Most participants who experienced severe systemic AEs following dose 1 did not require medical attention of any kind for symptoms following dose 2. Vaccine providers can use these findings to counsel patients who had pre-vaccination SARS-CoV-2 infection histories, experienced severe systemic AEs following dose 1, and are considering not receiving additional mRNA COVID-19 vaccine doses. 相似文献
4.
《Vaccine》2022,40(48):6979-6986
BackgroundTest-negative design (TND) studies have produced validated estimates of vaccine effectiveness (VE) for influenza vaccine studies. However, syndrome-negative controls have been proposed for differentiating bias and true estimates in VE evaluations for COVID-19. To understand the use of alternative control groups, we compared characteristics and VE estimates of syndrome-negative and test-negative VE controls.MethodsAdults hospitalized at 21 medical centers in 18 states March 11–August 31, 2021 were eligible for analysis. Case patients had symptomatic acute respiratory infection (ARI) and tested positive for SARS-CoV-2. Control groups were test-negative patients with ARI but negative SARS-CoV-2 testing, and syndrome-negative controls were without ARI and negative SARS-CoV-2 testing. Chi square and Wilcoxon rank sum tests were used to detect differences in baseline characteristics. VE against COVID-19 hospitalization was calculated using logistic regression comparing adjusted odds of prior mRNA vaccination between cases hospitalized with COVID-19 and each control group.Results5811 adults (2726 cases, 1696 test-negative controls, and 1389 syndrome-negative controls) were included. Control groups differed across characteristics including age, race/ethnicity, employment, previous hospitalizations, medical conditions, and immunosuppression. However, control-group-specific VE estimates were very similar. Among immunocompetent patients aged 18–64 years, VE was 93 % (95 % CI: 90–94) using syndrome-negative controls and 91 % (95 % CI: 88–93) using test-negative controls.ConclusionsDespite demographic and clinical differences between control groups, the use of either control group produced similar VE estimates across age groups and immunosuppression status. These findings support the use of test-negative controls and increase confidence in COVID-19 VE estimates produced by test-negative design studies. 相似文献
5.
《Vaccine》2022,40(15):2251-2257
BackgroundWith COVID-19 vaccine roll-out ongoing in many countries globally, monitoring of breakthrough infections is of great importance. Antibodies persist in the blood after a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Since COVID-19 vaccines induce immune response to the Spike protein of the virus, which is the main serosurveillance target to date, alternative targets should be explored to distinguish infection from vaccination.MethodsMultiplex immunoassay data from 1,513 SARS-CoV-2 RT-qPCR-tested individuals (352 positive and 1,161 negative) without COVID-19 vaccination history were used to determine the accuracy of Nucleoprotein-specific immunoglobulin G (IgG) in detecting past SARS-CoV-2 infection. We also described Spike S1 and Nucleoprotein-specific IgG responses in 230 COVID-19 vaccinated individuals (Pfizer/BioNTech).ResultsThe sensitivity of Nucleoprotein seropositivity was 85% (95% confidence interval: 80–90%) for mild COVID-19 in the first two months following symptom onset. Sensitivity was lower in asymptomatic individuals (67%, 50–81%). Participants who had experienced a SARS-CoV-2 infection up to 11 months preceding vaccination, as assessed by Spike S1 seropositivity or RT-qPCR, produced 2.7-fold higher median levels of IgG to Spike S1 ≥ 14 days after the first dose as compared to those unexposed to SARS-CoV-2 at ≥ 7 days after the second dose (p = 0.011). Nucleoprotein-specific IgG concentrations were not affected by vaccination in infection-naïve participants.ConclusionsSerological responses to Nucleoprotein may prove helpful in identifying SARS-CoV-2 infections after vaccination. Furthermore, it can help interpret IgG to Spike S1 after COVID-19 vaccination as particularly high responses shortly after vaccination could be explained by prior exposure history. 相似文献
6.
《Vaccine》2022,40(32):4603-4608
IntroductionThe safety of BCG revaccination is uncertain and there is no data on its use in patients with COVID-19.MethodsCOVID-19 convalescent adults confirmed by SARS-CoV-2 RT-PCR in South-America were 1:1 randomized in the first 14 days of symptoms to BCG intradermal vaccine or placebo and evaluated for adverse events on days 7, 14, 21, and beyond 40 days. Clinical Trial Registration: NCT04369794.Results151 placebo and 148 BCG patients were included in the final analysis, with an average age of 40.7 years. No severe adverse event to BCG was reported. On day 7, 130 (87.8%) of the BCG recipients had local reaction, average size of 10.6 ± 6.4 mm, compared to only 2 (1.3%) placebos. Lesions gradually shrunk in size (mean 10.5 mm, 9.7 mm, and 6.8 mm at 14, 21, and beyond 40 days, respectively. The number of symptoms in any of the visits was not different between groups, and anosmia resolved earlier (25.7% vs. 37.1% at 7 days, OR = 1.70, 1.01–2.89, p = 0.035) in the BCG recipients.ConclusionThe BCG revaccination is safe in convalescent COVID-19 adults of a tuberculosis endemic region, regardless of tuberculin or IGRA test results. Local adverse events were similar though occurred earlier to that previously reported in children. 相似文献
7.
Thomas Scheier Adrian Schibli Geri Eich Christian Rüegg Frank Kube Adrian Schmid Urs Karrer Aline Wolfensberger Hugo Sax Peter W. Schreiber 《Emerging infectious diseases》2021,27(2):404
Switzerland began a national lockdown on March 16, 2020, in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We assessed the prevalence of SARS-CoV-2 infection among patients admitted to 4 hospitals in the canton of Zurich, Switzerland, in April 2020. These 4 acute care hospitals screened 2,807 patients, including 2,278 (81.2%) who did not have symptoms of coronavirus disease (COVID-19). Overall, 529 (18.8%) persons had >1 symptom of COVID-19, of whom 60 (11.3%) tested positive for SARS-CoV-2. Eight asymptomatic persons (0.4%) also tested positive for SARS-CoV-2. Our findings indicate that screening on the basis of COVID-19 symptoms, regardless of clinical suspicion, can identify most SARS-CoV-2–positive persons in a low-prevalence setting. 相似文献
8.
《Disability and health journal》2021,14(4):101127
BackgroundEvidence regarding the risk of coronavirus disease (COVID-19) and the major adverse clinical outcomes of COVID-19 among people with disabilities (PwDs) is scarce.ObjectiveThis study investigated the association of disability status with the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positivity and the risk of major adverse clinical outcomes among participants who tested positive for SARS-CoV-2.MethodsThis study included all patients (n = 8070) who tested positive for SARS-CoV-2 and individuals without COVID-19 (n = 121,050) in South Korea from January 1 to May 30, 2020. The study variables included officially registered disability status from the government, SARS-CoV-2 test positivity, and major adverse clinical outcomes of COVID-19 (admission to the intensive care unit, invasive ventilation, or death).ResultsThe study participants included 129,120 individuals (including 7261 PwDs), of whom 8070 (6.3%) tested positive for SARS-CoV-2. After adjusting for potential confounding factors, PwDs had an increased risk of SARS-CoV-2 test positivity compared with people without disabilities (odds ratio [OR]: 1.36, 95% confidence interval [CI]: 1.24–1.48). Among participants who tested positive for SARS-CoV-2, PwDs were associated with an increased risk of major adverse clinical outcomes from COVID-19 compared to those without disabilities (OR: 1.43, 95% CI: 1.11–1.86).ConclusionsPwDs had an increased risk of COVID-19 and major adverse clinical outcomes of COVID-19 compared with people without disabilities. Given the higher vulnerability of PwDs to COVID-19, tailored policy and management to protect against the risk of COVID-19 are required. 相似文献
9.
《Journal of the American Medical Directors Association》2023,24(1):10-16
ObjectiveWe examined the impact of loss of skeletal muscle mass in post-acute sequelae of SARS-CoV-2 infection, hospital readmission rate, self-perception of health, and health care costs in a cohort of COVID-19 survivors.DesignProspective observational study.Setting and ParticipantsTertiary Clinical Hospital. Eighty COVID-19 survivors age 59 ± 14 years were prospectively assessed.MethodsHandgrip strength and vastus lateralis muscle cross-sectional area were evaluated at hospital admission, discharge, and 6 months after discharge. Post-acute sequelae of SARS-CoV-2 were evaluated 6 months after discharge (main outcome). Also, health care costs, hospital readmission rate, and self-perception of health were evaluated 2 and 6 months after hospital discharge. To examine whether the magnitude of muscle mass loss impacts the outcomes, we ranked patients according to relative vastus lateralis muscle cross-sectional area reduction during hospital stay into either “high muscle loss” (?18 ± 11%) or “low muscle loss” (?4 ± 2%) group, based on median values.ResultsHigh muscle loss group showed greater prevalence of fatigue (76% vs 46%, P = .0337) and myalgia (66% vs 36%, P = .0388), and lower muscle mass (?8% vs 3%, P < .0001) than low muscle loss group 6 months after discharge. No between-group difference was observed for hospital readmission and self-perceived health (P > .05). High muscle loss group demonstrated greater total COVID-19-related health care costs 2 ($77,283.87 vs. $3057.14, P = .0223, respectively) and 6 months ($90,001.35 vs $12, 913.27, P = .0210, respectively) after discharge vs low muscle loss group. Muscle mass loss was shown to be a predictor of total COVID-19-related health care costs at 2 (adjusted β = $10, 070.81, P < .0001) and 6 months after discharge (adjusted β = $9885.63, P < .0001).Conclusions and ImplicationsCOVID-19 survivors experiencing high muscle mass loss during hospital stay fail to fully recover muscle health. In addition, greater muscle loss was associated with a higher frequency of post-acute sequelae of SARS-CoV-2 and greater total COVID-19-related health care costs 2 and 6 months after discharge. Altogether, these data suggest that the loss of muscle mass resulting from COVID-19 hospitalization may incur in an economical burden to health care systems. 相似文献
10.
《Vaccine》2021,39(36):5087-5090
IntroductionCOVID-19 vaccination seems to be the most pertinent pharmacologic public health measure to control the pandemic. Reactogenicity symptoms were frequent in vaccine recipients mostly mild to moderate and commonly reported after the second dose. However, there is a lack of data in patients with a previous diagnosis of Covid-19.MethodsWe analysed side effects of 311 patients after the first dose of Pfizer-BioNTech COVID-19 vaccine, in a french university hospital. We compared patients with COVID-19 history to naive individuals. All the data collected are based on self-reported, including COVID-19 exposure status.ResultsOverall, 229 (74%) patients reported at least one side effect. Among participants with history of Covid-19, 95% reported at least one adverse event versus 70% in naive patients (p < 0.01). However, symptom intensity was not different between the 2 groups.ConclusionVaccine recipients with prior COVID-19 reported more, but no more serious, side effects than naive participants. 相似文献
11.
《Journal of the American Medical Directors Association》2022,23(3):414-420.e1
ObjectiveStudies suggesting that vulnerability increased short-term mortality in older patients with COVID-19 enrolled hospitalized patients and lacked COVID-negative comparators. Aim of this study was to examine the relationship between frailty and 1-year mortality in older patients with and without COVID-19, hospitalized and nonhospitalized.DesignCohort study.Setting and ParticipantsPatients over 75 years old accessing the emergency departments (ED) were identified from the ED archives in Florence, Italy.MethodsVulnerability status was estimated with the Dynamic Silver Code (DSC). COVID-19 hospital discharges (HC+) were compared with non-COVID-19 discharges (HC-). Linkage with a national COVID-19 registry identified nonhospitalized ED visitors with (NHC+) or without COVID-19 (NHC-).ResultsIn 1 year, 48.4% and 33.9% of 1745 HC+ and 15,846 HC- participants died (P < .001). Mortality increased from 27.5% to 64.0% in HC+ and from 19.9% to 51.1% in HC- across DSC classes I to IV, with HC+ vs HC- hazard ratios between 1.6 and 2.2. Out of 1039 NHC+ and 18,722 NHC- participants, 18% and 8.7% died (P < .001). Mortality increased from 14.2% to 46.7% in NHC+ and from 2.9% to 26% in NHC- across DSC; NHC+ vs NHC- hazard ratios decreased from 5.3 in class I to 2.0 in class IV.Conclusions and ImplicationsIn hospitalized older patients, mortality increases with vulnerability similarly in the presence and in the absence of COVID-19. In nonhospitalized patients, vulnerability-associated excess mortality is milder in individuals with than in those without COVID-19. The disease reduces survival even when background risk is low. Thus, apparently uncomplicated patients deserve closer clinical monitoring than commonly applied. 相似文献
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13.
Debbie Ehrmann Feldman Marie-Hlne Boudrias Barbara Mazer 《Canadian journal of public health. Revue canadienne de santé publique》2022,113(6):930
ObjectivesThe impact of long COVID among persons hospitalized and discharged home is unknown. We aimed to (1) report the prevalence of long COVID in persons hospitalized for COVID-19 and discharged home; (2) estimate the prevalence of physical, sensory, and psychological/mental health impairments; and (3) explore associated factors.MethodsWe conducted a telephone survey of adult residents in Laval, Quebec, who were discharged home ≥ 2 months post-hospitalization for COVID-19. Participants responded to a standard questionnaire regarding persistent symptoms. We calculated the prevalence of long COVID and of persistent types of symptoms and evaluated associated factors using bivariate analysis and multivariable logistic regression.ResultsIn our sample (n = 398), 70% reported physical symptoms, 58% psychological problems, and 16% sensory impairments. 31.5% reported being troubled by persistent symptoms (long COVID). Factors associated with long COVID were a greater number of symptoms (odds ratio (OR) = 1.97, 95% confidence interval (CI) = 1.69–2.28) and increased hospital stay (OR = 1.03, 95% CI = 1.01–1.06). Other factors associated with physical and psychological symptoms were female sex (OR = 2.17, 95% CI = 1.27–3.71 and OR = 2.06, 95% CI = 1.25–3.39; respectively), higher education level (OR = 2.10, 95% CI = 1.20–3.68 and OR = 2.43, 95% CI = 1.44–4.14; respectively), and obesity (OR = 1.95, 95% CI = 1.15–3.34 and OR = 1.70, 95% CI = 1.05–2.77; respectively).ConclusionIn this population-based study of persons hospitalized for COVID-19 and discharged home, nearly one third were troubled by symptoms for 2 months or more post-discharge. There was a high proportion with persistent physical and psychological/mental health symptoms. Further research will assess the specific needs of these patients to inform health policy makers on service requirements for these persons. 相似文献
14.
《Vaccine》2023,41(1):193-200
IntroductionCoronavirus infection is a particular risk for patients with chronic obstructive pulmonary disease (COPD), because they are much more likely to become severely ill due to oxygen supply problems. Primary prevention, including COVID-19 vaccination is of paramount importance in this disease group. The aim of our study was to assess COVID-19 vaccination coverage in COPD patients during the first vaccination campaign of the COVID-19 pandemic.MethodsA cross-sectional observational study (CHANCE) has been conducted in COPD patients in the eastern, western and central regions of Hungary from 15th November 2021. The anthropometric, respiratory function test results and vaccination status of 1,511 randomly selected patients were recorded who were aged 35 years and older.ResultsThe median age was 67 (61–72) years, for men: 67 (62–73) and for women: 66 (60–72) years, with 47.98 % men and 52.02 % women in our sample. The prevalence of vaccination coverage for the first COVID-19 vaccine dose was 88.62 %, whereas 86.57 % of the patients received the second vaccine dose. When unvaccinated (n = 172) and double vaccinated (n = 1308) patients were compared, the difference was significant both in quality of life (CAT: 17 (12–23) vs 14 (10–19); p < 0.001) and severity of dyspnea (mMRC: 2 (2–2) vs 2 (1–2); p = 0.048). The COVID-19 infection rate between double vaccinated and unvaccinated patients was 1.61 % vs 22.67 %; p < 0.001 six months after vaccination. The difference between unvaccinated and vaccinated patients was significant (8.14 % vs 0.08 %; p < 0.001) among those with acute COVID-19 infection hospitalized. In terms of post-COVID symptoms, single or double vaccinated patients had significantly fewer outpatient hospital admissions than unvaccinated patients (7.56 vs 0 %; p < 0.001).ConclusionThe COVID-19 vaccination coverage was satisfactory in our sample. The uptake of COVID-19 vaccines by patients with COPD is of utmost importance because they are much more likely to develop severe complications. 相似文献
15.
目的 探讨新型冠状病毒(SARS-CoV-2)核酸检测在发热门诊、隔离病房、易感人群以及大规模筛查等不同人群中的应用价值,为SARS-CoV-2实验室检测提供参考依据。方法 采集2020年2月1日-3月22日郑州人民医院不同人群的咽拭子,包括发热门诊、隔离病房患者,一线疫情防控医护人员,以及无新型冠状病毒肺炎(COVID-19)症状的住院患者、陪护家属和复工人员。采用逆转录聚合酶链反应(RT-PCR)方法,使用A、B两种国产检测试剂盒对发热门诊、隔离病房的患者进行SARS-CoV-2核酸检测。结果 共检测15 497份咽拭子标本,SARS-CoV-2核酸阳性24份,核酸阳性病例均来自发热门诊和隔离病房。24例咽拭子SARS-CoV-2核酸阳性患者同时送检的血标本核酸结果均呈阴性。A、B两种试剂首次咽拭子核酸检测结果一致,2例确诊COVID-19患者治疗后复查咽拭子标本,A组试剂检测为阳性,B组试剂检测为阴性。该院疫情防控一线医护人员、未出现COVID-19症状的住院患者、陪护家属和复工体检人员核酸检测均为阴性。结论 复工人员、住院患者、陪护家属和一线疫情防控人员SARS-CoV-2核酸筛查均未发现阳性,咽拭子标本SARS-CoV-2核酸检测阳性率高于血标本,不同核酸检测试剂检测阳性率稍有差异。 相似文献
16.
《Vaccine》2021,39(27):3602-3607
BackgroundAlthough vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the most desired solution to end the coronavirus disease (COVID-19) pandemic, there are growing concerns that vaccine hesitancy would undermine its potential. We examined the intention to receive vaccination against SARS-CoV-2 and the associated factors in a representative sample of Chinese adults in Hong Kong.MethodsWe did a dual-frame (landline and mobile) cross-sectional survey of a random sample of 1501 Hong Kong residents aged 18 years or older (53.6% females) in April 2020. We collected data on the intention to receive SARS-CoV-2 vaccine when it becomes available (yes/ no/ undecided), knowledge and perceptions of COVID-19, smoking, alcohol drinking, and sociodemographic factors. Prevalence estimates were weighted by the sex, age, and education of the general population of Hong Kong.ResultsOverall, 45.3% (95% CI: 42.3–48.4%) of the participants had intentions to vaccinate against SARS-CoV-2 when it becomes available, 29.2% (26.5–32.1%) were undecided, and 25.5% (22.9–28.2%) had no intention. The most common reason for vaccine hesitancy (undecided or no intention) was safety concerns (56.5%). Multivariable partial proportional odds model showed higher vaccine hesitancy in males, younger adults, those with no chronic disease, current smokers, and non-alcohol drinkers. After adjusting for sociodemographic and other factors, inadequate knowledge of SARS-CoV-2 transmission (adjusted ORs ranged from 1.27 to 2.63; P < 0.05) and lower perceived danger of COVID-19 (adjusted ORs ranged from 1.62 to 2.47; P < 0.001) were significantly associated with vaccine hesitancy.ConclusionsIn a representative sample of Chinese adults in Hong Kong, only 45.3% of the participants intended to vaccinate against SARS-CoV-2 when available. Vaccine hesitancy was associated with inadequate knowledge about SARS-CoV-2 transmission and lower perceived danger of COVID-19, which needed to be addressed to improve vaccination uptake. 相似文献
17.
《Vaccine》2021,39(44):6520-6528
BackgroundThe WHO declared COVID-19 a pandemic on March 11th, 2020. This serious outbreak and the precipitously increasing numbers of deaths worldwide necessitated the urgent need to develop an effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. The development of COVID-19 vaccines has moved quickly. In this study, we assessed the efficacy, safety, and immunogenicity of an inactivated (SARS-CoV-2) vaccine.MethodsWe conducted a randomized, double-blind, placebo-controlled trial to evaluate the efficacy, immunogenicity, and safety of an inactivated SARS-CoV-2 vaccine and its lot-to-lot consistency. A total of 1620 healthy adults aged 18–59 years were randomly assigned to receive 2 injections of the trial vaccine or placebo on a day 0 and 14 schedule. This article was based on an interim report completed within 3 months following the last dose of study vaccine. The interim analysis includes safety and immunogenicity data for 540 participants in the immunogenicity subset and an efficacy analysis of the 1620 subjects. For the safety evaluation, solicited and unsolicited adverse events were collected after the first and second vaccination within 14 and 28 days, respectively. Blood samples were collected for an antibody assay before and 14 days following the second dose.ResultsMost of the adverse reactions were in the solicited category and were mild in severity. Pain at the injection site was the most frequently reported symptom. Antibody IgG titer determined by enzyme-linked immunosorbent assay was 97.48% for the seroconversion rate. Using a neutralization assay, the seroconversion rate was 87.15%. The efficacy in preventing symptomatic confirmed cases of COVID-19 occurring at least 14 days after the second dose of vaccine using an incidence rate was 65.30%.ConclusionsFrom the 3-month interim analysis, the vaccine exhibited a 65.30% efficacy at preventing COVID-19 illness with favorable safety and immunogenicity profiles. 相似文献
18.
《Vaccine》2023,41(29):4249-4256
BackgroundAccurate determination of COVID-19 vaccination status is necessary to produce reliable COVID-19 vaccine effectiveness (VE) estimates. Data comparing differences in COVID-19 VE by vaccination sources (i.e., immunization information systems [IIS], electronic medical records [EMR], and self-report) are limited. We compared the number of mRNA COVID-19 vaccine doses identified by each of these sources to assess agreement as well as differences in VE estimates using vaccination data from each individual source and vaccination data adjudicated from all sources combined.MethodsAdults aged ≥18 years who were hospitalized with COVID-like illness at 21 hospitals in 18 U.S. states participating in the IVY Network during February 1–August 31, 2022, were enrolled. Numbers of COVID-19 vaccine doses identified by IIS, EMR, and self-report were compared in kappa agreement analyses. Effectiveness of mRNA COVID-19 vaccines against COVID-19-associated hospitalization was estimated using multivariable logistic regression models to compare the odds of COVID-19 vaccination between SARS-CoV-2-positive case-patients and SARS-CoV-2-negative control-patients. VE was estimated using each source of vaccination data separately and all sources combined.ResultsA total of 4499 patients were included. Patients with ≥1 mRNA COVID-19 vaccine dose were identified most frequently by self-report (n = 3570, 79 %), followed by IIS (n = 3272, 73 %) and EMR (n = 3057, 68 %). Agreement was highest between IIS and self-report for 4 doses with a kappa of 0.77 (95 % CI = 0.73–0.81). VE point estimates of 3 doses against COVID-19 hospitalization were substantially lower when using vaccination data from EMR only (VE = 31 %, 95 % CI = 16 %–43 %) than when using all sources combined (VE = 53 %, 95 % CI = 41 %–62%).ConclusionVaccination data from EMR only may substantially underestimate COVID-19 VE. 相似文献
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《Journal of the American Medical Directors Association》2020,21(7):895-899.e1
ObjectivesMany nursing home residents infected with SARS-CoV-2 fail to be identified with standard screening for the associated COVID-19 syndrome. Current nursing home COVID-19 screening guidance includes assessment for fever, defined as a temperature of at least 38.0°C. The objective of this study was to describe the temperature changes before and after universal testing for SARS-CoV-2 in nursing home residents.DesignCohort study.Setting and ParticipantsThe Veterans Administration (VA) operates 134 Community Living Centers (CLC), similar to nursing homes, that house residents who cannot live independently. VA guidance to CLCs directed daily clinical screening for COVID-19 that included temperature assessment.MeasuresAll CLC residents (n = 7325) underwent SARS-CoV-2 testing. We report the temperature in the window of 14 days before and after universal SARS-CoV-2 testing among CLC residents. Baseline temperature was calculated for 5 days before the study window.ResultsSARS-CoV-2 was identified in 443 (6.0%) residents. The average maximum temperature in SARS-CoV-2–positive residents was 37.66 (0.69) compared with 37.11 (0.36) (P = .001) in SARS-CoV-2–negative residents. Temperatures in those with SARS-CoV-2 began rising 7 days before testing and remained elevated during the 14-day follow-up. Among SARS-CoV-2–positive residents, only 26.6% (n = 118) met the fever threshold of 38.0°C during the survey period. Most residents (62.5%, n = 277) with confirmed SARS-CoV-2 did experience 2 or more 0.5°C elevations above their baseline values. One cohort of SARS-CoV-2 residents' (20.3%, n = 90) temperatures never deviated >0.5°C from baseline.Conclusions and ImplicationsA single screening for temperature is unlikely to detect nursing home residents with SARS-CoV-2. Repeated temperature measurement with a patient-derived baseline can increase sensitivity. The current fever threshold as a screening criteria for SARS-CoV-2 infection should be reconsidered. 相似文献