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1.
J Infect Dis ; 2022 Jul 25.
Article in English | MEDLINE | ID: covidwho-1961056

ABSTRACT

Detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is essential for diagnosis, treatment, and infection control. Polymerase chain reaction (PCR) fails to distinguish acute from resolved infections, as RNA is frequently detected after infectiousness. We hypothesized that nucleocapsid in blood marks acute infection with the potential to enhance isolation and treatment strategies. In a retrospective serosurvey of inpatient and outpatient encounters, we categorized samples along an infection timeline using timing of SARS-CoV-2 testing and symptomatology. Among 1860 specimens from 1607 patients, the highest levels and frequency of antigenemia were observed in samples from acute SARS-CoV-2 infection. Antigenemia was higher in seronegative individuals and in those with severe disease. In our analysis, antigenemia exhibited 85.8% sensitivity and 98.6% specificity as a biomarker for acute coronavirus disease 2019 (COVID-19). Thus, antigenemia sensitively and specifically marks acute SARS-CoV-2 infection. Further study is warranted to determine whether antigenemia may aid individualized assessment of active COVID-19.

2.
BJOG: An International Journal of Obstetrics and Gynaecology ; 129:114-115, 2022.
Article in English | EMBASE | ID: covidwho-1956652

ABSTRACT

Objective: To study the impact of national recommendations on the method of screening used for GDM during the COVID-19 pandemic, and evaluate differences in maternal and fetal outcomes among women with first-time GDM (ftGDM). Design: A retrospective observational study in a single Tertiary London Hospital. During the pandemic, the RCOG recommended an amended GDM screening protocol to reduce hospital attendance and risk of virus transmission (fasting blood glucose level ≥5.3 and/or HbA1c ≥39 at 28 weeks of gestation). Our Trust did not adopt this due to concerns regarding its sensitivity. We adopt a 2-step approach to universal GDM screening using a 50g glucose challenge test, and refer those screening positive for a full oral glucose tolerance test. Method: Outcomes were reviewed for women with ftGDM delivering a singleton at ≥24 weeks gestation between 01/04/20 -28/ 5/21. Our primary aim was to determine the impact of the change in COVID-19 GDM screening policy, had it been implemented. Our secondary outcomes included GDM management method, maternal and perinatal complications. We excluded women with a booking HbA1c ≥42 (indicative of pre-diabetes) and those who had bariatric surgery. Demographic and outcome data were obtained from electronic databases. Results: 247 women were diagnosed with ftGDM using local screening methods. Only 23 of these women had a HbA1c ≥39 at time of diagnosis and a further 12 had FBG ≥5.3. There was no significant difference in age or ethnicity between the two groups. The locally diagnosed group had a statistically significantly lower booking BMI (P<0.001) and were less likely to require pharmacological management of GDM (P<0.001). There were no significant differences in rates of induction of labour, gestation at delivery, birth weight or any perinatal adverse outcome. However, the women in the Covid-19 GDM screening group were significantly more likely to be delivered by Emergency Caesarean Section (p = 0.03) and have gestational hypertensive disease (p = 0.025). Conclusions: If we had implemented RCOG HbA1c screening, we would have not diagnosed 207 women with GDM, 41% of whom required pharmacological treatment. It is not surprising that women with higher HbA1c values had higher rates of maternal complications, due to the well-established association between maternal hyperglycaemia and adverse obstetric outcomes. As such, it is imperative that more sensitive screening protocols such as the 50g screen are considered in any future pandemics, such that women with GDM can be identified and maternal hyperglycaemia treated to benefit in-utero fetal programming.

3.
American Journal of Respiratory and Critical Care Medicine ; 205(1), 2022.
Article in English | EMBASE | ID: covidwho-1927811

ABSTRACT

Rationale: Burnout and distress amongst ICU staff are prevalent and have been exacerbated during the COVID-19 pandemic. In this context, recent data have revealed an increased incidence of adverse mental health events (AMHE) amongst healthcare workers (HCW). However, identifying HCWs at risk for AMHE and offering timely support services remains a challenge. Our aim is to develop a telehealth-based platform to provide mental health screening and tailored interventions to ICU HCW at an academic medical center. Methods: A multidisciplinary team comprised of clinical and behavioral psychologists, resiliency coordinators, pulmonary critical care fellows, and faculty iteratively developed a screening questionnaire using validated tools directed at various domains of mental health including sleep disturbance, depression, anxiety, PTSD, resiliency, alcohol misuse, and burnout. Using Research Electronic Data Capture (REDCap) with an integrated Twilio platform, we developed a text-based, interactive tool designed to 1) screen HCWs for AMHE, 2) communicate results to respondents in real-time, and 3) provide risk-stratified referrals to support services such as a mental health practitioner or self-help mobile applications. We performed cognitive pretesting on the amalgamated survey instrument with 6 ICU HCW stakeholders including three ICU RNs, one RT, and two physicians. We sought feedback on survey length, concerns about confidentiality, likelihood to accept mental health referrals, and pertinence of the questions to ICU HCWs. Feedback was obtained via a 4-question survey and through qualitative field notes. Results: The mean duration required to complete the survey during beta-testing was 6.97 mins +/-2.46 mins (SD). 100% of participants reported that the questionnaire was ”not overly burdensome” (5/6) or “minimally burdensome” (1/6). Participants were also “very confident” (4/6) or “confident” (2/6) their confidentiality would be maintained with this intervention. 83% (5/6) of participants stated that they were either “extremely likely” (3/6) or “likely” (2/6) to accept real-time feedback including a mental health referral if their responses suggest possible mental health distress. Only 17% (1/6) reported that they are unlikely to accept a mental health referral. All participants rated the pertinence of the questions to the healthcare workers to be high with 33% (2/6) characterizing the pertinence as excellent and 67% (4/6) as very good. Illustrative comments from the qualitative assessment are included in the Table. Conclusion: A telehealth-based platform for a mental health screening with real-time feedback and support service referral is feasible and was well-received by ICU HCW during cognitive pretesting.

4.
International Journal of Emerging Markets ; 2022.
Article in English | Scopus | ID: covidwho-1922502

ABSTRACT

Purpose: This article aims to uncover the impact of Google Trends on cryptocurrency markets beyond Bitcoin during the time of increased attention to altcoins, especially during the COVID-19 pandemic. Design/methodology/approach: This paper analyses the nexus among the Google Trends and six cryptocurrencies, namely Bitcoin, New Economy Movement (NEM), Dash, Ethereum, Ripple and Litecoin by utilizing the causality-in-quantiles technique on data comprised of the years January 2016–March 2021. Findings: The findings show that Google Trends cause the Litecoin, Bitcoin, Ripple, Ethereum and NEM prices at majority of the quantiles except for Dash. Originality/value: The findings will help investors to develop more in-depth understanding of impact of Google Trends on cryptocurrency prices and build successful trading strategies in a more matured digital assets ecosystem. © 2022, Emerald Publishing Limited.

5.
JOURNAL OF THE PAKISTAN MEDICAL ASSOCIATION ; 72(7):1391-1395, 2022.
Article in English | Web of Science | ID: covidwho-1912783

ABSTRACT

Objective:To determine clinical characteristics, obstetrics and perinatal outcome of coronavirus disease 2019 infection in pregnant women. Method:The cross-sectional study was conducted at the Department of Obstetrics and Gynaecology of the Ruth Pfau Civil Hospital, Karachi, and Dow University of Health Sciences, Karachi, from August 2020 to July 2021, and comprised pregnant women with suspicion of coronavirus disease 2019 infection, who underwent recommended testing, and were found to be positive. Oral swabs for the presence of infection were also taken from the neonate within 24 hours of delivery. Data was analysed using Stata 11. Results:There were 41 women with a mean age of 27 +/- 5 years, a mean gestational age of 35 +/- 3 weeks, and mean parity 1.2 +/- 1.01. Of them, 3(7.3%) women died. Medical complications found along with coronavirus disease 2019 infection were pregnancy-induced hypertension 2(4.8%), eclampsia 4(11%) and diabetes mellitus 2(4.8%). Fever was the most common symptom seen in 12(30%) women, followed by cough 7(20%) and shortness of breath 6(14%). Majority 32(82%) of the women underwent caesarean section. The most common maternal complication was postpartum haemorrhage 6(20%). Also, 36(86%) women required intensive care unit stay for a mean 5 +/- 9 days. Conclusion:Fever, followed by cough and breathlessness, were the most common clinical features. Most common maternal and foetal complication was postpartum haemorrhage and low birth weight, respectively.

6.
BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY ; 129:116-117, 2022.
Article in English | Web of Science | ID: covidwho-1905378
7.
BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY ; 129:69-70, 2022.
Article in English | Web of Science | ID: covidwho-1904584
8.
BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY ; 129:152-152, 2022.
Article in English | Web of Science | ID: covidwho-1904441
9.
Pharmaceutical and Biomedical Research ; 6(SpecialIssue1):45-48, 2020.
Article in English | EMBASE | ID: covidwho-1884826

ABSTRACT

Background: The COVID-19 pandemic has been followed by the shutting down of bars and liquor shops. This condition has led to the acute unavailability of alcohol, and subsequently increasing the number of cases of alcohol withdrawal. Objectives: This paper reports the clinical profile of cases of alcohol withdrawal presented to the psychiatry department following the non-availability of alcohol due to the COVID-19 lockdown. Methods: The patients were referred to the psychiatry department from the emergency medicine department and some of them directly to the psychiatry department. Thirty-two patients with alcohol use disorder and alcohol withdrawal were included in the study. The study data were collected using a semi-structured proforma and then were tabulated. The obtained data were assessed by the Chi-square test and unpaired t-test where appropriate. Results: The Mean±SD age of the study patients were 38.84±11.64 years. The Mean±SD years of consumption of alcohol was 13.50±7.8 years in the sample (range 1-30 years) and Mean±SD days of last consumption of alcohol was 3.88±1.8 days (range 2-10 days). There were no significant differences between stockers and non-stockers in various parameters. Conclusion: Alcohol and substance withdrawal have increased in the wake of the lockdown and COVID-19 pandemic and there is a need for non-COVID-19 setups to be created to cater to the needs of these patients.

11.
Dynamics of Continuous, Discrete and Impulsive Systems Series B: Applications and Algorithms ; 29(4):225-239, 2022.
Article in English | Scopus | ID: covidwho-1877338

ABSTRACT

During the COVID-19 pandemic, almost every sector has paid the price;from which the film industry cannot be excluded. As lockdown and social distancing were imposed during this phase, film industry was also being put on halt. Film industry restored restricted activities in unlock phase. This led to physical working instead of digital. During the shoot, the intensity of spread of COVID-19 among crew members advances through asymptomatic infected individuals. In response to ongoing situation in film industry, a mathematical model is designed. This model suggests that people work in film industry are at the high risk of COVID-19 exposure. Stability analysis along with bifurcation are observed to uphold the findings. © 2022 Watam Press.

12.
Clinical Cancer Research ; 27(6 SUPPL 1), 2021.
Article in English | EMBASE | ID: covidwho-1816884

ABSTRACT

The COVID-19 pandemic brought with it TX changes for many patients (pts) with AMEL, as it did for other pts with cancer. The long-term impacts of mandated area lockdowns, social distancing, medical society guidelines, and patient preference will not be fully understood for some time. The first step to learning from the pandemic is to assess how AMEL care was rendered in 2020. We performed a retrospective analysis of systemic TX for AMEL in KPNC, an integrated community healthcare system with approximately 4 million pts and about 150 de novo diagnoses of AMEL annually. We performed a chart review of pts with AMEL who were treated with standard of care systemic therapy, either immune-checkpoint inhibitors (ICI) or BRAF/MEK inhibitors (BRAF/MEKi), from January 1 to March 15, 2020, as a control group, and between March 15 and May 20, during the first wave of the COVID-19 pandemic in California with follow-up through November 4, 2020. Between January 1 and March 15, 26 pts started palliative ICI of whom 11 started combination PD1 (PD1i) and CTLA4 inhibitors. Among 15 pts who started on single-agent PD1i, 14 pts received short-interval TX (SIT), while 1 started long-interval TX (LIT). All 21 pts who started perioperative PD1i pre-pandemic, started on SIT. Between March 15 and May 20, 21 pts started palliative ICI, of whom only 3 started combination TX. Among pts who started palliative single-agent PD1i 40% started on LIT in this initial phase of the pandemic. 27 pts started perioperative ICI during this time. We found 3 started with neoadjuvant therapy and 78% started on LIT. Among 78 pts who were already on palliative single-agent ICI at the start of the COVID-19 pandemic, 15% remained on SIT and 24% changed to LIT. Sixteen pts (21%) also interrupted palliative ICI between March 15 and April 15 after a median time on TX of 45 weeks and for 63% the cited reason for interruption on chart review was the COVID 19 pandemic. Three of these pts who stopped ICI changed to BRAF/MEKi, the remainder continue in active follow-up as of November 2020. Among 72 pts already receiving perioperative ICI in March 2020, 19% remained on SIT, 35% changed to LIT, and 11% were already on LIT. 39% of pts interrupted perioperative ICI after a median time of 20 weeks on TX and 46% of these cited COVID 19 as the reason for interruption. Three pts have since resumed peri-operative TX, but the others remain in active follow-up off therapy. Between 3/15 and 5/30/2020, we noted a 325% increase in pts started on BRAF/MEKi;69% of pts received therapy for palliative intent. The start of the COVID-19 pandemic saw many different changes in AMEL TX in KPNC, with increased use of single-agent ICI, LIT, and oral therapy, in line with public health guidance, oncology societal guidelines and patient preference. It will be important to assess the long-term outcomes relating to these changes, including the impact of early discontinuation of ICI, to help guide future Melanoma care during and after the pandemic.

13.
Advanced Applications of Computational Mathematics ; : 245-263, 2021.
Article in English | Scopus | ID: covidwho-1801676

ABSTRACT

Different stages of unlocking have begun for COVID-19 pandemic in some parts of the world. Therefore, it becomes important to focus on inhibitory or psychological effects that help in controlling the spread of COVID-19 pandemic in the society. Considering this, we formulate a SEIQHR mathematical model representing COVID-19 scenario with an incidence function of two infectious classes, namely symptomatic and asymptomatic with the inhibitory effect. The model is said to exhibit two equilibria, namely diseasefree equilibrium (DFE) and endemic equilibrium (EE). Basic reproduction number is computed for the model. The local stability analysis is carried out for both the equilibria using Routh-Hurwitz criterion. The result shows stability of DFE when R0 < 1 and persistence of COVID-19 when R0 > 1. Sensitivity analysis of R0 is also studied to understand the effect of various parameters used in modeling the spread of COVID-19. At the end, numerical results have been studied for the formulated model, showing existence of various bifurcations. The largest Lyapunov exponent is also calculated, indicating complexity of the model with low inhibitory rates. © 2021 River Publishers.

14.
PubMed; 2020.
Preprint in English | PubMed | ID: ppcovidwho-333616

ABSTRACT

OBJECTIVE: Patients with autoimmune diseases were advised to shield to avoid COVID-19, but information on their prognosis is lacking. We characterised 30-day outcomes and mortality after hospitalisation with COVID-19 among patients with prevalent autoimmune diseases, and compared outcomes after hospital admissions among similar patients with seasonal influenza. DESIGN: Multinational network cohort study. SETTING: Electronic health records data from Columbia University Irving Medical Center (CUIMC) (NYC, United States [US]), Optum [US], Department of Veterans Affairs (VA) (US), Information System for Research in Primary Care-Hospitalisation Linked Data (SIDIAP-H) (Spain), and claims data from IQVIA Open Claims (US) and Health Insurance and Review Assessment (HIRA) (South Korea). PARTICIPANTS: All patients with prevalent autoimmune diseases, diagnosed and/or hospitalised between January and June 2020 with COVID-19, and similar patients hospitalised with influenza in 2017-2018 were included. MAIN OUTCOME MEASURES: 30-day complications during hospitalisation and death. RESULTS: We studied 133,589 patients diagnosed and 48,418 hospitalised with COVID-19 with prevalent autoimmune diseases. The majority of participants were female (60.5% to 65.9%) and aged >=50 years. The most prevalent autoimmune conditions were psoriasis (3.5 to 32.5%), rheumatoid arthritis (3.9 to 18.9%), and vasculitis (3.3 to 17.6%). Amongst hospitalised patients, Type 1 diabetes was the most common autoimmune condition (4.8% to 7.5%) in US databases, rheumatoid arthritis in HIRA (18.9%), and psoriasis in SIDIAP-H (26.4%). Compared to 70,660 hospitalised with influenza, those admitted with COVID-19 had more respiratory complications including pneumonia and acute respiratory distress syndrome, and higher 30-day mortality (2.2% to 4.3% versus 6.3% to 24.6%). CONCLUSIONS: Patients with autoimmune diseases had high rates of respiratory complications and 30-day mortality following a hospitalization with COVID-19. Compared to influenza, COVID-19 is a more severe disease, leading to more complications and higher mortality. Future studies should investigate predictors of poor outcomes in COVID-19 patients with autoimmune diseases. WHAT IS ALREADY KNOWN ABOUT THIS TOPIC: Patients with autoimmune conditions may be at increased risk of COVID-19 infection andcomplications. There is a paucity of evidence characterising the outcomes of hospitalised COVID-19 patients with prevalent autoimmune conditions. WHAT THIS STUDY ADDS: Most people with autoimmune diseases who required hospitalisation for COVID-19 were women, aged 50 years or older, and had substantial previous comorbidities.Patients who were hospitalised with COVID-19 and had prevalent autoimmune diseases had higher prevalence of hypertension, chronic kidney disease, heart disease, and Type 2 diabetes as compared to those with prevalent autoimmune diseases who were diagnosed with COVID-19.A variable proportion of 6% to 25% across data sources died within one month of hospitalisation with COVID-19 and prevalent autoimmune diseases.For people with autoimmune diseases, COVID-19 hospitalisation was associated with worse outcomes and 30-day mortality compared to admission with influenza in the 2017-2018 season.

15.
Open Forum Infect Dis ; 9(4): ofac101, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1774409

ABSTRACT

Background: We examined differences in mortality among coronavirus disease 2019 (COVID-19) cases in the first, second, and third waves of the COVID-19 pandemic. Methods: A retrospective cohort study of COVID-19 cases in Fulton County, Georgia, USA, reported to a public health surveillance from March 2020 through February 2021. We estimated case-fatality rates (CFR) by wave and used Cox proportional hazards random-effects models in each wave, with random effects at individual and long-term-care-facility level, to determine risk factors associated with rates of mortality. Results: Of 75 289 confirmed cases, 4490 (6%) were diagnosed in wave 1 (CFR 31 deaths/100 000 person days [pd]), 24 293 (32%) in wave 2 (CFR 7 deaths/100 000 pd), and 46 506 (62%) in wave 3 (CFR 9 deaths/100 000 pd). Compared with females, males were more likely to die in each wave: wave 1 (adjusted hazard ratio [aHR], 1.5; 95% confidence interval [CI], 1.2-1.8), wave 2 (aHR 1.5, 95% CI, 1.2-1.8), and wave 3 (aHR 1.7, 95% CI, 1.5-2.0). Compared with non-Hispanic whites, non-Hispanic blacks were more likely to die in each wave: wave 1 (aHR, 1.4; 95% CI, 1.1-1.8), wave 2 (aHR, 1.5; 95% CI, 1.2-1.9), and wave 3 (aHR, 1.7; 95% CI, 1.4-2.0). Cases with any disability, chronic renal disease, and cardiovascular disease were more likely to die in each wave compared with those without these comorbidities. Conclusions: Our study found gender and racial/ethnic disparities in COVID-19 mortality and certain comorbidities associated with COVID-19 mortality. These factors have persisted throughout the COVID-19 pandemic waves, despite improvements in diagnosis and treatment.

16.
Osteoarthritis and Cartilage ; 30:S72-S73, 2022.
Article in English | EMBASE | ID: covidwho-1768335

ABSTRACT

Purpose: Current walking interventions for people with knee osteoarthritis (OA) focus on either reducing knee joint loading or on increasing physical activity. There is a need for interventions that could address both quality and quantity of walking for people with knee OA. The goal of this randomized controlled trial (clinicaltrials.gov # NCT03064139) was to determine the feasibility of a mindful walking intervention to improve quality and quantity of walking in people with knee OA. Methods: Individuals with symptomatic knee OA were recruited from the community using advertisements. Study criteria are shown in Table 1. [Formula presented] During enrollment, the more symptomatic knee, or a knee selected at random in case of equal symptoms, was designated as the study knee. After the baseline visit, participants were randomized to either a mindful walking group (MWG) or an attention-matched self-management group (SMG). Participants in both groups received 11 intervention sessions delivered over a 6-month period (4 in 1 st month, 2 each in 2nd and 3rd months, 1 each in 4th, 5th, and 6th months). Interventions were delivered via in-person groups (4-10 in each group) and each session was 1.5-3 hours in duration. For MWG, a certified instructor provided training in mindful walking that includes whole-body movement retraining and mindful body-awareness skill building. Biomechanical elements include: shorter stride length, higher cadence, greater toe-in, and more aligned posture. Participants were coached to progressively increase their mindful walking activity each week. Mindfulness elements include mindful body-awareness skills to increase sensitivity and awareness of deviations from the taught techniques. The approach is based on “ChiWalking®” so called because the movement approaches are drawn in part from T’ai Chi. For SMG, a researcher delivered a curriculum consisting of education and self-management techniques (e.g., importance of physical activity and exercise, nutrition, weight-management, etc.). This information was also provided to MWG in a condensed form. Gait analyses and physical performance tests were completed at baseline and 6-months. Physical activity was assessed using a commercial wrist-worn activity monitor (Charge 3, Fitbit Inc, San Francisco, CA). Participant-reported outcomes (PROs) were completed at baseline and every 3-months. Participants were remotely followed for an additional 6-months after the end of the intervention. Given the feasibility nature of the study, primary outcomes included recruitment, adherence, retention and number of adverse events. Secondary outcomes included peak external knee adduction moment [KAM], daily step count, Knee injury and osteoarthritis outcome score (KOOS) Pain, Five Facet Mindfulness Questionnaire (FFMQ), Arthritis Self-Efficacy Scale (ASES), 30-second chair stand test (30STS), 40-meter fast paced walk test (40FPW), and Stair Climbing Test (SCT). Analyses were conducted on intention-to-treat basis with all randomized participants included and missing values were not imputed. Results: Participants were recruited between March 2019 and January 2020. During this period, ∼450 individuals completed pre-screening questionnaires (∼41 per month), 66 completed in-person screening visits, 47 were enrolled, and 44 were randomized (Table 2). Interventions for 19 participants were interrupted, delayed for 3-months, and then transitioned to virtual format due to the COVID-19 pandemic. While the original recruitment goal was 62, the trial was halted earlier due to COVID-19. [Formula presented] Attendance is shown in Table 3. On average, MWG group attended 63% of the sessions vs. 70% in the SMG group. Among those who attended at least 1 session, MWG group attended 69% vs. 77% for SMG. Among those who attended at least 3 sessions, MWG group attended 75% vs. 84% for SMG. Post-intervention, 65% (n=15) and 87% (n=20) of MWG completed the in-person visits and PROs, respectively. In SMG, 81% (n=17) completed in-person visits and PROs. At 12-months, 91% (n=21) and 71% (n 15) completed the PROs for MWG and SMG, respectively. [Formula presented] Participant feedback at 6- and 12-months showed that the intervention was acceptable (Table 4). There were no serious adverse events related to the intervention in either group. Within group and between group differences for secondary outcomes are shown in Table 5. [Formula presented] [Formula presented] Conclusions: Our benchmarks were recruitment over 1.5 years, attendance of 75% in MWG group, and retention of 80% of participants at 6-months. While all of these benchmarks were negatively impacted by COVID-19, the recruitment rates over the period studied, adherence in those who attended at least 3 sessions, and retention for some secondary outcomes were acceptable. Participants in both groups found the interventions helpful, enjoyable, and rated it highly. At 12-month follow-up, MWG participants continued to practice mindful walking 1-2 days a week. Between group differences for secondary outcomes were small. Given the feasibility nature of the study, conclusions regarding efficacy cannot be made and larger trial would be needed. Our results show that our methods are appropriate for conducting such a larger trial.

17.
PubMed; 2020.
Preprint in English | PubMed | ID: ppcovidwho-330665

ABSTRACT

Early identification of symptoms and comorbidities most predictive of COVID-19 is critical to identify infection, guide policies to effectively contain the pandemic, and improve health systems' response. Here, we characterised socio-demographics and comorbidity in 3,316,107persons tested and 219,072 persons tested positive for SARS-CoV-2 since January 2020, and their key health outcomes in the month following the first positive test. Routine care data from primary care electronic health records (EHR) from Spain, hospital EHR from the United States (US), and claims data from South Korea and the US were used. The majority of study participants were women aged 18-65 years old. Positive/tested ratio varied greatly geographically (2.2:100 to 31.2:100) and over time (from 50:100 in February-April to 6.8:100 in May-June). Fever, cough and dyspnoea were the most common symptoms at presentation. Between 4%-38% required admission and 1-10.5% died within a month from their first positive test. Observed disparity in testing practices led to variable baseline characteristics and outcomes, both nationally (US) and internationally. Our findings highlight the importance of large scale characterization of COVID-19 international cohorts to inform planning and resource allocation including testing as countries face a second wave.

18.
Open Forum Infectious Diseases ; 8(SUPPL 1):S271, 2021.
Article in English | EMBASE | ID: covidwho-1746662

ABSTRACT

Background. Nearly 4 million children have tested positive for coronavirus disease 2019 (COVID-19) in the United States. Some studies suggest infants might be at increased risk for severe illness and hospitalization from COVID-19. Our objective was to describe the clinical and laboratory features of young infants admitted to a hospital system with COVID-19. Methods. An observational retrospective study was performed in infants ≤1 year of age admitted with COVID-19 from March 1, 2020 to May 30, 2021. Data was extracted into a REDCap database and analyzed using descriptive statistics. Results. Sixteen infants < 1 year were hospitalized with COVID-19. Fever, poor feeding, and respiratory symptoms were the most common presenting symptoms (Table 1). Two required pediatric intensive care unit (ICU) care, three required oxygen support, and one was intubated. There were no deaths. Five infants with echocardiograms performed showed normal findings. Four infants received Remdesivir without side effects. Conclusion. Infants with COVID-19 can present with severe disease requiring ICU care and oxygen support. In our experience, a large proportion of infants developed hematologic abnormalities, but none had cardiac involvement. Preventive measures including vaccination will become critical to decrease transmission and severe disease in this young patient population.

19.
Open Forum Infectious Diseases ; 8(SUPPL 1):S360, 2021.
Article in English | EMBASE | ID: covidwho-1746480

ABSTRACT

Background. The aim of this pragmatic, embedded adaptive trial was to measure the effectiveness of subcutaneous sarilumab in addition to an evolving standard of care for clinical management of inpatients with moderate to severe COVID-19 disease (NCT04359901). The study is also a real-world demonstration of the realization of a prospective learning healthcare system. Methods. Two-arm, randomized, open-label controlled 5-center trial comparing standard care alone to standard care (SOC), which evolved over time, with addition of subcutaneous sarilumab (200 mg or 400 mg anti-IL6R) among hospitalized patients with moderate to severe COVID-19 not requiring mechanical ventilation. The primary outcome was 14-day incidence of intubation or death. The trial used a randomized play-the-winner design and was fully embedded within the EHR system, including the adaptive randomization process. Results. Among 417 patients screened, 162 were eligible based on chart review, 53 consented, and 50 were evaluated for the primary endpoint of intubation or death ( >30% of eligible patients enrolled) (Figure 1). After the second interim review, the unblinded Data Monitoring Committee recommended that the study be stopped due to concern for safety: a high probability that rates of intubation or death were higher with addition of sarilumab to SOC (92.6%), and a very low probability (3.4%) that sarilumab would be found to be superior. Conclusion. This randomized trial of patients hospitalized with COVID-19 and requiring supplemental oxygen but not mechanical ventilation found no evidence of benefit from subcutaneous sarilumab in addition to an evolving standard-of-care. The numbers of patients and events were too low to allow independent conclusions to be drawn, but this study contributes valuable information about the role of subcutaneous IL-6 inhibition in the treatment of patients hospitalized with COVID-19. The major innovation of this trial was the advancement of embedded, point-of-care clinical trials for FDA-approved drugs;this represents a realization of the learning healthcare system. Methods developed and piloted during the conduct of this trial can be used in future investigations to speed the advancement of clinical science.

20.
PubMed; 2021.
Preprint in English | PubMed | ID: ppcovidwho-330195

ABSTRACT

Objective: Real-world data have been critical for rapid-knowledge generation throughout the COVID-19 pandemic. To ensure high-quality results are delivered to guide clinical decision making and the public health response, as well as characterize the response to interventions, it is essential to establish the accuracy of COVID-19 case definitions derived from administrative data to identify infections and hospitalizations. Methods: Electronic Health Record (EHR) data were obtained from the clinical data warehouse of the Yale New Haven Health System (Yale, primary site) and 3 hospital systems of the Mayo Clinic (validation site). Detailed characteristics on demographics, diagnoses, and laboratory results were obtained for all patients with either a positive SARS-CoV-2 PCR or antigen test or ICD-10 diagnosis of COVID-19 (U07.1) between April 1, 2020 and March 1, 2021. Various computable phenotype definitions were evaluated for their accuracy to identify SARS-CoV-2 infection and COVID-19 hospitalizations. Results: Of the 69,423 individuals with either a diagnosis code or a laboratory diagnosis of a SARS-CoV-2 infection at Yale, 61,023 had a principal or a secondary diagnosis code for COVID-19 and 50,355 had a positive SARS-CoV-2 test. Among those with a positive laboratory test, 38,506 (76.5%) and 3449 (6.8%) had a principal and secondary diagnosis code of COVID-19, respectively, while 8400 (16.7%) had no COVID-19 diagnosis. Moreover, of the 61,023 patients with a COVID-19 diagnosis code, 19,068 (31.2%) did not have a positive laboratory test for SARS-CoV-2 in the EHR. Of the 20 cases randomly sampled from this latter group for manual review, all had a COVID-19 diagnosis code related to asymptomatic testing with negative subsequent test results. The positive predictive value (precision) and sensitivity (recall) of a COVID-19 diagnosis in the medical record for a documented positive SARS-CoV-2 test were 68.8% and 83.3%, respectively. Among 5,109 patients who were hospitalized with a principal diagnosis of COVID-19, 4843 (94.8%) had a positive SARS-CoV-2 test within the 2 weeks preceding hospital admission or during hospitalization. In addition, 789 hospitalizations had a secondary diagnosis of COVID-19, of which 446 (56.5%) had a principal diagnosis consistent with severe clinical manifestation of COVID-19 (e.g., sepsis or respiratory failure). Compared with the cohort that had a principal diagnosis of COVID-19, those with a secondary diagnosis had a more than 2-fold higher in-hospital mortality rate (13.2% vs 28.0%, P<0.001). In the validation sample at Mayo Clinic, diagnosis codes more consistently identified SARS-CoV-2 infection (precision of 95%) but had lower recall (63.5%) with substantial variation across the 3 Mayo Clinic sites. Similar to Yale, diagnosis codes consistently identified COVID-19 hospitalizations at Mayo, with hospitalizations defined by secondary diagnosis code with 2-fold higher in-hospital mortality compared to those with a primary diagnosis of COVID-19. Conclusions: COVID-19 diagnosis codes misclassified the SARS-CoV-2 infection status of many people, with implications for clinical research and epidemiological surveillance. Moreover, the codes had different performance across two academic health systems and identified groups with different risks of mortality. Real-world data from the EHR can be used to in conjunction with diagnosis codes to improve the identification of people infected with SARS-CoV-2.

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