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1.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-337051

ABSTRACT

Importance: The post-acute sequelae of SARS-CoV-2 (PASC) has emerged as a long-term complication in adults, but current understanding of the clinical presentation of PASC in children is limited. Objective: To identify diagnosed symptoms, diagnosed health conditions and medications associated with PASC in children. Design, Setting and Participants: Retrospective cohort study using electronic health records from 9 US children's hospitals for individuals <21 years-old who underwent reverse transcriptase polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 between March 1, 2020 to October 31, 2021 and had at least 1 encounter in the 3 years before testing. Exposure: SARS-CoV-2 PCR positivity. Main Outcomes and Measures: We identified syndromic (symptoms), systemic (conditions), and medication PASC features in the 28-179 days following the initial test date. Adjusted hazard ratios (aHRs) were obtained for 151 clinically predicted PASC features by contrasting PCR-positive with PCR-negative groups using proportional hazards models, adjusting for site, age, sex, testing location, race/ethnicity, and time-period of cohort entrance. We estimated the incidence proportion for any syndromic, systemic or medication PASC feature in the two groups to obtain a burden of PASC estimate. Results: Among 659,286 children in the study sample, 59,893 (9.1%) tested positive by PCR for SARS-CoV-2. Most were tested in outpatient testing facility (50.3%) or office (24.6%) settings. The most common syndromic, systemic, and medication features were loss of taste or smell (aHR 1.96 [95% CI 1.16-3.32), myocarditis (aHR 3.10 [95% CI 1.94-4.96]), and cough and cold preparations (aHR 1.52 [95% CI 1.18-1.96]). The incidence of at least one systemic/syndromic/medication feature of PASC was 41.9% among PCR-positive children versus 38.2% among PCR-negative children, with an incidence proportion difference of 3.7% (95% CI 3.2-4.2%). A higher strength of association for PASC was identified in those cared for in the ICU during the acute illness phase, children less than 5 years-old, and individuals with complex chronic conditions. Conclusions and Relevance: In this large-scale, exploratory study, the burden of pediatric PASC that presented to health systems was low. Myocarditis was the most commonly diagnosed PASC-associated condition. Acute illness severity, young age, and comorbid complex chronic disease increased the risk of PASC.

2.
JAMA Netw Open ; 5(4): e227299, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1787611

ABSTRACT

Importance: Bacterial and viral causes of acute respiratory illness (ARI) are difficult to clinically distinguish, resulting in the inappropriate use of antibacterial therapy. The use of a host gene expression-based test that is able to discriminate bacterial from viral infection in less than 1 hour may improve care and antimicrobial stewardship. Objective: To validate the host response bacterial/viral (HR-B/V) test and assess its ability to accurately differentiate bacterial from viral infection among patients with ARI. Design, Setting, and Participants: This prospective multicenter diagnostic study enrolled 755 children and adults with febrile ARI of 7 or fewer days' duration from 10 US emergency departments. Participants were enrolled from October 3, 2014, to September 1, 2019, followed by additional enrollment of patients with COVID-19 from March 20 to December 3, 2020. Clinical adjudication of enrolled participants identified 616 individuals as having bacterial or viral infection. The primary analysis cohort included 334 participants with high-confidence reference adjudications (based on adjudicator concordance and the presence of an identified pathogen confirmed by microbiological testing). A secondary analysis of the entire cohort of 616 participants included cases with low-confidence reference adjudications (based on adjudicator discordance or the absence of an identified pathogen in microbiological testing). Thirty-three participants with COVID-19 were included post hoc. Interventions: The HR-B/V test quantified the expression of 45 host messenger RNAs in approximately 45 minutes to derive a probability of bacterial infection. Main Outcomes and Measures: Performance characteristics for the HR-B/V test compared with clinical adjudication were reported as either bacterial or viral infection or categorized into 4 likelihood groups (viral very likely [probability score <0.19], viral likely [probability score of 0.19-0.40], bacterial likely [probability score of 0.41-0.73], and bacterial very likely [probability score >0.73]) and compared with procalcitonin measurement. Results: Among 755 enrolled participants, the median age was 26 years (IQR, 16-52 years); 360 participants (47.7%) were female, and 395 (52.3%) were male. A total of 13 participants (1.7%) were American Indian, 13 (1.7%) were Asian, 368 (48.7%) were Black, 131 (17.4%) were Hispanic, 3 (0.4%) were Native Hawaiian or Pacific Islander, 297 (39.3%) were White, and 60 (7.9%) were of unspecified race and/or ethnicity. In the primary analysis involving 334 participants, the HR-B/V test had sensitivity of 89.8% (95% CI, 77.8%-96.2%), specificity of 82.1% (95% CI, 77.4%-86.6%), and a negative predictive value (NPV) of 97.9% (95% CI, 95.3%-99.1%) for bacterial infection. In comparison, the sensitivity of procalcitonin measurement was 28.6% (95% CI, 16.2%-40.9%; P < .001), the specificity was 87.0% (95% CI, 82.7%-90.7%; P = .006), and the NPV was 87.6% (95% CI, 85.5%-89.5%; P < .001). When stratified into likelihood groups, the HR-B/V test had an NPV of 98.9% (95% CI, 96.1%-100%) for bacterial infection in the viral very likely group and a positive predictive value of 63.4% (95% CI, 47.2%-77.9%) for bacterial infection in the bacterial very likely group. The HR-B/V test correctly identified 30 of 33 participants (90.9%) with acute COVID-19 as having a viral infection. Conclusions and Relevance: In this study, the HR-B/V test accurately discriminated bacterial from viral infection among patients with febrile ARI and was superior to procalcitonin measurement. The findings suggest that an accurate point-of-need host response test with high NPV may offer an opportunity to improve antibiotic stewardship and patient outcomes.


Subject(s)
Bacterial Infections , COVID-19 , Virus Diseases , Adult , Bacteria , Bacterial Infections/drug therapy , COVID-19/diagnosis , Child , Female , Fever/diagnosis , Gene Expression , Humans , Male , Procalcitonin , Virus Diseases/diagnosis
3.
Pediatrics ; 149(4)2022 04 01.
Article in English | MEDLINE | ID: covidwho-1760012

ABSTRACT

This national study evaluated trends in illness severity among 82 798 children with coronavirus disease 2019 from March 1, 2020, to December 30, 2021.


Subject(s)
COVID-19 , Adolescent , COVID-19/epidemiology , Child , Humans , Patient Acuity , Severity of Illness Index
5.
Clin Ther ; 44(3): 450-455, 2022 03.
Article in English | MEDLINE | ID: covidwho-1654208

ABSTRACT

Controlling the spread of severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), will rely on vaccination at increasing rates and in an equitable manner. The main reasons for under-vaccination are varied among different segments of the population and include vaccine hesitancy and lack of access. While vaccine hesitancy is complicated and requires long-term solutions, access can be enhanced through evidence-based delivery strategies that augment conventional approaches. Hospital-based COVID-19 vaccination programs hold particular promise in reaching populations with decreased vaccine access and those at higher risk for adverse outcomes from SARS-CoV-2 infection. Hospitals have the necessary equipment and storage capabilities to maintain cold chain requirements-a common challenge in the primary care setting-and can serve as a central distribution point for delivering vaccines to patients in diverse hospital locations, including inpatient units, emergency departments, urgent care centers, perioperative areas, and subspecialty clinics. They also have the capacity for mass-vaccination programs and other targeted outreach efforts. Hospital-based programs that have been successful in implementing influenza and other routine vaccinations can leverage existing infrastructure, such as electronic health record-related tools. With the possibility of COVID-19 becoming endemic, much like seasonal influenza, these programs will require flexibility as well as planning for long-term sustainability. This commentary highlights existing vaccine delivery to children in hospital-based settings, including key advantages and important challenges, and outlines how these systems could be expanded to include the COVID-19 vaccine delivery.


Subject(s)
COVID-19 , Influenza Vaccines , Influenza, Human , COVID-19/prevention & control , COVID-19 Vaccines , Child , Hospitals , Humans , Influenza, Human/epidemiology , Influenza, Human/prevention & control , SARS-CoV-2 , Vaccination
6.
Open Forum Infectious Diseases ; 8(Supplement_1):S340-S341, 2021.
Article in English | PMC | ID: covidwho-1569939
7.
Open forum infectious diseases ; 8(Suppl 1):S340-S341, 2021.
Article in English | EuropePMC | ID: covidwho-1564153

ABSTRACT

Background COVID-19 pandemic caused by SARS-CoV-2 resulted in a global health crisis in 2020. Quarantining, wearing masks and physical distancing- key infection prevention strategies implemented to stop the spread of COVID-19, also led to dramatic decreases in rates of common respiratory viral infection seen in young children. Due to lack of school and daycare exposure, we evaluated a larger than usual number of patients with periodic fevers without any known infectious contacts. Based on this observation, we conducted an analysis of all suspected cases of periodic fevers seen at our institution during the COVID-19 lockdown compared to prior seasons. Methods The clinical charts were queried for all patients presenting to any Lurie Children’s Hospital outpatient specialty clinic or laboratory with ICD diagnosis code of MO4.1 and MO4.8 (all recurrent and periodic fever syndromes) from June 1, 2020 through September 30, 2020, and compared to similar months the previous 2 years (2018 and 2019). Each patient chart was reviewed by the lead investigator to verify all new diagnoses of PFAPA. The number of new patients with PFAPA diagnosis were tallied and analyzed. Statistical comparisons were made using Kruskal-Wallis tests for monthly distributions in different years. Results We noted a significant increase in patients with new PFAPA diagnosis between June through August 2020 compared to similar months in 2018 and 2019 (Figure1). Experienced pediatric infectious disease physicians and rheumatologists diagnosed majority of the cases. During these months, a monthly median (IQR) of 13 (11.5, 14.5) patients were diagnosed among different Lurie specialty clinics, which is more than 2.5 folds increase in new PFAPA patients from the previous two years which were about 5 (3.5, 6) (Figure 2). Number of Patients with New PFAPA Diagnosis There was a significant increase in number of new patients diagnosed with PFAPA between June through August 2020 compared to similar months in 2018 and 2019. Monthly Distribution Summary for New PFAPA Diagnosis Statistical comparisons were made using Kruskal- Wallis tests for monthly distributions in different years Conclusion We observed a significant increase in PFAPA patients referred to our institution soon after introduction of public health measures to slow spread of COVID-19. Given that most children were not in daycare, schools, or camps, we suspect that parents and pediatricians were able to recognize patterns of periodic fevers in children much quicker than preceding years, when fevers would typically be attributed to an infectious process. Disclosures Ravi Jhaveri, MD, AstraZeneca (Consultant)Dynavax (Consultant)Elsevier (Other Financial or Material Support, Editorial Stipend as Co-editor in Chief, Clinical Therapeutics)Seqirus (Consultant)

8.
Clin Ther ; 43(12): 2041-2043, 2021 12.
Article in English | MEDLINE | ID: covidwho-1531132
9.
Clin Ther ; 43(10): 1646-1648, 2021 10.
Article in English | MEDLINE | ID: covidwho-1525739
10.
Clin Ther ; 43(10): 1668-1681, 2021 10.
Article in English | MEDLINE | ID: covidwho-1525738

ABSTRACT

With the marked increases in electronic health record (EHR) use for providing clinical care, there have been parallel efforts to leverage EHR data for research. EHR repositories offer the promise of vast amounts of clinical data not easily captured with traditional research methods and facilitate clinical epidemiology and comparative effectiveness research, including analyses to identify patients at higher risk for complications or who are better candidates for treatment. These types of studies have been relatively slow to penetrate the field of infectious diseases, but the need for rapid turnaround during the COVID-19 global pandemic has accelerated the uptake. This review discusses the rationale for her network projects, opportunities and challenges that such networks present, and some prior studies within the field of infectious diseases.


Subject(s)
COVID-19 , Communicable Diseases , Communicable Diseases/diagnosis , Communicable Diseases/drug therapy , Communicable Diseases/epidemiology , Comparative Effectiveness Research , Electronic Health Records , Female , Humans , SARS-CoV-2
13.
Clin Ther ; 43(9): 1435-1436, 2021 09.
Article in English | MEDLINE | ID: covidwho-1401334
15.
Clin Ther ; 43(4): 702-710, 2021 04.
Article in English | MEDLINE | ID: covidwho-1349420

ABSTRACT

The approval of the coronavirus disease 2019 (COVID-19) mRNA vaccines brought much optimism to efforts to end the pandemic. A recombinant adenovirus vaccine recently received emergency use authorization, and several other vaccines are likely to follow. These vaccines all use relatively new vaccine production platforms to produce the severe acute respiratory syndrome coronavirus 2 Spike protein. This review discusses how these platforms work, what advantages they offer, and the gaps that remain in public health efforts to control the COVID-19 pandemic. (Clin Ther. 2021;43:702-710) © 2021 Elsevier HS Journals, Inc.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Spike Glycoprotein, Coronavirus/immunology , Humans , SARS-CoV-2/immunology
16.
Clin Ther ; 43(6): e163-e172, 2021 06.
Article in English | MEDLINE | ID: covidwho-1240250

ABSTRACT

Young children will ultimately need to be vaccinated to stop the spread of coronavirus disease 2019 (COVID-19). Initial studies of vaccine were performed in adults. Randomized controlled trials are the gold standard. In the COVID-19 pandemic, many questions need to be answered about the ethics and feasibility of these trials. Given the harms of the COVID-19 pandemic and the now-known efficacy of the vaccines in adults and teens, the question of whether clinical equipoise exists for a placebo-controlled trial of vaccines in younger children remains. Parents may be reluctant to enroll children in these trials because they want their child to receive the vaccine or because they are worried about vaccines or clinical trials in general. One option for gathering data on tolerability and efficacy in children would be to use a nonrandomized trial to enroll parents willing to vaccinate their children and those who are hesitant. We discuss the advantages and disadvantages of such an open-label trial that could provide guidance for future pandemics. (Clin Ther.


Subject(s)
COVID-19 Vaccines , COVID-19 , Clinical Trials as Topic , Pandemics , COVID-19/epidemiology , COVID-19/prevention & control , Child , Child, Preschool , Clinical Trials as Topic/ethics , Ethical Analysis , Humans , Pandemics/prevention & control , SARS-CoV-2
17.
Clin Ther ; 43(4): 702-710, 2021 04.
Article in English | MEDLINE | ID: covidwho-1174153

ABSTRACT

The approval of the coronavirus disease 2019 (COVID-19) mRNA vaccines brought much optimism to efforts to end the pandemic. A recombinant adenovirus vaccine recently received emergency use authorization, and several other vaccines are likely to follow. These vaccines all use relatively new vaccine production platforms to produce the severe acute respiratory syndrome coronavirus 2 Spike protein. This review discusses how these platforms work, what advantages they offer, and the gaps that remain in public health efforts to control the COVID-19 pandemic. (Clin Ther. 2021;43:702-710) © 2021 Elsevier HS Journals, Inc.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Spike Glycoprotein, Coronavirus/immunology , Humans , SARS-CoV-2/immunology
19.
Clin Ther ; 43(3): 549-556, 2021 03.
Article in English | MEDLINE | ID: covidwho-1049763

ABSTRACT

In December 2020, the US Food and Drug Administration issued emergency use authorizations for two mRNA vaccines against coronavirus disease 2019. These vaccines represent an incredible scientific achievement and a major step in efforts to bring the global pandemic to a close. However, these vaccines create many logistical challenges that limit just how far-reaching their impact can be. This commentary reviews how these vaccines offer immunity, summarizes the Phase III trial results, and offers a discussion of the challenges that remain after these vaccines are introduced for widespread use.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Humans , Pandemics/prevention & control , SARS-CoV-2/immunology
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