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1.
J Asthma ; : 1-8, 2022 Jun 06.
Article in English | MEDLINE | ID: covidwho-1868129

ABSTRACT

OBJECTIVE: Hospital admission trends of children with status asthmaticus diminished during the Coronavirus-19 (COVID-19) pandemic of 2020, possibly secondary to several factors such as school closures and use of face masks. What effect this had on antibiotic prescribing practices has yet to be described. The objective of our study was to evaluate the use of antibiotics in hospitalized children with a diagnosis of status asthmaticus before and during the COVID pandemic.Methods: A retrospective cross-sectional analysis was conducted using the TriNetX® cloud-based program with a national and institutional database. Each database was queried for all inpatient pediatric encounters from 3 to 18 years old, admitted with a diagnosis of status asthmaticus in the spring seasons of 2017-2019. Admission data and antibiotic usage were queried during the COVID-19 pandemic year of 2020 from both databases and compared amongst all study years.Results: In 2020, there was an overall decrease in the number of admissions as compared to the average number from 2017-2019, by 76.9% in the national database (p < 0.05) and 91.2% in the institutional database. The rates of antibiotic prescriptions significantly dropped among the national database (p < 0.001, z = 3.39) and remained non-significantly changed among the institutional database (p = 0.944 and z = 0.073).Conclusions: Our study demonstrates that the COVID-19 pandemic year of 2020 coincided with a significant decrease in hospital admissions and antibiotic prescribing prevalence among children with status asthmaticus on a national level. Nonetheless, our reported trends in antibiotic prescribing are still grossly similar to that of pre-pandemic times and may demonstrate a continued need for antimicrobial stewardship.

2.
Clin Infect Dis ; 73(2): 336-340, 2021 07 15.
Article in English | MEDLINE | ID: covidwho-1315672

ABSTRACT

While adult clinical trials of coronavirus disease 2019 (COVID-19) vaccines have moved quickly into phase 3 clinical trials, clinical trials have not started in children in the United States. The direct COVID-19 impact upon children is greater than that observed for a number of other pathogens for which we now have effective pediatric vaccines. Additionally, the role of children in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission has clearly been underappreciated. Carefully conducted phase 2 clinical trials can adequately address potential COVID-19 vaccine safety concerns. Delaying phase 2 vaccine clinical trials in children will delay our recovery from COVID-19 and unnecessarily prolong its impact upon children's education, health, and emotional well-being, and equitable access to opportunities for development and social success. Given the potential direct and indirect benefits of pediatric vaccination, implementation of phase 2 clinical trials for COVID-19 vaccines should begin now.


Subject(s)
COVID-19 , Viral Vaccines , Adult , COVID-19 Vaccines , Child , Humans , SARS-CoV-2 , Vaccination
3.
Crit Care Med ; 49(7): 1015-1025, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1307568

ABSTRACT

OBJECTIVES: Four peer-reviewed publications have reported results from randomized controlled trials of convalescent plasma for coronavirus disease 2019 infection; none were conducted in the United States nor used standard plasma as a comparator. To determine if administration of convalescent plasma to patients with coronavirus disease 2019 increases antibodies to severe acute respiratory syndrome coronavirus 2 and improves outcome. DESIGN: Double-blind randomized controlled trial. SETTING: Hospital in New York. PATIENTS: Patients with polymerase chain reaction documented coronavirus disease 2019 infection. INTERVENTIONS: Patients were randomized (4:1) to receive 2 U of convalescent plasma versus standard plasma. Antibodies to severe acute respiratory syndrome coronavirus 2 were measured in plasma units and in trial recipients. MEASUREMENTS AND MAIN RESULTS: Enrollment was terminated after emergency use authorization was granted for convalescent plasma. Seventy-four patients were randomized. At baseline, mean (sd) Acute Physiology and Chronic Health Evaluation II score (23.4 [5.6] and 22.5 [6.6]), percent of patients intubated (19% and 20%), and median (interquartile range) days from symptom onset to randomization of 9 (6-18) and 9 (6-15), were similar in the convalescent plasma versus standard plasma arms, respectively. Convalescent plasma had high neutralizing activity (median [interquartile range] titer 1:526 [1:359-1:786]) and its administration increased antibodies to severe acute respiratory syndrome coronavirus 2 by 14.4%, whereas standard plasma administration led to an 8.6% decrease (p = 0.005). No difference was observed for ventilator-free days through 28 days (primary study endpoint): median (interquartile range) of 28 (2-28) versus 28 (0-28; p = 0.86) for the convalescent plasma and standard plasma groups, respectively. A greater than or equal to 2 point improvement in the World Health Organization scale was achieved by 20% of subjects in both arms (p = 0.99). All-cause mortality through 90 days was numerically lower in the convalescent plasma versus standard plasma groups (27% vs 33%; p = 0.63) but did not achieve statistical significance. A key prespecified subgroup analysis of time to death in patients who were intubated at baseline was statistically significant; however, sample size numbers were small. CONCLUSIONS: Administration of convalescent plasma to hospitalized patients with coronavirus disease 2019 infection increased antibodies to severe acute respiratory syndrome coronavirus disease 2 but was not associated with improved outcome.


Subject(s)
COVID-19/therapy , SARS-CoV-2 , Aged , Antibodies, Neutralizing/blood , Double-Blind Method , Female , Humans , Immunization, Passive , Immunoglobulin G/blood , Immunoglobulin M/blood , Male , Middle Aged , New York/epidemiology , Treatment Outcome
4.
Crit Care Med ; 49(7): 1015-1025, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1191494

ABSTRACT

OBJECTIVES: Four peer-reviewed publications have reported results from randomized controlled trials of convalescent plasma for coronavirus disease 2019 infection; none were conducted in the United States nor used standard plasma as a comparator. To determine if administration of convalescent plasma to patients with coronavirus disease 2019 increases antibodies to severe acute respiratory syndrome coronavirus 2 and improves outcome. DESIGN: Double-blind randomized controlled trial. SETTING: Hospital in New York. PATIENTS: Patients with polymerase chain reaction documented coronavirus disease 2019 infection. INTERVENTIONS: Patients were randomized (4:1) to receive 2 U of convalescent plasma versus standard plasma. Antibodies to severe acute respiratory syndrome coronavirus 2 were measured in plasma units and in trial recipients. MEASUREMENTS AND MAIN RESULTS: Enrollment was terminated after emergency use authorization was granted for convalescent plasma. Seventy-four patients were randomized. At baseline, mean (sd) Acute Physiology and Chronic Health Evaluation II score (23.4 [5.6] and 22.5 [6.6]), percent of patients intubated (19% and 20%), and median (interquartile range) days from symptom onset to randomization of 9 (6-18) and 9 (6-15), were similar in the convalescent plasma versus standard plasma arms, respectively. Convalescent plasma had high neutralizing activity (median [interquartile range] titer 1:526 [1:359-1:786]) and its administration increased antibodies to severe acute respiratory syndrome coronavirus 2 by 14.4%, whereas standard plasma administration led to an 8.6% decrease (p = 0.005). No difference was observed for ventilator-free days through 28 days (primary study endpoint): median (interquartile range) of 28 (2-28) versus 28 (0-28; p = 0.86) for the convalescent plasma and standard plasma groups, respectively. A greater than or equal to 2 point improvement in the World Health Organization scale was achieved by 20% of subjects in both arms (p = 0.99). All-cause mortality through 90 days was numerically lower in the convalescent plasma versus standard plasma groups (27% vs 33%; p = 0.63) but did not achieve statistical significance. A key prespecified subgroup analysis of time to death in patients who were intubated at baseline was statistically significant; however, sample size numbers were small. CONCLUSIONS: Administration of convalescent plasma to hospitalized patients with coronavirus disease 2019 infection increased antibodies to severe acute respiratory syndrome coronavirus disease 2 but was not associated with improved outcome.


Subject(s)
COVID-19/therapy , SARS-CoV-2 , Aged , Antibodies, Neutralizing/blood , Double-Blind Method , Female , Humans , Immunization, Passive , Immunoglobulin G/blood , Immunoglobulin M/blood , Male , Middle Aged , New York/epidemiology , Treatment Outcome
5.
Clin Infect Dis ; 72(6): 1067-1073, 2021 03 15.
Article in English | MEDLINE | ID: covidwho-1132453

ABSTRACT

Clinical trials of pharmacologic treatments of coronavirus disease 2019 (COVID-19) are being rapidly designed and implemented in adults. Children are often not considered during development of novel treatments for infectious diseases until very late. Although children appear to have a lower risk compared with adults of severe COVID-19 disease, a substantial number of children globally will benefit from pharmacologic treatments. It will be reasonable to extrapolate efficacy of most treatments from adult trials to children. Pediatric trials should focus on characterizing a treatment's pharmacokinetics, optimal dose, and safety across the age spectrum. These trials should use an adaptive design to efficiently add or remove arms in what will be a rapidly evolving treatment landscape, and should involve a large number of sites across the globe in a collaborative effort to facilitate efficient implementation. All stakeholders must commit to equitable access to any effective, safe treatment for children everywhere.


Subject(s)
COVID-19 , Adult , Child , Humans , Research Design , SARS-CoV-2 , Treatment Outcome
6.
J Pediatr ; 230: 23-31.e10, 2021 03.
Article in English | MEDLINE | ID: covidwho-977144

ABSTRACT

OBJECTIVE: To characterize the demographic and clinical features of pediatric severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) syndromes and identify admission variables predictive of disease severity. STUDY DESIGN: We conducted a multicenter, retrospective, and prospective study of pediatric patients hospitalized with acute SARS-CoV-2 infections and multisystem inflammatory syndrome in children (MIS-C) at 8 sites in New York, New Jersey, and Connecticut. RESULTS: We identified 281 hospitalized patients with SARS-CoV-2 infections and divided them into 3 groups based on clinical features. Overall, 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations including gastrointestinal illness or fever. Patients with MIS-C were more likely to identify as non-Hispanic black compared with patients with respiratory disease (35% vs 18%, P = .02). Seven patients (2%) died and 114 (41%) were admitted to the intensive care unit. In multivariable analyses, obesity (OR 3.39, 95% CI 1.26-9.10, P = .02) and hypoxia on admission (OR 4.01; 95% CI 1.14-14.15; P = .03) were predictive of severe respiratory disease. Lower absolute lymphocyte count (OR 8.33 per unit decrease in 109 cells/L, 95% CI 2.32-33.33, P = .001) and greater C-reactive protein (OR 1.06 per unit increase in mg/dL, 95% CI 1.01-1.12, P = .017) were predictive of severe MIS-C. Race/ethnicity or socioeconomic status were not predictive of disease severity. CONCLUSIONS: We identified variables at the time of hospitalization that may help predict the development of severe SARS-CoV-2 disease manifestations in children and youth. These variables may have implications for future prognostic tools that inform hospital admission and clinical management.


Subject(s)
COVID-19/epidemiology , Hospitalization , Severity of Illness Index , Systemic Inflammatory Response Syndrome/epidemiology , Adolescent , Biomarkers/analysis , C-Reactive Protein/analysis , COVID-19/blood , Child , Child, Preschool , Connecticut/epidemiology , Female , Humans , Hypoxia/epidemiology , Infant , Intensive Care Units , Lymphocyte Count , Male , Multivariate Analysis , New Jersey/epidemiology , New York/epidemiology , Pediatric Obesity/epidemiology , Procalcitonin/blood , Prospective Studies , Retrospective Studies , Systemic Inflammatory Response Syndrome/blood , Troponin/blood , Young Adult
7.
PLoS One ; 15(12): e0241956, 2020.
Article in English | MEDLINE | ID: covidwho-967485

ABSTRACT

OBJECTIVES: Healthcare workers face distinct occupational challenges that affect their personal health, especially during a pandemic. In this study we compare the characteristics and outcomes of Covid-19 patients who are and who are not healthcare workers (HCW). METHODS: We retrospectively analyzed a cohort of 2,842 adult patients with known HCW status and a positive SARS-CoV-2 RT-PCR test presenting to a large academic medical center emergency department (ED) in New York State from March 21 2020 through June 2020. Early in the pandemic we instituted a policy to collect data on patient occupation and exposures to suspected Covid-19. The primary outcome was hospital admission. Secondary outcomes were ICU admission, need for invasive mechanical ventilation (IMV), and mortality. We compared baseline characteristics and outcomes of Covid-19 adult patients based on whether they were or were not HCW using univariable and multivariable analyses. RESULTS: Of 2,842 adult patients (mean age 53+/-19 years, 53% male) 193 (6.8%) were HCWs and 2,649 (93.2%) were not HCWs. Compared with non-HCW, HCWs were younger (43 vs 53 years, P<0.001), more likely female (118/193 [61%] vs 1211/2649 [46%], P<0.001), and more likely to have a known Covid-19 exposure (161/193 [83%] vs 946/2649 [36%], P<0.001), but had fewer comorbidities. On presentation to the ED, HCW also had lower frequencies of tachypnea (12/193 [6%] vs 426/2649 [16%], P<0.01), hypoxemia (15/193 [8%] vs 564/2649 [21%], P<0.01), bilateral opacities on imaging (38/193 [20%] vs 1189/2649 [45%], P<0.001), and lymphocytopenia (6/193 [3%] vs 532/2649 [20%], P<0.01) compared to non-HCWs. Direct discharges home from the ED were more frequent in HCW 154/193 (80%) vs 1275/2649 (48%) p<0.001). Hospital admissions (38/193 [20%] vs 1264/2694 [47%], P<0.001), ICU admissions (7/193 [3%] vs 321/2694 [12%], P<0.001), need for IMV (6/193 [3%] vs 321/2694 [12%], P<0.001) and mortality (2/193 [1%] vs 219/2694 [8%], P<0.01) were lower than among non-HCW. After controlling for age, sex, comorbidities, presenting vital signs and radiographic imaging, HCW were less likely to be admitted (OR 0.6, 95%CI 0.3-0.9) than non HCW. CONCLUSIONS: Compared with non HCW, HCW with Covid-19 were younger, had less severe illness, and were less likely to be admitted.


Subject(s)
COVID-19 , Emergency Service, Hospital , Health Personnel , SARS-CoV-2 , Adult , Age Factors , Aged , COVID-19/diagnostic imaging , COVID-19/mortality , COVID-19/therapy , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Retrospective Studies , Sex Factors
8.
J Pediatric Infect Dis Soc ; 9(5): 596-608, 2020 Nov 10.
Article in English | MEDLINE | ID: covidwho-919282

ABSTRACT

Understanding the role that children play in the clinical burden and propagation of severe acute respiratory syndrome coronavirus 2, responsible for coronavirus disease 2019 (COVID-19) infections, is emerging. While the severe manifestations and acute clinical burden of COVID-19 have largely spared children compared with adults, understanding the epidemiology, clinical presentation, diagnostics, management, and prevention opportunities and the social and behavioral impacts on child health is vital. Foremost is clarifying the contribution of asymptomatic and mild infections to transmission within the household and community and the clinical and epidemiologic significance of uncommon severe post-infectious complications. Here, we summarize the current knowledge, identify resources, and outline research opportunities. Pediatric infectious diseases clinicians have a unique opportunity to advocate for the inclusion of children in epidemiological, clinical, treatment, and prevention studies to optimize their care as well as to represent children in the development of guidance and policy during pandemic response.


Subject(s)
Betacoronavirus , Coronavirus Infections , Pandemics , Pneumonia, Viral , Asymptomatic Diseases , COVID-19 , COVID-19 Testing , Child , Child Health Services , Clinical Laboratory Techniques , Coronavirus Infections/diagnosis , Coronavirus Infections/prevention & control , Coronavirus Infections/therapy , Coronavirus Infections/transmission , Female , Humans , Infant, Newborn , Infant, Newborn, Diseases/epidemiology , Infant, Newborn, Diseases/prevention & control , Infectious Disease Transmission, Vertical , Pandemics/prevention & control , Pediatrics , Pneumonia, Viral/diagnosis , Pneumonia, Viral/prevention & control , Pneumonia, Viral/therapy , Pneumonia, Viral/transmission , Practice Guidelines as Topic , Pregnancy , Pregnancy Complications, Infectious , SARS-CoV-2
9.
Clin Infect Dis ; 72(6): 1067-1073, 2021 03 15.
Article in English | MEDLINE | ID: covidwho-619323

ABSTRACT

Clinical trials of pharmacologic treatments of coronavirus disease 2019 (COVID-19) are being rapidly designed and implemented in adults. Children are often not considered during development of novel treatments for infectious diseases until very late. Although children appear to have a lower risk compared with adults of severe COVID-19 disease, a substantial number of children globally will benefit from pharmacologic treatments. It will be reasonable to extrapolate efficacy of most treatments from adult trials to children. Pediatric trials should focus on characterizing a treatment's pharmacokinetics, optimal dose, and safety across the age spectrum. These trials should use an adaptive design to efficiently add or remove arms in what will be a rapidly evolving treatment landscape, and should involve a large number of sites across the globe in a collaborative effort to facilitate efficient implementation. All stakeholders must commit to equitable access to any effective, safe treatment for children everywhere.


Subject(s)
COVID-19 , Adult , Child , Humans , Research Design , SARS-CoV-2 , Treatment Outcome
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