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14 results on '"Katherine Irby"'

1. Maternal Vaccination and Risk of Hospitalization for Covid-19 among Infants

Author

Natasha B, Halasa, Samantha M, Olson, Mary A, Staat, Margaret M, Newhams, Ashley M, Price, Pia S, Pannaraj, Julie A, Boom, Leila C, Sahni, Kathleen, Chiotos, Melissa A, Cameron, Katherine E, Bline, Charlotte V, Hobbs, Aline B, Maddux, Bria M, Coates, Kelly N, Michelson, Sabrina M, Heidemann, Katherine, Irby, Ryan A, Nofziger, Elizabeth H, Mack, Laura, Smallcomb, Stephanie P, Schwartz, Tracie C, Walker, Shira J, Gertz, Jennifer E, Schuster, Satoshi, Kamidani, Keiko M, Tarquinio, Samina S, Bhumbra, Mia, Maamari, Janet R, Hume, Hillary, Crandall, Emily R, Levy, Matt S, Zinter, Tamara T, Bradford, Heidi R, Flori, Melissa L, Cullimore, Michele, Kong, Natalie Z, Cvijanovich, Suzanne M, Gilboa, Kara N, Polen, Angela P, Campbell, Adrienne G, Randolph, and Manish M, Patel

Subjects
Vaccines, Synthetic, COVID-19 Vaccines, SARS-CoV-2, Vaccination, COVID-19, Infant, Mothers, Obstetrics and Gynecology, General Medicine, Hospitalization, Pregnancy, Humans, Female, mRNA Vaccines, Pregnancy Complications, Infectious
Abstract

Infants younger than 6 months of age are at high risk for complications of coronavirus disease 2019 (Covid-19) and are not eligible for vaccination. Transplacental transfer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) after maternal Covid-19 vaccination may confer protection against Covid-19 in infants.We used a case-control test-negative design to assess the effectiveness of maternal vaccination during pregnancy against hospitalization for Covid-19 among infants younger than 6 months of age. Between July 1, 2021, and March 8, 2022, we enrolled infants hospitalized for Covid-19 (case infants) and infants hospitalized without Covid-19 (control infants) at 30 hospitals in 22 states. We estimated vaccine effectiveness by comparing the odds of full maternal vaccination (two doses of mRNA vaccine) among case infants and control infants during circulation of the B.1.617.2 (delta) variant (July 1, 2021, to December 18, 2021) and the B.1.1.259 (omicron) variant (December 19, 2021, to March 8, 2022).A total of 537 case infants (181 of whom had been admitted to a hospital during the delta period and 356 during the omicron period; median age, 2 months) and 512 control infants were enrolled and included in the analyses; 16% of the case infants and 29% of the control infants had been born to mothers who had been fully vaccinated against Covid-19 during pregnancy. Among the case infants, 113 (21%) received intensive care (64 [12%] received mechanical ventilation or vasoactive infusions). Two case infants died from Covid-19; neither infant's mother had been vaccinated during pregnancy. The effectiveness of maternal vaccination against hospitalization for Covid-19 among infants was 52% (95% confidence interval [CI], 33 to 65) overall, 80% (95% CI, 60 to 90) during the delta period, and 38% (95% CI, 8 to 58) during the omicron period. Effectiveness was 69% (95% CI, 50 to 80) when maternal vaccination occurred after 20 weeks of pregnancy and 38% (95% CI, 3 to 60) during the first 20 weeks of pregnancy.Maternal vaccination with two doses of mRNA vaccine was associated with a reduced risk of hospitalization for Covid-19, including for critical illness, among infants younger than 6 months of age. (Funded by the Centers for Disease Control and Prevention.).

Published
2022

2. BNT162b2 Protection against the Omicron Variant in Children and Adolescents

Author

Ashley M, Price, Samantha M, Olson, Margaret M, Newhams, Natasha B, Halasa, Julie A, Boom, Leila C, Sahni, Pia S, Pannaraj, Katherine, Irby, Katherine E, Bline, Aline B, Maddux, Ryan A, Nofziger, Melissa A, Cameron, Tracie C, Walker, Stephanie P, Schwartz, Elizabeth H, Mack, Laura, Smallcomb, Jennifer E, Schuster, Charlotte V, Hobbs, Satoshi, Kamidani, Keiko M, Tarquinio, Tamara T, Bradford, Emily R, Levy, Kathleen, Chiotos, Samina S, Bhumbra, Natalie Z, Cvijanovich, Sabrina M, Heidemann, Melissa L, Cullimore, Shira J, Gertz, Bria M, Coates, Mary A, Staat, Matt S, Zinter, Michele, Kong, Brandon M, Chatani, Janet R, Hume, Katri V, Typpo, Mia, Maamari, Heidi R, Flori, Mark W, Tenforde, Laura D, Zambrano, Angela P, Campbell, Manish M, Patel, and Adrienne G, Randolph

Subjects
Vaccines, Synthetic, COVID-19 Vaccines, Adolescent, SARS-CoV-2, Critical Illness, COVID-19, Vaccine Efficacy, General Medicine, Hospitalization, Case-Control Studies, Child, Preschool, Humans, mRNA Vaccines, Child, BNT162 Vaccine
Abstract

Spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.1.529 (omicron) variant, which led to increased U.S. hospitalizations for coronavirus disease 2019 (Covid-19), generated concern about immune evasion and the duration of protection from vaccines in children and adolescents.Using a case-control, test-negative design, we assessed vaccine effectiveness against laboratory-confirmed Covid-19 leading to hospitalization and against critical Covid-19 (i.e., leading to receipt of life support or to death). From July 1, 2021, to February 17, 2022, we enrolled case patients with Covid-19 and controls without Covid-19 at 31 hospitals in 23 states. We estimated vaccine effectiveness by comparing the odds of antecedent full vaccination (two doses of BNT162b2 messenger RNA vaccine) at least 14 days before illness among case patients and controls, according to time since vaccination for patients 12 to 18 years of age and in periods coinciding with circulation of B.1.617.2 (delta) (July 1, 2021, to December 18, 2021) and omicron (December 19, 2021, to February 17, 2022) among patients 5 to 11 and 12 to 18 years of age.We enrolled 1185 case patients (1043 [88%] of whom were unvaccinated, 291 [25%] of whom received life support, and 14 of whom died) and 1627 controls. During the delta-predominant period, vaccine effectiveness against hospitalization for Covid-19 among adolescents 12 to 18 years of age was 93% (95% confidence interval [CI], 89 to 95) 2 to 22 weeks after vaccination and was 92% (95% CI, 80 to 97) at 23 to 44 weeks. Among adolescents 12 to 18 years of age (median interval since vaccination, 162 days) during the omicron-predominant period, vaccine effectiveness was 40% (95% CI, 9 to 60) against hospitalization for Covid-19, 79% (95% CI, 51 to 91) against critical Covid-19, and 20% (95% CI, -25 to 49) against noncritical Covid-19. During the omicron period, vaccine effectiveness against hospitalization among children 5 to 11 years of age was 68% (95% CI, 42 to 82; median interval since vaccination, 34 days).BNT162b2 vaccination reduced the risk of omicron-associated hospitalization by two thirds among children 5 to 11 years of age. Although two doses provided lower protection against omicron-associated hospitalization than against delta-associated hospitalization among adolescents 12 to 18 years of age, vaccination prevented critical illness caused by either variant. (Funded by the Centers for Disease Control and Prevention.).

Published
2022

3. Effectiveness of BNT162b2 Vaccine against Critical Covid-19 in Adolescents

Author

Samantha M, Olson, Margaret M, Newhams, Natasha B, Halasa, Ashley M, Price, Julie A, Boom, Leila C, Sahni, Pia S, Pannaraj, Katherine, Irby, Tracie C, Walker, Stephanie P, Schwartz, Aline B, Maddux, Elizabeth H, Mack, Tamara T, Bradford, Jennifer E, Schuster, Ryan A, Nofziger, Melissa A, Cameron, Kathleen, Chiotos, Melissa L, Cullimore, Shira J, Gertz, Emily R, Levy, Michele, Kong, Natalie Z, Cvijanovich, Mary A, Staat, Satoshi, Kamidani, Brandon M, Chatani, Samina S, Bhumbra, Katherine E, Bline, Mary G, Gaspers, Charlotte V, Hobbs, Sabrina M, Heidemann, Mia, Maamari, Heidi R, Flori, Janet R, Hume, Matt S, Zinter, Kelly N, Michelson, Laura D, Zambrano, Angela P, Campbell, Manish M, Patel, and Adrienne G, Randolph

Subjects
Male, COVID-19 Vaccines, Adolescent, SARS-CoV-2, Immunization, Secondary, Patient Acuity, COVID-19, Vaccine Efficacy, General Medicine, United States, Hospitalization, Life Support Care, Intensive Care Units, COVID-19 Testing, Editorial, Case-Control Studies, Humans, Female, Child, BNT162 Vaccine
Abstract

The increasing incidence of pediatric hospitalizations associated with coronavirus disease 2019 (Covid-19) caused by the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the United States has offered an opportunity to assess the real-world effectiveness of the BNT162b2 messenger RNA vaccine in adolescents between 12 and 18 years of age.We used a case-control, test-negative design to assess vaccine effectiveness against Covid-19 resulting in hospitalization, admission to an intensive care unit (ICU), the use of life-supporting interventions (mechanical ventilation, vasopressors, and extracorporeal membrane oxygenation), or death. Between July 1 and October 25, 2021, we screened admission logs for eligible case patients with laboratory-confirmed Covid-19 at 31 hospitals in 23 states. We estimated vaccine effectiveness by comparing the odds of antecedent full vaccination (two doses of BNT162b2) in case patients as compared with two hospital-based control groups: patients who had Covid-19-like symptoms but negative results on testing for SARS-CoV-2 (test-negative) and patients who did not have Covid-19-like symptoms (syndrome-negative).A total of 445 case patients and 777 controls were enrolled. Overall, 17 case patients (4%) and 282 controls (36%) had been fully vaccinated. Of the case patients, 180 (40%) were admitted to the ICU, and 127 (29%) required life support; only 2 patients in the ICU had been fully vaccinated. The overall effectiveness of the BNT162b2 vaccine against hospitalization for Covid-19 was 94% (95% confidence interval [CI], 90 to 96); the effectiveness was 95% (95% CI, 91 to 97) among test-negative controls and 94% (95% CI, 89 to 96) among syndrome-negative controls. The effectiveness was 98% against ICU admission and 98% against Covid-19 resulting in the receipt of life support. All 7 deaths occurred in patients who were unvaccinated.Among hospitalized adolescent patients, two doses of the BNT162b2 vaccine were highly effective against Covid-19-related hospitalization and ICU admission or the receipt of life support. (Funded by the Centers for Disease Control and Prevention.).

Published
2022

4. Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19–Associated Hospitalization in Infants Aged <6 Months — 17 States, July 2021–January 2022

Author

Natasha B, Halasa, Samantha M, Olson, Mary A, Staat, Margaret M, Newhams, Ashley M, Price, Julie A, Boom, Leila C, Sahni, Melissa A, Cameron, Pia S, Pannaraj, Katherine E, Bline, Samina S, Bhumbra, Tamara T, Bradford, Kathleen, Chiotos, Bria M, Coates, Melissa L, Cullimore, Natalie Z, Cvijanovich, Heidi R, Flori, Shira J, Gertz, Sabrina M, Heidemann, Charlotte V, Hobbs, Janet R, Hume, Katherine, Irby, Satoshi, Kamidani, Michele, Kong, Emily R, Levy, Elizabeth H, Mack, Aline B, Maddux, Kelly N, Michelson, Ryan A, Nofziger, Jennifer E, Schuster, Stephanie P, Schwartz, Laura, Smallcomb, Keiko M, Tarquinio, Tracie C, Walker, Matt S, Zinter, Suzanne M, Gilboa, Kara N, Polen, Angela P, Campbell, Adrienne G, Randolph, Manish M, Patel, and Mia, Maamari

Subjects
Vaccines, Synthetic, COVID-19 Vaccines, Health (social science), SARS-CoV-2, Epidemiology, Health, Toxicology and Mutagenesis, Immunization, Passive, Infant, Newborn, COVID-19, Infant, General Medicine, Hospitals, Pediatric, United States, Hospitalization, Health Information Management, Pregnancy, Case-Control Studies, Humans, Female, mRNA Vaccines, Immunity, Maternally-Acquired
Abstract

COVID-19 vaccination is recommended for persons who are pregnant, breastfeeding, trying to get pregnant now, or who might become pregnant in the future, to protect them from COVID-19.

Published
2022

5. Hypokalemia Measurement and Management in Patients With Status Asthmaticus on Continuous Albuterol

Author

Courtney Cox, Krishna Patel, Rebecca Cantu, Chary Akmyradov, and Katherine Irby

Subjects
Status Asthmaticus, Pediatrics, Perinatology and Child Health, Humans, Albuterol, Hypokalemia, General Medicine, Child, Pediatrics, Bronchodilator Agents, Retrospective Studies
Abstract

OBJECTIVE Status asthmaticus is commonly treated in pediatric patients by using continuous albuterol, which can cause hypokalemia. The primary aim of this study was to determine if serial potassium monitoring is necessary by examining treatment frequency of hypokalemia. METHODS This retrospective analysis was performed in 185 pediatric patients admitted with status asthmaticus requiring continuous albuterol between 2017 and 2019. All patients were placed on intravenous fluids containing potassium. The primary outcome measure was the treatment of hypokalemia in relation to the number of laboratory draws for potassium levels. The secondary outcome measure was hypokalemia frequency and relation to the duration and initial dose of continuous albuterol. RESULTS Included were 156 patients with 420 laboratory draws (average, 2.7 per patient) for potassium levels. The median lowest potassium level was 3.40 mmol/L (interquartile range, 3.2–3.7). No correlation was found between initial albuterol dose and lowest potassium level (P = .52). Patients with hypokalemia had a mean albuterol time of 12.32 (SD, 15.76) hours, whereas patients without hypokalemia had a mean albuterol time of 11.50 (SD, 12.53) hours (P = .29). Potassium levels were treated 13 separate times. CONCLUSIONS The number of laboratory draws for potassium levels was high in our cohort, with few patients receiving treatment for hypokalemia beyond the potassium routinely added to maintenance fluids. Length of time on albuterol and dose of albuterol were not shown to increase the risk of hypokalemia. Serial laboratory measurements may be decreased to potentially reduce health care costs, pain, and anxiety surrounding needlesticks.

Published
2022

6. The Notch1/CD22 signaling axis disrupts Treg cell function in SARS-CoV2-associated multisystem inflammatory syndrome in children

Author

Mehdi Benamar, Qian Chen, Janet Chou, Amélie M. Julé, Rafik Boudra, Paola Contini, Elena Crestani, Peggy S. Lai, Muyun Wang, Jason Fong, Shira Rockwitz, Pui Lee, Tsz Man Fion Chan, Ekin Zeynep Altun, Eda Kepenekli, Elif Karakoc-Aydiner, Ahmet Ozen, Perran Boran, Fatih Aygun, Pinar Onal, Ayse Ayzit Kilinc Sakalli, Haluk Cokugras, Metin Yusuf Gelmez, Fatma Betul Oktelik, Esin Aktas Cetin, Yuelin Zhong, Maria Lucia Taylor, Katherine Irby, Natasha B. Halasa, Elizabeth H. Mack, Sara Signa, Ignazia Prigione, Marco Gattorno, Nicola Cotugno, Donato Amodio, Raif S. Geha, Mary Beth Son, Jane Newburger, Pankaj B. Agrawal, Stefano Volpi, Paolo Palma, Ayca Kiykim, Adrienne G. Randolph, Gunnur Deniz, Safa Baris, Raffaele De Palma, Klaus Schmitz-Abe, Louis-Marie Charbonnier, Lauren A. Henderson, Talal A. Chatila, and Benamar M., Chen Q., Chou J., Julé A. M. , Boudra R., Contini P., Crestani E., Lai P. S. , Wang M., Fong J., et al.

Subjects
Adaptive immunity, Immunology, T cells, COVID-19, General Medicine, Tolerance, Settore MED/38
Abstract

Multisystem inflammatory syndrome in children (MIS-C) evolves in some pediatric patients following acute infection with SARS-CoV-2 by hitherto unknown mechanisms. Whereas acute-COVID-19 severity and outcomes were previously correlated with Notch4 expression on Tregs, here, we show that Tregs in MIS-C were destabilized through a Notch1-dependent mechanism. Genetic analysis revealed that patients with MIS-C had enrichment of rare deleterious variants affecting inflammation and autoimmunity pathways, including dominant-negative mutations in the Notch1 regulators NUMB and NUMBL leading to Notch1 upregulation. Notch1 signaling in Tregs induced CD22, leading to their destabilization in a mTORC1-dependent manner and to the promotion of systemic inflammation. These results identify a Notch1/CD22 signaling axis that disrupts Treg function in MIS-C and point to distinct immune checkpoints controlled by individual Treg Notch receptors that shape the inflammatory outcome in SARS-CoV-2 infection.

Published
2022

7. Factors associated with COVID-19 non-vaccination in adolescents hospitalized without COVID-19

Author

Leila C Sahni, Ashley M Price, Samantha M Olson, Margaret M Newhams, Pia S Pannaraj, Aline B Maddux, Natasha B Halasa, Katherine E Bline, Melissa A Cameron, Stephanie P Schwartz, Tracie C Walker, Katherine Irby, Kathleen Chiotos, Ryan A Nofziger, Elizabeth H Mack, Laura Smallcomb, Tamara T Bradford, Satoshi Kamidani, Keiko M Tarquinio, Natalie Z Cvijanovich, Jennifer E Schuster, Samina S Bhumbra, Emily R Levy, Charlotte V Hobbs, Melissa L Cullimore, Bria M Coates, Sabrina M Heidemann, Shira J Gertz, Michele Kong, Heidi R Flori, Mary A Staat, Matt S Zinter, Janet R Hume, Brandon M Chatani, Mary G Gaspers, Mia Maamari, Adrienne G Randolph, Manish M Patel, and Julie A Boom

Subjects
Infectious Diseases, Pediatrics, Perinatology and Child Health, General Medicine
Abstract

Background Pfizer-BioNTech COVID-19 vaccine received emergency use authorization for persons ≥ 16 years in December 2020 and for adolescents 12–15 years in May 2021. Despite the clear benefits and favorable safety profile, vaccine uptake in adolescents has been suboptimal. We sought to assess factors associated with COVID-19 non-vaccination in adolescents 12–18 years of age. Methods Between June 1, 2021 and April 29, 2022, we assessed factors associated with COVID-19 non-vaccination in hospitalized adolescents ages 12–18 years enrolled in the Overcoming COVID-19 vaccine effectiveness network. Demographic characteristics and clinical information were captured through parent interviews and/or electronic medical record abstraction; COVID-19 vaccination was assessed through documented sources. We assessed associations between receipt of the COVID-19 vaccine and demographic and clinical factors using univariate and multivariable logistic regression and estimated adjusted odds ratios (aOR) for each factor associated with non-vaccination. Results Among 1665 hospitalized adolescents without COVID-19, 56% were unvaccinated. Unvaccinated adolescents were younger (median age 15.1 years vs. 15.4 years, p Conclusions Efforts to increase COVID-19 vaccination of adolescents should focus on persons with geographic, socioeconomic, and medical risk factors associated with non-vaccination.

Published
2022

8. Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12-18 Years - United States, July-December 2021

Author

Laura D, Zambrano, Margaret M, Newhams, Samantha M, Olson, Natasha B, Halasa, Ashley M, Price, Julie A, Boom, Leila C, Sahni, Satoshi, Kamidani, Keiko M, Tarquinio, Aline B, Maddux, Sabrina M, Heidemann, Samina S, Bhumbra, Katherine E, Bline, Ryan A, Nofziger, Charlotte V, Hobbs, Tamara T, Bradford, Natalie Z, Cvijanovich, Katherine, Irby, Elizabeth H, Mack, Melissa L, Cullimore, Pia S, Pannaraj, Michele, Kong, Tracie C, Walker, Shira J, Gertz, Kelly N, Michelson, Melissa A, Cameron, Kathleen, Chiotos, Mia, Maamari, Jennifer E, Schuster, Amber O, Orzel, Manish M, Patel, Angela P, Campbell, Adrienne G, Randolph, and Cindy, Bowens

Subjects
Male, Health (social science), Adolescent, Epidemiology, SARS-CoV-2, Health, Toxicology and Mutagenesis, Patient Acuity, COVID-19, Vaccine Efficacy, General Medicine, Systemic Inflammatory Response Syndrome, United States, COVID-19 Drug Treatment, Hospitalization, Health Information Management, Case-Control Studies, Humans, Female, Full Report, Child, BNT162 Vaccine
Abstract

Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after a typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In the United States, the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine is currently authorized for use in children and adolescents aged 5-15 years under an Emergency Use Authorization and is fully licensed by the Food and Drug Administration for persons aged ≥16 years (4). Prelicensure randomized trials in persons aged ≥5 years documented high vaccine efficacy and immunogenicity (5)

Published
2022

9. Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience

Author

Angelique E. Boutzoukas, Rachel Olson, Mary Ann Sellers, Gwenyth Fischer, Chi D. Hornik, Omar Alibrahim, Kelechi Iheagwara, Kamal Abulebda, Andora L. Bass, Katherine Irby, Anjali Subbaswamy, Elizabeth E. Zivick, Jill Sweney, Anne G. Stormorken, Erin E. Barker, Riad Lutfi, Michael C. McCrory, John M. Costello, Kate G. Ackerman, Jennifer C. Munoz Pareja, J. Michael Dean, Nael Abdelsamad, Daniel F. Hanley, W. Andrew Mould, Karen Lane, Mary Stroud, Bryan J. Feger, Rachel G. Greenberg, P. Brian Smith, Daniel K. Benjamin, Christoph P. Hornik, Kanecia O. Zimmerman, and Mara L. Becker

Subjects
Pharmacology (medical), General Medicine
Abstract

Timely trial start-up is a key determinant of trial success; however, delays during start-up are common and costly. Moreover, data on start-up metrics in pediatric clinical trials are sparse. To expedite trial start-up, the Trial Innovation Network piloted three novel mechanisms in the trial titled Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE), a multi-site, randomized, double-blind, placebo-controlled trial in the pediatric intensive care setting.The three novel start-up mechanisms included: 1) competitive activation; 2) use of trial start-up experts, called site navigators; and 3) supplemental funds earned for achieving pre-determined milestones. After sites were activated, they received a web-based survey to report perceptions of the DOSE start-up process. In addition to perceptions, metrics analyzed included milestones met, time to start-up, and subsequent enrollment of subjects.Twenty sites were selected for participation, with 19 sites being fully activated. Across activated sites, the median (quartile 1, quartile 3) time from receipt of regulatory documents to site activation was 82 days (68, 113). Sites reported that of the three novel mechanisms, the most motivating factor for expeditious activation was additional funding available for achieving start-up milestones, followed by site navigator assistance and then competitive site activation.Study start-up is a critical time for the success of clinical trials, and innovative methods to minimize delays during start-up are needed. Milestone-based funds and site navigators were preferred mechanisms by sites participating in the DOSE study and may have contributed to the expeditious start-up timeline achieved.gov #: NCT03938857.

Published
2023

10. Effectiveness of Pfizer-BioNTech mRNA Vaccination Against COVID-19 Hospitalization Among Persons Aged 12-18 Years - United States, June-September 2021

Author

Samantha M, Olson, Margaret M, Newhams, Natasha B, Halasa, Ashley M, Price, Julie A, Boom, Leila C, Sahni, Katherine, Irby, Tracie C, Walker, Stephanie P, Schwartz, Pia S, Pannaraj, Aline B, Maddux, Tamara T, Bradford, Ryan A, Nofziger, Benjamin J, Boutselis, Melissa L, Cullimore, Elizabeth H, Mack, Jennifer E, Schuster, Shira J, Gertz, Natalie Z, Cvijanovich, Michele, Kong, Melissa A, Cameron, Mary A, Staat, Emily R, Levy, Brandon M, Chatani, Kathleen, Chiotos, Laura D, Zambrano, Angela P, Campbell, Manish M, Patel, Adrienne G, Randolph, and Jennifer N, Oates

Subjects
Male, Pediatrics, medicine.medical_specialty, 2019-20 coronavirus outbreak, Health (social science), COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), Adolescent, Epidemiology, Hospitalized patients, Health, Toxicology and Mutagenesis, Food and drug administration, Health Information Management, Pandemic, Medicine, Humans, Child, Vaccines, Synthetic, business.industry, COVID-19, General Medicine, medicine.disease, Obesity, Confidence interval, United States, Vaccination, Hospitalization, Female, business
Abstract

Pfizer-BioNTech COVID-19 vaccine is authorized for use in children and adolescents aged 12-15 years and is licensed by the Food and Drug Administration (FDA) for persons aged ≥16 (1). A randomized placebo-controlled trial demonstrated an efficacy of 100% (95% confidence interval [CI] = 75.3%-100%) in preventing outpatient COVID-19 in persons aged 12-15 years (2); however, data among adolescents on vaccine effectiveness (VE) against COVID-19 in real-world settings are limited, especially among hospitalized patients. In early September 2021, U.S. pediatric COVID-19 hospitalizations reached the highest level during the pandemic (3,4). In a test-negative, case-control study at 19 pediatric hospitals in 16 states during June 1-September 30, 2021, the effectiveness of 2 doses of Pfizer-BioNTech vaccine against COVID-19 hospitalization was assessed among children and adolescents aged 12-18 years. Among 464 hospitalized persons aged 12-18 years (179 case-patients and 285 controls), the median age was 15 years, 72% had at least one underlying condition, including obesity, and 68% attended in-person school. Effectiveness of 2 doses of Pfizer-BioNTech vaccine against COVID-19 hospitalization was 93% (95% CI = 83%-97%), during the period when B.1.617.2 (Delta) was the predominant variant. This evaluation demonstrated that 2 doses of Pfizer-BioNTech vaccine are highly effective at preventing COVID-19 hospitalization among persons aged 12-18 years and reinforces the importance of vaccination to protect U.S. youths against severe COVID-19.

Published
2021

11. Data-driven clustering identifies features distinguishing multisystem inflammatory syndrome from acute COVID-19 in children and adolescents

Author

Shira J. Gertz, Vijaya L. Soma, Margaret M. Newhams, Courtney M. Rowan, Aline B Maddux, Aalok R. Singh, Tamara T. Bradford, Mark W. Hall, Mary Beth F. Son, Manish M. Patel, Michele Kong, Natalie Z. Cvijanovich, John K. McGuire, Gwenn E. McLaughlin, Laura Loftis, Overcoming Covid Investigators, Philip C. Spinella, Julie C. Fitzgerald, Steven M. Horwitz, Elizabeth H. Mack, Alon Geva, Katharine N. Clouser, Heda Dapul, Cindy Bowens, Sule Doymaz, Becky J. Riggs, Stephanie P Schwartz, Jennifer E. Schuster, Leora R. Feldstein, Keiko M. Tarquinio, Sabrina M. Heidemann, Cameron C. Young, Katherine Irby, Christopher L. Carroll, Jane W. Newburger, Mary Allen Staat, Kenneth D. Mandl, John S. Giuliano, Mark W Tenforde, Peter M. Mourani, Christopher J. Babbitt, Charlotte V. Hobbs, Janet R. Hume, Mia Maamari, Kevin M Havlin, Adrienne G. Randolph, and Natasha B. Halasa

Subjects
medicine.medical_specialty, Medicine (General), medicine.diagnostic_test, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Mucocutaneous zone, Pulmonary disease, COVID-19, Multisystem inflammatory syndrome, General Medicine, medicine.disease, Pediatrics, Article, Clustering, Pneumonia, R5-920, Internal medicine, Medicine, High likelihood, Critical care medicine, business, Chest radiograph, Cluster analysis
Abstract

Background: Multisystem inflammatory syndrome in children (MIS-C) consensus criteria were designed for maximal sensitivity and therefore capture patients with acute COVID-19 pneumonia. Methods: We performed unsupervised clustering on data from 1,526 patients (684 labeled MIS-C by clinicians)

Published
2021

12. Risk Factors for Critical Coronavirus Disease 2019 and Mortality in Hospitalized Young Adults: An Analysis of the Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study (VIRUS) Coronavirus Disease 2019 Registry

Author

Sandeep Tripathi, MD, MS, Imran A. Sayed, MD, Heda Dapul, MD, Jeremy S. McGarvey, MS, Jennifer A. Bandy, RN, Karen Boman, BS, Vishakha K. Kumar, MD, MBA, Vikas Bansal, MBBS, MPH, Lynn Retford, CAE, Sreekanth Cheruku, MD, MPH, Margit Kaufman, MD, FASA, Smith F. Heavner, MS, RN, Valerie C. Danesh, PhD, RN, Catherine A. St. Hill, DVM, PhD, Ashish K. Khanna, MD, Utpal Bhalala, MD, Rahul Kashyap, MBBS, MBA, Ognjen Gajic, MD, MS, Allan J. Walkey, MD, MS, Katja M. Gist, DO, MSc, for The Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study (VIRUS): COVID-19 Registry Investigator Group, Jean-Baptiste Mesland, Pierre Henin, Hélène Petre, Isabelle Buelens, Anne-Catherine Gerard, Philippe Clevenbergh, Rolando Claure-Del Granado, Jose A. Mercado, Esdenka Vega-Terrazas, Maria F. Iturricha-Caceres, Ruben Garza, Eric Chu, Victoria Chan, Oscar Y Gavidia, Felipe Pachon, Yeimy A Sanchez, Mohamed El Kassas, Mohamed Badr, Ahmed Tawheed, Hend Yahia, Sierra-Hoffman, Fernando Valerio, Oscar Diaz, Jose Luis Ramos Coello, Guillermo Perez, Ana Karen Vallecillo Lizardo, Gabina María Reyes Guillen, Helin Archaga Soto, Mradul Kumar Daga, Munisha Agarwal, Ishan Rohtagi, Anusha Cherian, Sreejith Parameswaran, Magesh Parthiban, Menu Priya A., Girish Vadgaonkar, Rekha Ediga, Shilpa Basety, Shwetha Dammareddy, Phani Sreeharsha Kasumalla, Sridhar Papani, Mahesh Kamuram, Smitha S. Segu, Tuhin Chakraborty, Epcebha Joyce, Umamaheswara Raju, Janaki Manduva, Naresh Kolakani, Shreeja Sripathi, Sheetal Chaitanya, Surapaneni Krishna Mohan, Ekambaram Jyothisree, Kamlesh Kumar Agrawal, Vijendra Baghel, Kirti Kumar Patel, Nooshin Dalili, Mohsen Nafa, Sandeep Tripathi, Yuki Itagaki, Akira Kodate, Reina Suzuki, Yuki Takahashi, Koyo Moriki, Michihito Kyo, Masamitsu Sanui, Sho Horikita, Wataru Matsuda, Shu Tahara, Mineji Hayakawa, Kunihiko Maekawa, Takuya Shiga, Yudai Iwasaki, Abdulrahman AlFares, Rene Rodriguez-Gutierrez, Jose Gerardo Gonzalez-Gonzalez, Alejandro Salcido-Montenegro, Adrian Camacho-Ortiz, Fatimah Hassan-Hanga, Hadiza Galadanci, Abubakar Shehu Gezawa, Halima M. S. Kabara, Taiwo Gboluwaga Amole, Halima Kabir, Dalha Gwarzo, Haliru, Abdullahi S Ibrahim, Muhammad Sohaib Asghar, Mashaal Syed, Syed Anosh Ali Naqvi, Igor Borisovich Zabolotskikh, Konstantin Dmitrievich Zybin, Sergey Vasilevich Sinkov, Tatiana Sergeevna Musaeva, Marwa Ridha Amer, Mohammed Abdullah Bawazeer, Talal I. Dahhan, Eiad Kseibi, Abid Shahzad Butt, Syed Moazzum Khurshid, Muath Rabee, Mohammed Abujazar, Razan Alghunaim, Maal Abualkhair, Abeer Turki AlFirm, Razan K Alamoudi, Hassan M. AlSharif, Sarah A. Almazwaghi, Mohammed S Elsakran, Mohamed A Aid, Mouaz A Darwich, Omnia M Hagag, Salah A Ali, Alona rocacorba, Kathrine Supeña, Efren Ray Juane, Jenalyn Medina, Jowany Baduria, Mohammed A Almazyad, Mohammed I Alarifi, Jara M Macarambon, Ahmad Abdullah Bukhari, Hussain A. Albahrani, Kazi N Asfina, Kaltham M Aldossary, Predrag D Stevanovic, Dejan S Stojakov, Duska K Ignjatovic, Suzana C Bojic, Marina M Bobos, Irina B Nenadic, Milica S Zaric, Marko D Djuric, Vladimir R Djukic, Bojan Kovacevic, Jovana Bojicic, Marija Zdravkovic, Zoran Todorovic, Viseslav Popadic, Slobodan Klasnja, Santiago Y. Teruel, Belen C. Martin, Himat Sulaimonov, Firuza Khudonazarova, Nabi Bakhtibekov, Nekruz Jamshedov, Uluhan Sili, Huseyin Bilgin, Pinar Ay, Varsha P Gharpure, Usman Raheemi, Kenneth W. Dodd, Nicholas Goodmanson, Kathleen Hesse, Paige Bird, Chauncey Weinert, Nathan Schoenrade, Abdulrahman Altaher, Esmael Mayar, Matthew Aronson, Tyler Cooper, Monica Logan, Brianna Miner, Gisele Papo, Eric M. Siegal, Phyllis Runningen, Catherine A. St. Hill, Roman R. Melamed, David M. Tierney, Love A. Patel, Vino S. Raj, Barite U. Dawud, Narayana Mazumder, Abbey Sidebottom, Alena M. Guenther, Benjamin D. Krehbiel, Nova J. Schmitz, Stacy L. Jepsen, Abhijit A Raval, Andrea Franks, Katherine Irby, Ronald C. Sanders, Jr., Glenda Hefley, Anmol Kharbanda, Sunil Jhajhria, Zachary Fyffe, Stephen Capizzi, Bethany Alicie, Martha Green, Lori Crockarell, Amelia Drennan, Kathleen Dubuque, Tonya Fambrough, Nikole Gasaway, Briana Krantz, Peiman Nebi, Jan Orga, Margaret Serfass, Alina Simion, Kimberly Warren, Cassie Wheeler, CJ Woolman, Andrew S. Moyer, George M. Verghese, Andrea Sikora Newsome, Christy C. Forehand, Rebecca Bruning, Timothy W. Jones, Moldovan Sabov, Fatema Zaidi, Fiona Tissavirasingham, Dhatri Malipeddi, Jarrod M Mosier, Karen Lutrick, Beth Salvagio Campbell, Cathleen Wilson, Patrick Rivers, Jonathan Brinks, Mokenge Ndiva Mongoh, Boris Gilson, Donna Lee Armaignac, Don Parris, Maria Pilar Zuniga, Ilea Vargas, Viviana Boronat, Anneka Hutton, Navneet Kaur, Prashank Neupane, Nohemi Sadule-Rios, Lourdes M. Rojas, Aashish Neupane, Priscilla Rivera, Carlos Valle Carlos, Gregory Vincent, Mahesh Amin, Mary E Schelle, Amanda Steadham, Christopher M Howard, Cameron McBride, Jocelyn Abraham, Orlando Garner, Katherine Richards, Keegan Collins, Preethi Antony, Sindhu Mathew, Valerie C. Danesh, Gueorgui Dubrocq, Amber L. Davis, Marissa J Hammers, ill M. McGahey, Amanda C. Farris, Elisa Priest, Robyn Korsmo, Lorie Fares, Kathy Skiles, Susan M. Shor, Kenya Burns, Corrie A Dowell, Melody Flores, Lindsay Newman, Debora A Wilk, Jason Ettlinger, Jaccallene Bomar, Himani Darji, Alejandro Arroliga, Alejandro C Arroliga, Corrie A. Dowell, Gabriela Hope Conzales, Debora A. Wilk, Paras B. Khandhar, Elizabeth Kring, Valerie M. Banner-Goodspeed, Somnath Bose, Lauren E. Kelly, Melisa Joseph, Marie McGourty, Krystal Capers, Benjamin Hoenig, Maria C. Karamourtopoulos, Anica C. Law, Elias N. Baedorf Kassis, Allan J. Walkey, Sushrut S. Waikar, Michael A. Garcia, Mia Colona, Zoe Kibbelaar, Michael Leong, Daniel Wallman, Kanupriya Soni, Jennifer Maccarone, Joshua Gilman, Ycar Devis, Joseph Chung, Munizay Paracha, David N. Lumelsky, Madeline DiLorenzo, Najla Abdurrahman, Shelsey Johnson, Andrew M. Hersh, Stephanie L Wachs, Brittany S. Swigger, Lauren A. Sattler, Michael N. Moulton, Kimberly Zammit, J Patrick, William McGrath, Maya Loeffler, R Chilbert, Aaron S. Miller, Edwin L. Anderson, Rosemary Nagy, Ravali R. Inja, Raghavendra Tirupathi, Alymer Tang, Arshad Safi, Cindy Green, Jackie Newell, Rayan E. Ihle, Shelda A. Martin, Elaine A. Davis, Katja M. Gist, Imran A Sayed, John Brinton, Larisa Strom, Kathleen Chiotos, Allison M. Blatz, Giyoung Lee, Ryan H. Burnett, Guy I. Sydney, Danielle M. Traynor, Karissa Nauert, Annika Gonzalez, Mariel Bagley, Anita Santpurkar, Salim Surani, Joshua White, Aftab Khan, Rahul Dhahwal, Sreekanth Cheruku, Farzin Ahmed, Christopher Deonarine, Ashley Jones, Mohammad-Ali Shaikh, David Preston, Jeanette Chin, Vidula Vachharajani, Abhijit Duggal, Prabalini Rajendram, Omar Mehkri, Siddharth Dugar, Michelle Biehl, Gretchen Sacha, Stuart Houltham, Alexander King, Kiran Ashok, Bryan Poynter, Mary Beukemann, Richard Rice, Susan Gole, Valerie Shaner, Adarsh Conjeevaram, Michelle Ferrari, Narendrakumar Alappan, Steven Minear, Jaime Hernandez-Montfort, Syed Sohaib Nasim, Ravi Sunderkrishnan, Debasis Sahoo, Patrick S. Milligan, Sandeep K. Gupta, Joy M. Koglin, Regina Gibson, Lana Johnson, Felicia Preston, Crimson Scott, Bethany Nungester, Steven K. Daugherty, Sam Atkinson, Kelly Shrimpton, Sidney Ontai, Brian Contreras, Uzoma Obinwanko, Nneka Amamasi, Amir Sharafi, Sarah Lee, Zahia Esber, Chetna Jinjvadia, Kimberly Welker, Francis M. Maguire, Jessica Timmer, Raquel R Bartz, Vijay Krishnamoorthy, Bryan Kraft, Aaron Pulsipher, Eugene Friedman, Sachin Mehta, Margit Kaufman, Gregg Lobel, Nisha Gandhi, Amr Abdelaty, Elizabeth Shaji, Kiana Lim, Juan Marte, Dani Ashley Sosa, David P. Yamane, Ivy Benjenk, Nivedita Prasanna, Smith F. Heavner-Sullivan, Prera J. Roth, Banu Sivaraj, Haley Fulton, Madison G Herin, Marissa Crum, Morgan E. Fretwell, Emily-Rose Zhou, Christine Waller, Kara Kallies, Jonean Thorsen, Alec Fitzsimmons, Haley Olsen, Heda R. Dapul, Sourabh Verma, Alan Salas, Ariel Daube, Michelle Korn, Michelle Ramirez, Logi Rajagopalan, Laura Santos, Orma Smalls, Atul Malhotra, Abdurrahman Husain, Qais Zawaydeh, J.H. Steuernagle, Steven Q. Davis, Valentina Jovic, Max Masuda, Amanda Hayes, Katharine Nault, Michael Smith, William Snow, Riley Liptak, Hannah Durant, Valerie Pendleton, Alay Nanavati, Risa Mrozowsk, LiManoj K Gupta, Franscene E. Oulds, Akshay Nandavar, Yuk Ming Liu, Sarah Zavala, Esther Shim, Ronald A. Reilkoff, Julia A. Heneghan, Sarah Eichen, Lexie Goertzen, Scott Rajala, Ghislaine Feussom, Ben Tang, Christine C. Junia, Robert Lichtenberg, Hasrat Sidhu, Diana Espinoza, Shelden Rodrigues, Maria Jose Zabala, Daniela Goyes, Ammu Susheela, Buddhi Hatharaliyadda, Naveen Rameshkumar, Amulya Kasireddy, Genessis Maldonado, Lisseth Beltran, Akshata Chaugule, Hassan Khan, Namrata Patil, Ruhi Patil, Rodrigo Cartin-Ceba, Ayan Sen, Amanda Palacios, Giyth M. Mahdi, Rahul Kashyap, Ognjen Gajic, Vikas Bansal, Aysun Tekin, Amos Lal, John C. O’Horo, Neha N. Deo, Mayank Sharma, Shahraz Qamar, Cory J. Kudrna, Juan Pablo Domecq Garces, Abigail T. La Nou, Marija Bogojevic, Devang Sanghavi, Pramod Guru, Karthik Gnanapandithan, Hollie Saunders, Zachary Fleissner, Juan Garcia, Alejandra Yu Lee Mateus, Siva Naga Yarrarapu, Syed Anjum Khan, Juan Pablo Domecq, Nitesh Kumar Jain, Thoyaja Koritala, Alexander Bastidas, Gabriela Orellana, Adriana Briceno Bierwirth, Eliana Milazzo, Juan Guillermo Sierra, Thao Dang, Amy B. Christie, Dennis W. Ashley, Rajani Adiga, Rahul S Nanchal, Paul A Bergl, Jennifer L Peterson, Travis Yamanaka, Nicholas A. Barreras, Michael Markos, Anita Fareeduddin, Rohan Mehta, Chakradhar Venkata, Miriam Engemann, Annamarie Mantese, Yasir Tarabichi, Adam Perzynski, Christine Wang, Dhatri Kotekal, Adriana C Briceno Bierwirth, Gabriela M Orellana, Gerardo Catalasan, Shohana Ahmed, Carlos F Matute, Ahmad Hamdan, Ivania Salinas, Genesis Del Nogal, Angel Tejada, Anna Eschler, Mary Hejna, Emily Lewandowski, Kristen Kusmierski, Clare Martin, Jen-Ting Chen, Aluko Hope, Zoe Tsagaris, Elise Ruen, Aram Hambardzumyan, Prithvi Sendi, Meghana Nadiger, Balagangadhar Totapally, Bhagat S. Aulakh, Jennifer A. Bandy, Lisa M. Kreps, Dawn R. Bollinger, Roger Scott Stienecker, Andre G. Melendez, Tressa A. Brunner, Sue M Budzon, Jessica L. Heffernan, Janelle M. Souder, Tracy L. Miller, Andrea G. Maisonneuve, Roberta E. Redfern, Jessica Shoemaker, Jennifer Micham, Lynn Kenney, Gabriel Naimy, Sara Utley, Holly Balcer, Kerry P. J. Pulver, Jennifer Yehle, Alicia Weeks, Terra Inman, Brian L. Delmonaco, Anthony Franklin, Mitchell Heath, Antonia L. Vilella, Sara B. Kutner, Kacie Clark, Danielle Moore, Shina Menon, John K McGuire, Deana Rich, Harry L. Anderson, III, Dixy Rajkumar, Ali Abunayla, Jerrilyn Heiter, Howard A. Zaren, Stephanie J. Smith, Grant C. Lewis, Lauren Seames, Cheryl Farlow, Judy Miller, Gloria Broadstreet, John Lin, Cindy Terrill, Brock Montgomery, Sydney Reyes, Summer Reyes, Alex Plattner, Anthony Martinez, Micheal Allison, Aniket Mittal, Rafael Ruiz, Aleta Skaanland, Robert Ross, Umang Patel, Jordesha Hodge, KrunalKumar Patel, Shivani Dalal, Himanshu Kavani, Sam Joseph, Michael A. Bernstein, Ian K. Goff, Matthew Naftilan, Amal Mathew, Deborah Williams, Sue Murdock, Maryanne Ducey, Kerianne Nelson, Paul K Mohabir, Connor G O’Brien, Komal Dasani, William Marx, Ioana Amzuta, Asad J. Choudhry, Mohammad T. Azam, Kristina L Carter, Michael A Olmos, Brittany M Parker, Julio Quintanilla, Tara A Craig, Brendon J Clough, Jeffrey T Jameson, Neha Gupta, Tracy L Jones, Shonda C Ayers, Amy B Harrell, Dr.Brent R Brown, Utpal S. Bhalala, Joshua Kuehne, Melinda Garcia, Morgan Beebe, Heather Herrera, Chris Fiack, Stephanie Guo, May Vawer, Beth Blackburn, Megan Edwards, Caleb Darby, Kristy Page, Amanda Brown, Jessie McAbee, Katherine A. Belden, Michael Baram, Devin M. Weber, Rosalie DePaola, Yuwei Xia, Hudson Carter, Aaron Tolley, Mark Steele, Laurie Kemble, Joshua L. Denson, A. Scott Gillet, Margo Brown, Rachael Stevens, Andrew Wetherbie, Kevin Tea, Mathew Moore, Benjamin J Sines, Thomas J Bice, Emily A. Vail, Susannah Nicholson, Rachelle B. Jonas, AnnaRose E. Dement, William Tang, Mark DeRosa, Robert E. Villarreal, Rajany V. Dy, Alfredo Iardino, Jill Sharma, Richard Czieki, Julia Christopher, Ryan Lacey, Marwan Mashina, Kushal Patel, Erica C. Bjornstad, Nancy M. Tofil, Scott House, Isabella Aldana, Nikhil K. Meena, Jose D. Caceres, Nikhil K Meena, Sarenthia M. Epps, Harmeen Goraya, Kelsey R. Besett, Ryan James, Lana Y. Abusalem, Akash K. Patel, Lana S Hasan, Dina Gomaa, Michael Goodman, Devin Wakefield, Anthony Spuzzillo, John O. Shinn, II, Azra Bihorac, Tezcan Ozrazgat Baslanti, George Omalay, Haleh Hashemighouchani, Julie S. Cupka, Matthew M Ruppert, Patrick W. McGonagill, Colette Galet, Janice Hubbard, David Wang, Lauren Allan, Aditya Badheka, Madhuradhar Chegondi, Usman Nazir, Garrett Rampon, Jake Riggle, Nathan Dismang, Vicki Montgomery, Janice Sullivan, Sarah Morris, Jennifer Nason, Roger A. Alvarez, Amarilys Alarcon-Calderon, Marie Anne Sosa, Sunita K. Mahabir, Mausam J. Patel, Pauline Park, Andrew Admon, Sinan Hanna, Rishi Chanderraj, Maria Pliakas, Ann Wolski, Jennifer Cirino, Dima Dandachi, Hariharan Regunath, Maraya N. Camazine, Grant. E. Geiger, Abdoulie O. Njai, Baraa M. Saad, Faraaz Ali Shah, Byron Chuan, Sagar L. Rawal, Manal Piracha, Joseph E. Tonna, Nicholas M. Levin, Kayte Suslavich, Rachel Tsolinas, Zachary T. Fica, Chloe R. Skidmore, Renee D. Stapleton, Anne E. Dixon, Olivia Johnson, Sara S. Ardren, Stephanie Burns, Anna Raymond, Erika Gonyaw, Kevin Hodgdon, Chloe Housenger, Benjamin Lin, Karen McQuesten, Heidi Pecott-Grimm, Julie Sweet, Sebastian Ventrone, Nita Khandelwal, T. Eoin West, Ellen S. Caldwell, Lara Lovelace-Macon, Navya Garimella, Denisse B. Dow, Murtaza Akhter, Rania Abdul Rahman, Mary Mulrow, Erin M. Wilfong, Kelsi Vela, Ashish K. Khanna, Lynne Harris, Bruce Cusson, Jacob Fowler, David Vaneenenaam, Glen McKinney, Imoh Udoh, Kathleen Johnson, Patrick G. Lyons, Andrew P Michelson, Sara S. Haluf, Lauren M. Lynch, Nguyet M. Nguyen, Aaron Steinberg, Nicholas Braus, Vishwanath Pattan, Jessica Papke, Ismail Jimada, Nida Mhid, and Samuel Chakola

Subjects
young adults, medicine.medical_specialty, Population, Observational Study, outcomes, coronavirus disease 2019, Interquartile range, Intensive care, Epidemiology, medicine, Young adult, education, Intensive care medicine, intensive care, education.field_of_study, business.industry, RC86-88.9, Retrospective cohort study, Medical emergencies. Critical care. Intensive care. First aid, General Medicine, Odds ratio, medicine.disease, Comorbidity, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, mortality risk, business
Abstract

Supplemental Digital Content is available in the text., IMPORTANCE: Even with its proclivity for older age, coronavirus disease 2019 has been shown to affect all age groups. However, there remains a lack of research focused primarily on the young adult population. OBJECTIVES: To describe the epidemiology and outcomes of coronavirus disease 2019 and identify the risk factors associated with critical illness and mortality in hospitalized young adults. DESIGN, SETTINGS, AND PARTICIPANTS: A retrospective cohort study of the Society of Critical Care Medicine’s Viral Infection and Respiratory Illness Universal Study registry. Patients 18–40 years old, hospitalized from coronavirus disease 2019 from March 2020 to April 2021, were included in the analysis. MAIN OUTCOMES AND MEASURES: Critical illness was defined as a composite of mortality and 21 predefined interventions and complications. Multivariable logistic regression was used to assess associations with critical illness and mortality. RESULTS: Data from 4,005 patients (152 centers, 19 countries, 18.6% non-U.S. patients) were analyzed. The median age was 32 years (interquartile range, 27–37 yr); 51% were female, 29.4% Hispanic, and 42.9% had obesity. Most patients (63.2%) had comorbidities, the most common being hypertension (14.5%) and diabetes (13.7%). Hospital and ICU mortality were 3.2% (129/4,005) and 8.3% (109/1,313), respectively. Critical illness occurred in 25% (n = 996), and 34.3% (n = 1,376) were admitted to the ICU. Older age (p = 0.03), male sex (adjusted odds ratio, 1.83 [95% CI, 1.2–2.6]), and obesity (adjusted odds ratio, 1.6 [95% CI, 1.1–2.4]) were associated with hospital mortality. In addition to the above factors, the presence of any comorbidity was associated with critical illness from coronavirus disease 2019. Multiple sensitivity analyses, including analysis with U.S. patients only and patients admitted to high-volume sites, showed similar risk factors. CONCLUSIONS: Among hospitalized young adults, obese males with comorbidities are at higher risk of developing critical illness or dying from coronavirus disease 2019.

Published
2021

13. Multisystem Inflammatory Syndrome in Children — Initial Therapy and Outcomes

Author

Nancy Murray, Jane W. Newburger, Janet R. Hume, Stephanie P Schwartz, Charlotte V. Hobbs, Leora R. Feldstein, Katharine N. Clouser, Vijaya L. Soma, Tamara T. Bradford, Mark W. Hall, Julie C. Fitzgerald, Steven M. Horwitz, Michele Kong, Laura L. Loftis, Gwenn E. McLaughlin, Christopher L. Carroll, Lincoln S. Smith, Mary Beth F. Son, Charles E. Rose, Sule Doymaz, Margaret M. Newhams, Sabrina M. Heidemann, John S. Giuliano, Elizabeth H. Mack, Christopher J. Babbitt, Natalie Z. Cvijanovich, Phoebe H. Yager, Aalok R. Singh, Katherine Irby, Cameron C. Young, Adrienne G. Randolph, Mia Maamari, Vicki L. Montgomery, Natasha B. Halasa, Kevin G. Friedman, Becky J. Riggs, Manish M. Patel, Bria M. Coates, Aline B Maddux, Keiko M. Tarquinio, Michael A. Keenaghan, Courtney M. Rowan, and Jennifer E. Schuster

Subjects
Biological Products, Pediatrics, medicine.medical_specialty, 2019-20 coronavirus outbreak, business.industry, Immunoglobulins, Intravenous, General Medicine, medicine.disease, Combination drug therapy, Systemic inflammatory response syndrome, Pharmacotherapy, otorhinolaryngologic diseases, Humans, Immunologic Factors, Medicine, Combined Modality Therapy, Original Article, Immunotherapy, Young adult, business, Initial therapy, Glucocorticoids, Cohort study
Abstract

Background The assessment of real-world effectiveness of immunomodulatory medications for multisystem inflammatory syndrome in children (MIS-C) may guide therapy. Methods We analyzed surveillance data on inpatients younger than 21 years of age who had MIS-C and were admitted to 1 of 58 U.S. hospitals between March 15 and October 31, 2020. The effectiveness of initial immunomodulatory therapy (day 0, indicating the first day any such therapy for MIS-C was given) with intravenous immune globulin (IVIG) plus glucocorticoids, as compared with IVIG alone, was evaluated with propensity-score matching and inverse probability weighting, with adjustment for baseline MIS-C severity and demographic characteristics. The primary outcome was cardiovascular dysfunction (a composite of left ventricular dysfunction or shock resulting in the use of vasopressors) on or after day 2. Secondary outcomes included the components of the primary outcome, the receipt of adjunctive treatment (glucocorticoids in patients not already receiving glucocorticoids on day 0, a biologic, or a second dose of IVIG) on or after day 1, and persistent or recurrent fever on or after day 2. Results A total of 518 patients with MIS-C (median age, 8.7 years) received at least one immunomodulatory therapy; 75% had been previously healthy, and 9 died. In the propensity-score–matched analysis, initial treatment with IVIG plus glucocorticoids (103 patients) was associated with a lower risk of cardiovascular dysfunction on or after day 2 than IVIG alone (103 patients) (17% vs. 31%; risk ratio, 0.56; 95% confidence interval [CI], 0.34 to 0.94). The risks of the components of the composite outcome were also lower among those who received IVIG plus glucocorticoids: left ventricular dysfunction occurred in 8% and 17% of the patients, respectively (risk ratio, 0.46; 95% CI, 0.19 to 1.15), and shock resulting in vasopressor use in 13% and 24% (risk ratio, 0.54; 95% CI, 0.29 to 1.00). The use of adjunctive therapy was lower among patients who received IVIG plus glucocorticoids than among those who received IVIG alone (34% vs. 70%; risk ratio, 0.49; 95% CI, 0.36 to 0.65), but the risk of fever was unaffected (31% and 40%, respectively; risk ratio, 0.78; 95% CI, 0.53 to 1.13). The inverse-probability-weighted analysis confirmed the results of the propensity-score–matched analysis. Conclusions Among children and adolescents with MIS-C, initial treatment with IVIG plus glucocorticoids was associated with a lower risk of new or persistent cardiovascular dysfunction than IVIG alone. (Funded by the Centers for Disease Control and Prevention.)

Published
2021

14. Characteristics and Outcomes of US Children and Adolescents With Multisystem Inflammatory Syndrome in Children (MIS-C) Compared With Severe Acute COVID-19

Author

Mark W Tenforde, Cindy Bowens, Elizabeth H. Mack, Ashley M. Jackson, Gwenn E. McLaughlin, Sule Doymaz, Erica Billig Rose, Mark W. Hall, Stephanie P Schwartz, Sheemon P. Zackai, Keiko M. Tarquinio, Katherine Irby, Bria M. Coates, Julie C. Fitzgerald, Becky J. Riggs, Simon Li, Ryan W. Carroll, Heda Dapul, Tracie C. Walker, Michele Kong, Margaret M Newhams, Christopher Babbitt, Natalie Z. Cvijanovich, Sabrina M. Heidemann, Katharine N. Clouser, Kevin G. Friedman, Aalok R. Singh, Mary Beth F. Son, Laura Loftis, Cameron C. Young, Jane W. Newburger, Courtney M. Rowan, Ryan Nofziger, Shira J. Gertz, Vijaya L. Soma, Kari Wellnitz, John S. Giuliano, Manish M. Patel, Jennifer E. Schuster, Steven M. Horwitz, Lincoln S. Smith, Leora R. Feldstein, Tamara T. Bradford, Aline B Maddux, Adrienne G. Randolph, Peter M. Mourani, Janet R. Hume, Mia Maamari, Natasha B. Halasa, and Charlotte V. Hobbs

Subjects
Male, medicine.medical_specialty, Adolescent, Mucocutaneous zone, Intensive Care Units, Pediatric, 01 natural sciences, Diagnosis, Differential, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Internal medicine, medicine, Humans, 030212 general & internal medicine, 0101 mathematics, Neutrophil to lymphocyte ratio, Young adult, Respiratory system, Child, Original Investigation, business.industry, 010102 general mathematics, Absolute risk reduction, Age Factors, Patient Acuity, COVID-19, Cardiorespiratory fitness, Stroke Volume, General Medicine, medicine.disease, Systemic Inflammatory Response Syndrome, United States, Systemic inflammatory response syndrome, Relative risk, Child, Preschool, Regression Analysis, Female, business, Biomarkers
Abstract

IMPORTANCE: Refinement of criteria for multisystem inflammatory syndrome in children (MIS-C) may inform efforts to improve health outcomes. OBJECTIVE: To compare clinical characteristics and outcomes of children and adolescents with MIS-C vs those with severe coronavirus disease 2019 (COVID-19). SETTING, DESIGN, AND PARTICIPANTS: Case series of 1116 patients aged younger than 21 years hospitalized between March 15 and October 31, 2020, at 66 US hospitals in 31 states. Final date of follow-up was January 5, 2021. Patients with MIS-C had fever, inflammation, multisystem involvement, and positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcriptase–polymerase chain reaction (RT-PCR) or antibody test results or recent exposure with no alternate diagnosis. Patients with COVID-19 had positive RT-PCR test results and severe organ system involvement. EXPOSURE: SARS-CoV-2. MAIN OUTCOMES AND MEASURES: Presenting symptoms, organ system complications, laboratory biomarkers, interventions, and clinical outcomes. Multivariable regression was used to compute adjusted risk ratios (aRRs) of factors associated with MIS-C vs COVID-19. RESULTS: Of 1116 patients (median age, 9.7 years; 45% female), 539 (48%) were diagnosed with MIS-C and 577 (52%) with COVID-19. Compared with patients with COVID-19, patients with MIS-C were more likely to be 6 to 12 years old (40.8% vs 19.4%; absolute risk difference [RD], 21.4% [95% CI, 16.1%-26.7%]; aRR, 1.51 [95% CI, 1.33-1.72] vs 0-5 years) and non-Hispanic Black (32.3% vs 21.5%; RD, 10.8% [95% CI, 5.6%-16.0%]; aRR, 1.43 [95% CI, 1.17-1.76] vs White). Compared with patients with COVID-19, patients with MIS-C were more likely to have cardiorespiratory involvement (56.0% vs 8.8%; RD, 47.2% [95% CI, 42.4%-52.0%]; aRR, 2.99 [95% CI, 2.55-3.50] vs respiratory involvement), cardiovascular without respiratory involvement (10.6% vs 2.9%; RD, 7.7% [95% CI, 4.7%-10.6%]; aRR, 2.49 [95% CI, 2.05-3.02] vs respiratory involvement), and mucocutaneous without cardiorespiratory involvement (7.1% vs 2.3%; RD, 4.8% [95% CI, 2.3%-7.3%]; aRR, 2.29 [95% CI, 1.84-2.85] vs respiratory involvement). Patients with MIS-C had higher neutrophil to lymphocyte ratio (median, 6.4 vs 2.7, P

Published
2021

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