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1.
Clin Infect Dis ; 2022 Jun 19.
Article in English | MEDLINE | ID: covidwho-1901139

ABSTRACT

BACKGROUND: Clinical differences between critical illness from influenza infection versus coronavirus disease 2019 (COVID-19) have not been well characterized in pediatric patients. METHODS: We compared U.S. children (8 months to 17 years) admitted to the intensive care or high acuity unit with influenza (17 hospitals, 12/19/2019-3/9/2020) or COVID-19 (52 hospitals, 3/15/2020-12/31/2020). We compared demographics, underlying conditions, clinical presentation, severity, and outcomes. Using mixed-effects models, we assessed the odds of death or requiring life-support for influenza versus COVID-19 after adjustment for age, sex, race and Hispanic origin, and underlying conditions including obesity. RESULTS: Children with influenza (n = 179) were younger than those with COVID-19 (n = 381; median 5.2 vs. 13.8 years), less likely to be non-Hispanic black (14.5% vs. 27.6%) or Hispanic (24.0% vs. 36.2%), and less likely to have ≥1 underlying condition (66.4% vs. 78.5%) or be obese (21.4% vs. 42.2%). They were similarly likely to require invasive mechanical ventilation (both 30.2%), vasopressor support (19.6% and 19.9%), or extracorporeal membrane oxygenation (2.2% and 2.9%). Four children with influenza (2.2%) and 11 children with COVID-19 (2.9%) died. The odds of death or requiring life-support in children with influenza vs. COVID-19 were similar (adjusted odds ratio, 1.30 [95% CI: 0.78-2.15; P = 0.32]). Median duration of hospital stay was shorter for influenza than COVID-19 (5 versus 7 days). CONCLUSIONS: Despite differences in demographics and clinical characteristics of children with influenza or COVID-19, the frequency of life-threatening complications was similar. Our findings highlight the importance of implementing prevention measures to reduce transmission and disease severity of influenza and COVID-19.

2.
J Pediatr ; 245: 102-110.e2, 2022 06.
Article in English | MEDLINE | ID: covidwho-1773536

ABSTRACT

OBJECTIVE: To identify subgroups likely to benefit from monoclonal antibody and antiviral therapy by evaluating the relationship between comorbidities and hospitalization among US adolescents with symptomatic coronavirus disease 2019 (COVID-19). STUDY DESIGN: We analyzed the relationship between presence of comorbidities and need for hospitalization within 28 days of COVID-19 diagnosis for adolescents aged 12-17 years listed in the Pediatric COVID-19 US registry, a multicenter retrospective cohort of US pediatric patients with COVID-19. Comorbidities assessed included obesity, chronic kidney disease (CKD), diabetes, immunosuppressive disease or treatment, sickle cell disease (SCD), heart disease, neurologic disease/neurodevelopmental disorders, and pulmonary disease (excluding patients with mild asthma). We used multivariable logistic regression to determine race/ethnicity-adjusted associations between comorbidities and hospitalization. RESULTS: A total of 1877 patients met our inclusion criteria, of whom 284 (15%) were hospitalized within 28 days of their COVID-19 diagnosis. In a race/ethnicity-adjusted model, the following comorbidities were independently associated with increased odds of hospitalization: SCD (aOR, 6.9; 95% CI, 3.0-15.9), immunocompromising condition (aOR, 6.4; 95% CI, 3.8-10.8), obesity (aOR, 3.2; 95% CI, 2.1-4.9), diabetes (aOR, 3.0; 95% CI, 1.4-6.2), neurologic disease (aOR, 2.8; 95% CI, 1.8-4.3), and pulmonary disease (excluding mild asthma) (aOR, 1.9; 95% CI, 1.2-3.1). Heart disease and CKD were not independently associated with hospitalization. CONCLUSIONS: SCD, immunocompromising conditions, obesity, diabetes, neurologic disease, and pulmonary disease (excluding mild asthma) were associated with hospitalization for symptomatic COVID-19. Adolescents with acute COVID-19 and these comorbidities should be prioritized for consideration of therapy to avert hospitalization.


Subject(s)
Asthma , COVID-19 , Diabetes Mellitus , Heart Diseases , Renal Insufficiency, Chronic , Adolescent , Asthma/epidemiology , Asthma/therapy , COVID-19/epidemiology , COVID-19/therapy , COVID-19 Testing , Child , Comorbidity , Diabetes Mellitus/epidemiology , Hospitalization , Humans , Obesity/epidemiology , Retrospective Studies , Risk Factors , SARS-CoV-2
3.
The Journal of pediatrics ; 2022.
Article in English | EuropePMC | ID: covidwho-1710571

ABSTRACT

Objectives To identify subgroups likely to benefit from monoclonal antibody and antiviral therapy, we evaluated the relationship between comorbidities and hospitalization among US adolescents with symptomatic COVID-19. Study design We analyzed the relationship between presence of comorbidities and need for hospitalization within 28 days of COVID-19 diagnosis for adolescents 12-17 years old in the Pediatric COVID-19 U.S. registry, a multicenter retrospective cohort of US pediatric patients with COVID-19. Comorbidities assessed included obesity, chronic kidney disease (CKD), diabetes, immunosuppressive disease or treatment, sickle cell disease (SCD), heart disease, neurologic disease/neurodevelopmental disorders, and pulmonary disease (excluding patients with mild asthma). We used multivariable logistic regression to determine race/ethnicity-adjusted associations between comorbidities and hospitalization. Results 1877 patients met inclusion criteria, of whom 284 (15%) were hospitalized within 28 days of COVID-19 diagnosis. In a race/ethnicity-adjusted model, the following comorbidities were independently associated with increased odds of hospitalization: SCD (aOR 6.9 [3.0-15.9]), immunocompromising condition (aOR 6.4 [3.8-10.8]), obesity (aOR 3.2 [2.1-4.9]), diabetes (aOR 3.0 [1.4-6.2]), neurologic disease (aOR 2.8 [1.8-4.3]), and pulmonary disease (excluding mild asthma) (aOR 1.9 [1.2-3.1]). Heart disease and chronic kidney disease were not independently associated with hospitalization. Conclusions SCD, immunocompromising conditions, obesity, diabetes, neurologic disease, and pulmonary disease (excluding mild asthma) were associated with hospitalization for symptomatic COVID-19. Adolescents with acute COVID-19 and these comorbidities should be prioritized for consideration of therapy to avert hospitalization.

4.
J Pediatric Infect Dis Soc ; 11(5): 177-185, 2022 May 30.
Article in English | MEDLINE | ID: covidwho-1672222

ABSTRACT

BACKGROUND: Starting in November 2020, the US Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for multiple novel virus-neutralizing monoclonal antibody therapies, including bamlanivimab monotherapy (now revoked), bamlanivimab and etesivimab, casirivimab and imdevimab (REGEN-COV), and sotrovimab, for treatment or postexposure prophylaxis of Coronavirus disease 2019 (COVID-19) in adolescents (≥12 years of age) and adults with certain high-risk conditions. Previous guidance is now updated based on new evidence and clinical experience. METHODS: A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacotherapy, and pediatric critical care medicine from 18 geographically diverse US institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on a review of the best available evidence and expert opinion. RESULTS: The course of COVID-19 in children and adolescents is typically mild, though more severe disease is occasionally observed. Evidence supporting risk stratification is incomplete. Randomized controlled trials have demonstrated the benefit of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-specific monoclonal antibody therapies in adults, but data on safety and efficacy in children or adolescents are limited. Potential harms associated with infusion reactions or anaphylaxis are reportedly low in adults. CONCLUSIONS: Based on evidence available as of August 31, 2021, the panel suggests a risk-based approach to administration of SARS-CoV-2 monoclonal antibody therapy. Therapy is suggested for the treatment of mild to moderate COVID-19 in adolescents (≥12 years of age) at the highest risk of progression to hospitalization or severe disease. Therapeutic decision-making about those at moderate risk of severe disease should be individualized. Use as postexposure prophylaxis could be considered for those at the highest risk who have a high-risk exposure but are not yet diagnosed with COVID-19. Clinicians and health systems should ensure safe and timely implementation of these therapeutics that does not exacerbate existing healthcare disparities.


Subject(s)
COVID-19 , Practice Guidelines as Topic , Adolescent , Adult , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized , Antibodies, Neutralizing , Antibodies, Viral , COVID-19/drug therapy , Child , Drug Combinations , Humans , SARS-CoV-2
6.
Open forum infectious diseases ; 8(Suppl 1):S393-S394, 2021.
Article in English | EuropePMC | ID: covidwho-1564073

ABSTRACT

Background Most adolescents (age 12-17 years) with COVID-19 have mild disease. However, certain comorbidities may be risk factors for disease progression, and hospitalization rates for this age group have increased. Adolescents and adults with mild to moderate COVID-19 are eligible for monoclonal antibody therapy. To identify subgroups likely to benefit from this intervention, we evaluated the relationship between comorbidities and need for hospitalization in US adolescents presenting with mild to moderate COVID-19. Methods We analyzed presence of comorbidities and need for hospitalization within 28 days of diagnosis for adolescents in the PIDTRAN registry, a multicenter retrospective cohort of US pediatric patients with COVID-19. Comorbidities assessed included obesity, chronic kidney disease (CKD), diabetes (DM), immunosuppressive disease or treatment (IS), sickle cell disease (SCD), congenital/acquired heart disease (CHD), neurologic disease/neurodevelopmental disorders (ND), medical-related technology dependence (MTD), and pulmonary disease requiring daily inhaled corticosteroids (PD). We used multivariable logistic regression to determine race/ethnicity-adjusted associations between comorbidities and hospitalization. Results 1574 patients met inclusion criteria, of whom 180 (11.4%) were hospitalized within 28 days of COVID-19 diagnosis. In a race/ethnicity-adjusted model, the following comorbidities were independently associated with increased odds of hospitalization: IS (OR 10.8 [95%CI 5.4 – 21.7]);CKD (OR 5.1 [95%CI 1.0 – 25.6]);DM (OR 4.2 [95%CI 1.7 – 10.6]);SCD (OR 3.4 [95%CI 1.1 – 10.6]). ND (OR 3.0 [95%CI 1.7 – 5.4]);and obesity (OR 2.0 [95%CI 1.1 – 3.9]). Notably, CHD, MTD, and PD were not independently associated with hospitalization. There was no effect modification of race/ethnicity on the association between obesity or DM and hospitalization. Table 1: Characteristics of adolescents in our cohort Figure 1. Association between comorbidities and hospitalization. Model 1: comorbidities only. Model 2: comorbidities, adjusted for race/ethnicity. Abbreviations: CKD – chronic kidney disease;SCD – sickle cell disease;ICS – inhaled corticosteroids. Conclusion IS, CKD, DM, SCD, ND, and obesity were associated with increased odds of hospitalization in adolescents presenting with mild to moderate COVID-19. Adolescents with these comorbidities should be prioritized for consideration of treatment with monoclonal antibodies. Disclosures Gabriella S. Lamb, MD, MPH, Nothing to disclose

7.
J Pediatric Infect Dis Soc ; 10(5): 629-634, 2021 May 28.
Article in English | MEDLINE | ID: covidwho-1272968

ABSTRACT

BACKGROUND: In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for 2 novel virus-neutralizing monoclonal antibody therapies, bamlanivimab and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products. METHODS: A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion. RESULTS: The course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high-risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis. CONCLUSIONS: Based on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence and ensure the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Pneumonia, Viral/drug therapy , Adolescent , Antibodies, Monoclonal, Humanized , COVID-19/epidemiology , Child , Drug Approval , Female , Humans , Male , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , SARS-CoV-2 , United States/epidemiology , United States Food and Drug Administration
8.
J Pediatric Infect Dis Soc ; 10(1): 34-48, 2021 Feb 13.
Article in English | MEDLINE | ID: covidwho-1081066

ABSTRACT

BACKGROUND: Although coronavirus disease 2019 (COVID-19) is a mild infection in most children, a small proportion develop severe or critical illness. Data describing agents with potential antiviral activity continue to expand such that updated guidance is needed regarding use of these agents in children. METHODS: A panel of pediatric infectious diseases physicians and pharmacists from 20 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a set of guidance statements was developed and refined based on review of the best available evidence and expert opinion. RESULTS: Given the typically mild course of COVID-19 in children, supportive care alone is suggested for most cases. For children with severe illness, defined as a supplemental oxygen requirement without need for noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), remdesivir is suggested, preferably as part of a clinical trial if available. Remdesivir should also be considered for critically ill children requiring invasive or noninvasive mechanical ventilation or ECMO. A duration of 5 days is appropriate for most patients. The panel recommends against the use of hydroxychloroquine or lopinavir-ritonavir (or other protease inhibitors) for COVID-19 in children. CONCLUSIONS: Antiviral therapy for COVID-19 is not necessary for the great majority of pediatric patients. For children with severe or critical disease, this guidance offers an approach for decision-making regarding use of remdesivir.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Adenosine Monophosphate/analogs & derivatives , Adenosine Monophosphate/therapeutic use , Alanine/analogs & derivatives , Alanine/therapeutic use , COVID-19/therapy , Child , Evidence-Based Medicine , Humans , Immunocompromised Host , Risk Factors , Severity of Illness Index , Systemic Inflammatory Response Syndrome/drug therapy
9.
J Pediatric Infect Dis Soc ; 9(6): 701-715, 2020 Dec 31.
Article in English | MEDLINE | ID: covidwho-1072375

ABSTRACT

BACKGROUND: Although coronavirus disease 2019 (COVID-19) is mild in nearly all children, a small proportion of pediatric patients develop severe or critical illness. Guidance is therefore needed regarding use of agents with potential activity against severe acute respiratory syndrome coronavirus 2 in pediatrics. METHODS: A panel of pediatric infectious diseases physicians and pharmacists from 18 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a set of guidance statements was developed and refined based on review of best available evidence and expert opinion. RESULTS: Given the typically mild course of pediatric COVID-19, supportive care alone is suggested for the overwhelming majority of cases. The panel suggests a decision-making framework for antiviral therapy that weighs risks and benefits based on disease severity as indicated by respiratory support needs, with consideration on a case-by-case basis of potential pediatric risk factors for disease progression. If an antiviral is used, the panel suggests remdesivir as the preferred agent. Hydroxychloroquine could be considered for patients who are not candidates for remdesivir or when remdesivir is not available. Antivirals should preferably be used as part of a clinical trial if available. CONCLUSIONS: Antiviral therapy for COVID-19 is not necessary for the great majority of pediatric patients. For those rare cases of severe or critical disease, this guidance offers an approach for decision-making regarding antivirals, informed by available data. As evidence continues to evolve rapidly, the need for updates to the guidance is anticipated.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Child , Humans , Risk Assessment , Severity of Illness Index
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