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Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents

Wolf, Joshua; Abzug, Mark J; Wattier, Rachel L; Sue, Paul K; Vora, Surabhi B; Zachariah, Philip; Dulek, Daniel E; Waghmare, Alpana; Olivero, Rosemary; Downes, Kevin J; James, Scott H; Pinninti, Swetha G; Yarbrough, April; Aldrich, Margaret L; MacBrayne, Christine E; Soma, Vijaya L; Grapentine, Steven P; Oliveira, Carlos R; Hayes, Molly; Kimberlin, David W; Jones, Sarah B; Bio, Laura L; Morton, Theodore H; Hankins, Jane S; MarÏŒn-Alfaro, Gabriella M; Timberlake, Kathryn; Young, Jennifer L; Orscheln, Rachel C; Schwenk, Hayden T; Goldman, David L; Groves, Helen E; Huskins, W Charles; Rajapakse, Nipunie S; Lamb, Gabriella S; Tribble, Alison C; Lloyd, Elizabeth E; Hersh, Adam L; Thorell, Emily A; Ratner, Adam J; Chiotos, Kathleen; Nakamura, Mari M
BACKGROUND:In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for two novel virus-neutralizing monoclonal antibody therapies, bamlanivimab, and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate 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 implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.
PMID: 33388760
ISSN: 2048-7207
CID: 4738392

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

Feldstein, Leora R; Tenforde, Mark W; Friedman, Kevin G; Newhams, Margaret; Rose, Erica Billig; Dapul, Heda; Soma, Vijaya L; Maddux, Aline B; Mourani, Peter M; Bowens, Cindy; Maamari, Mia; Hall, Mark W; Riggs, Becky J; Giuliano, John S; Singh, Aalok R; Li, Simon; Kong, Michele; Schuster, Jennifer E; McLaughlin, Gwenn E; Schwartz, Stephanie P; Walker, Tracie C; Loftis, Laura L; Hobbs, Charlotte V; Halasa, Natasha B; Doymaz, Sule; Babbitt, Christopher J; Hume, Janet R; Gertz, Shira J; Irby, Katherine; Clouser, Katharine N; Cvijanovich, Natalie Z; Bradford, Tamara T; Smith, Lincoln S; Heidemann, Sabrina M; Zackai, Sheemon P; Wellnitz, Kari; Nofziger, Ryan A; Horwitz, Steven M; Carroll, Ryan W; Rowan, Courtney M; Tarquinio, Keiko M; Mack, Elizabeth H; Fitzgerald, Julie C; Coates, Bria M; Jackson, Ashley M; Young, Cameron C; Son, Mary Beth F; Patel, Manish M; Newburger, Jane W; Randolph, Adrienne G
Importance/UNASSIGNED:Refinement of criteria for multisystem inflammatory syndrome in children (MIS-C) may inform efforts to improve health outcomes. Objective/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED:SARS-CoV-2. Main Outcomes and Measures/UNASSIGNED: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/UNASSIGNED: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 < .001), higher C-reactive protein level (median, 152 mg/L vs 33 mg/L; P < .001), and lower platelet count (<150 ×103 cells/μL [212/523 {41%} vs 84/486 {17%}, P < .001]). A total of 398 patients (73.8%) with MIS-C and 253 (43.8%) with COVID-19 were admitted to the intensive care unit, and 10 (1.9%) with MIS-C and 8 (1.4%) with COVID-19 died during hospitalization. Among patients with MIS-C with reduced left ventricular systolic function (172/503, 34.2%) and coronary artery aneurysm (57/424, 13.4%), an estimated 91.0% (95% CI, 86.0%-94.7%) and 79.1% (95% CI, 67.1%-89.1%), respectively, normalized within 30 days. Conclusions and Relevance/UNASSIGNED:This case series of patients with MIS-C and with COVID-19 identified patterns of clinical presentation and organ system involvement. These patterns may help differentiate between MIS-C and COVID-19.
PMID: 33625505
ISSN: 1538-3598
CID: 4794702

Multicenter interim guidance on use of antivirals for children with COVID-19/SARS-CoV-2

Chiotos, Kathleen; Hayes, Molly; Kimberlin, David W; Jones, Sarah B; James, Scott H; Pinninti, Swetha G; Yarbrough, April; Abzug, Mark J; MacBrayne, Christine E; Soma, Vijaya L; Dulek, Daniel E; Vora, Surabhi B; Waghmare, Alpana; Wolf, Joshua; Olivero, Rosemary; Grapentine, Steven; Wattier, Rachel L; Bio, Laura; Cross, Shane J; Dillman, Nicholas O; Downes, Kevin J; Oliveira, Carlos R; Timberlake, Kathryn; Young, Jennifer; Orscheln, Rachel C; Tamma, Pranita D; Schwenk, Hayden T; Zachariah, Philip; Aldrich, Margaret L; Goldman, David L; Groves, Helen E; Rajapakse, Nipunie S; Lamb, Gabriella S; Tribble, Alison C; Hersh, Adam L; Thorell, Emily A; Denison, Mark R; Ratner, Adam J; Newland, Jason G; Nakamura, Mari M
BACKGROUND:Although Coronavirus Disease 2019 (COVID-19) is a mild infection in most children, a small proportion develop severe or critical illness. Data evaluating 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 non-invasive or invasive mechanical ventilation or extra-corporeal 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 non-invasive 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.
PMID: 32918548
ISSN: 2048-7207
CID: 4592272

Multisystem inflammatory syndrome in children

Soma, Vijaya L; Shust, Gail F; Ratner, Adam J
PURPOSE OF REVIEW/OBJECTIVE:Here we summarize current knowledge about multisystem inflammatory syndrome in children (MIS-C), a presumed postinfectious inflammatory condition that has emerged as an important COVID-19-associated complication, to help clinicians identify and manage cases. RECENT FINDINGS/RESULTS:Clinical presentation of MIS-C is dominated by significant inflammation. Fever, gastrointestinal symptoms, cardiac dysfunction, and hypotension are common features. Kawasaki disease-like findings are common, but epidemiologic data and recent mechanistic studies suggest that distinct inflammatory pathways mediate Kawasaki disease and MIS-C. A broad diagnostic approach is recommended, given overlapping presentations between MIS-C and many other disease processes. Current management of MIS-C is highly variable, depending on illness severity, and can range from supportive care to aggressive immune modulation. A multidisciplinary approach with early involvement of multiple pediatric subspecialists is recommended for complicated cases. SUMMARY/CONCLUSIONS:Several studies have described the clinical manifestations of MIS-C, but definitive diagnosis remains challenging. Robust information about long-term outcomes awaits further study, as do immunologic data to refine diagnostic and therapeutic strategies.
PMID: 33278107
ISSN: 1531-698x
CID: 4708332

Multicenter initial guidance on use of antivirals for children with COVID-19/SARS-CoV-2

Chiotos, Kathleen; Hayes, Molly; Kimberlin, David W; Jones, Sarah B; James, Scott H; Pinninti, Swetha G; Yarbrough, April; Abzug, Mark J; MacBrayne, Christine E; Soma, Vijaya L; Dulek, Daniel E; Vora, Surabhi B; Waghmare, Alpana; Wolf, Joshua; Olivero, Rosemary; Grapentine, Steven; Wattier, Rachel L; Bio, Laura; Cross, Shane J; Dillman, Nicholas O; Downes, Kevin J; Timberlake, Kathryn; Young, Jennifer; Orscheln, Rachel C; Tamma, Pranita D; Schwenk, Hayden T; Zachariah, Philip; Aldrich, Margaret; Goldman, David L; Groves, Helen E; Lamb, Gabriella S; Tribble, Alison C; Hersh, Adam L; Thorell, Emily A; Denison, Mark R; Ratner, Adam J; Newland, Jason G; Nakamura, Mari M
BACKGROUND:Although Coronavirus Disease 2019 (COVID-19) is mild in nearly all children, a small proportion of pediatric patients develops 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 children who develop severe or critical disease, this guidance offer 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.
PMID: 32318706
ISSN: 2048-7207
CID: 4397102

Very low incidence of <i>Clostridioides difficile</i> infection in pediatric sickle cell disease patients

Lee, Philip; Sinha, Arpan A; Soma, Vijaya L; Cruz, Carlos; Wang, Tao; Aroniadis, Olga; Herold, Betsy C; Frenette, Paul S; Goldman, David L; Manwani, Deepa
PMID: 33054107
ISSN: 1592-8721
CID: 4641552

Differences in Gut Microbiome in Hospitalized Immunocompetent vs. Immunocompromised Children, Including Those With Sickle Cell Disease

Mohandas, Sindhu; Soma, Vijaya L; Tran, Thi Dong Binh; Sodergren, Erica; Ambooken, Tresa; Goldman, David L; Weinstock, George; Herold, Betsy C
Background: Gut microbial diversity and composition play important roles in health. This cross-sectional study was designed to test the hypothesis that hospitalized children who may be relatively immunocompromised (IC), defined as those with cancer, sickle cell disease (SCD), transplantation, or receiving immunosuppressive therapy) would have decreased microbial diversity, increased Clostridioides difficile colonization and different species composition compared to non-immunocompromised (Non-IC) children admitted to the same pediatric unit. Methods: A stool sample was obtained within 72 h of admission to a single unit at The Children's Hospital at Montefiore, Bronx, NY from March 2016 to February 2017 and the microbiome assessed by 16S rRNA sequencing. C. difficile colonization was assessed by glutamate dehydrogenase antigen and toxin polymerase chain reaction assays. Results: Stool samples were obtained from 69 IC (32 SCD, 19 cancer, 9 transplantation and 9 other) and 37 Non-IC patients. There were no significant differences in microbial alpha diversity and C. difficile colonization comparing IC vs. non-IC patients. Lower alpha diversity, however, was independently associated with the use of proton pump inhibitors or antibiotics, including prophylactic penicillin in patients with SCD. Differences in specific species abundances were observed when comparing IC vs. non-IC patients, particularly children with SCD. Non-IC patients had increased abundance of commensals associated with health including Alistipes putredinis, Alistipes ihumii, Roseburia inulinivorans, Roseburia intestinalis, and Ruminococcus albus (p < 0.005). Conclusions: Antibiotics and proton pump inhibitors, which were more commonly used in IC children, were identified as risk factors for lower microbial diversity. Non-IC patients had higher abundance of several bacterial species associated with health. Longitudinal studies are needed to determine the clinical significance of these differences in gut microbiome.
PMCID:7690629
PMID: 33282798
ISSN: 2296-2360
CID: 4708512

Similar proportions of stool specimens from hospitalized children with and without diarrhea test positive for Clostridium difficile

Leibowitz, Jill; Soma, Vijaya L; Rosen, Lisa; Ginocchio, Christine C; Rubin, Lorry G
BACKGROUND:Many laboratories use polymerase chain reaction (PCR)-based assays to detect the Clostridium difficile toxin B gene (tcdB) in stool. However, PCR testing experience in pediatric patients is limited. We compared the detection of C. difficile by PCR in hospitalized children with and without diarrhea. METHODS:Stool samples from patients aged 1-18 years with diarrhea (symptomatic) and from patients without diarrhea (asymptomatic) were tested for C. difficile tcdB using a commercial PCR assay. Samples were cultured for C. difficile using standard techniques with tcdB PCR and cytotoxicity assays performed on C. difficile isolates. Demographic, clinical and laboratory data were abstracted. Categorical and continuous variables were compared between the 2 groups using Fisher Exact test and the Mann-Whitney test, respectively. RESULTS:Thirty-five of 188 (19%) stool samples from symptomatic patients and 18 of 74 (24%) samples from asymptomatic patients were positive by PCR (P=0.31). Among PCR-positive patients, symptomatic patients had a significantly higher proportion of subjects who received antimicrobials in the preceding 30 days (P=0.04) and a greater number of preceding antimicrobial days than did asymptomatic patients (P=0.02) but were comparable with respect to the other variables analyzed. CONCLUSIONS:C. difficile PCR assays are frequently positive in hospitalized children both with and without diarrhea. As we observed a high level of toxigenic C. difficile colonization in children, our findings suggest that a positive C. difficile PCR result in a child with diarrhea should be interpreted with caution.
PMID: 25247582
ISSN: 1532-0987
CID: 4347192

A restricted subset of var genes mediates adherence of Plasmodium falciparum-infected erythrocytes to brain endothelial cells

Avril, Marion; Tripathi, Abhai K; Brazier, Andrew J; Andisi, Cheryl; Janes, Joel H; Soma, Vijaya L; Sullivan, David J; Bull, Peter C; Stins, Monique F; Smith, Joseph D
Cerebral malaria (CM) is a deadly complication of Plasmodium falciparum infection, but specific interactions involved in cerebral homing of infected erythrocytes (IEs) are poorly understood. In this study, P. falciparum-IEs were characterized for binding to primary human brain microvascular endothelial cells (HBMECs). Before selection, CD36 or ICAM-1-binding parasites exhibited punctate binding to a subpopulation of HBMECs and binding was CD36 dependent. Panning of IEs on HBMECs led to a more dispersed binding phenotype and the selection of three var genes, including two that encode the tandem domain cassette 8 (DC8) and were non-CD36 binders. Multiple domains in the DC8 cassette bound to brain endothelium and the cysteine-rich interdomain region 1 inhibited binding of P. falciparum-IEs by 50%, highlighting a key role for the DC8 cassette in cerebral binding. It is mysterious how deadly binding variants are maintained in the parasite population. Clonal parasite lines expressing the two brain-adherent DC8-var genes did not bind to any of the known microvascular receptors, indicating unique receptors are involved in cerebral binding. They could also adhere to brain, lung, dermis, and heart endothelial cells, suggesting cerebral binding variants may have alternative sequestration sites. Furthermore, young African children with CM or nonsevere control cases had antibodies to HBMEC-selected parasites, indicating they had been exposed to related variants during childhood infections. This analysis shows that specific P. falciparum erythrocyte membrane protein 1 types are linked to cerebral binding and suggests a potential mechanism by which individuals may build up immunity to severe disease, in the absence of CM.
PMID: 22619321
ISSN: 1091-6490
CID: 4347212

The effects of daily chlorhexidine bathing on cutaneous bacterial isolates: a pilot study

Soma, Vijaya L; Qin, Xuan; Zhou, Chuan; Adler, Amanda; Berry, Jessica E; Zerr, Danielle M
Chlorhexidine gluconate (CHG) is a topical antiseptic used in a myriad of clinical settings. Recently, CHG baths have been shown to decrease multidrug-resistant organism acquisition and infections and catheter-associated bloodstream infections. The present study examined the effects of daily bathing with CHG on the recovery and antimicrobial susceptibility of cultivable cutaneous bacteria. The objectives of this study were to (1) explore the effects of clinical CHG bathing on cultivable cutaneous bacteria, (2) study the relationship between CHG minimum inhibitory concentration and antimicrobial susceptibility of coagulase-negative staphylococci, and (3) demonstrate the feasibility of the approach so a more definitive study may be performed. Significant decreases in bacterial colony counts and phenotypic diversity occurred with greater CHG exposure. The findings also suggest an inverse relationship between CHG minimum inhibitory concentration and antimicrobial susceptibility. Larger prospective studies are necessary to fully investigate the clinical impact of CHG usage.
PMCID:3346208
PMID: 22573939
ISSN: 1178-6973
CID: 4347202