Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 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; Yarbrough, April; Aldrich, Margaret; Miyagami, Taiju; Soma, Vijaya L; Grapentine, Steven; Oliveira, Carlos Rocha; Hayes, Molly; Kimberlin, David W.; Jones, Sarah Bruyn; Bio, Laura L.; Morton, Theodore H; Hankins, Jane S.; Maron, Gabriela; Timberlake, Kathryn; Young, Jennifer L.; Orscheln, Rachel C.; Schwenk, Hayden T; Goldman, David L.; Groves, H M; Huskins, W. Charles; Rajapakse, Nipunie; Lamb, Gabriella S; Tribble, Alison C.; Lloyd, Elizabeth C; Hersh, Adam L.; Thorell, Emily A.; Ratner, Adam J.; Chiotos, Kathleen; Nakamura, Mari

doi:10.1093/jpids/piaa175

Cited by 57 publications

(52 citation statements)

References 58 publications

(54 reference statements)

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“…The NIH Guidelines recommends using the combination of Bamlanivimab plus Etesevimab or Casirivimab plus Imdevimab to treat non-hospitalized adults and children (≥12 years and ≥40 kg) with mild to moderate COVID-19 who are at high risk of disease progression, according to High-risk Criteria of the Emergency Use Authorizations (EUA) for Anti-SARS-CoV-2 Monoclonal Antibodies (167,168). At present, conclusive evidences about safety and efficacy of this treatment in children or adolescents are missing (169).…”

Section: Anti-sars-cov-2 Monoclonal Antibodies For the Treatment Of Covid-19mentioning

confidence: 99%

Coronavirus Disease 2019 in Children

et al. 2021

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Since its appearance in Wuhan in mid-December 2019, acute respiratory syndrome coronavirus 2 (SARS-CoV-2) related 19 coronavirus disease (COVID-19) has spread dramatically worldwide. It soon became apparent that the incidence of pediatric COVID-19 was much lower than the adult form. Morbidity in children is characterized by a variable clinical presentation and course. Symptoms are similar to those of other acute respiratory viral infections, the upper airways being more affected than the lower airways. Thus far, over 90% of children who tested positive for the virus presented mild or moderate symptoms and signs. Most children were asymptomatic, and only a few cases were severe, unlike in the adult population. Deaths have been rare and occurred mainly in children with underlying morbidity. Factors as reduced angiotensin-converting enzyme receptor expression, increased activation of the interferon-related innate immune response, and trained immunity have been implicated in the relative resistance to COVID-19 in children, however the underlying pathogenesis and mechanism of action remain to be established. While at the pandemic outbreak, mild respiratory manifestations were the most frequently described symptoms in children, subsequent reports suggested that the clinical course of COVID-19 is more complex than initially thought. Thanks to the experience acquired in adults, the diagnosis of pediatric SARS-CoV-2 infection has improved with time. Data on the treatment of children are sparse, however, several antiviral trials are ongoing. The purpose of this narrative review is to summarize current understanding of pediatric SARS-CoV-2 infection and provide more accurate information for healthcare workers and improve the care of patients.

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Section: Anti-sars-cov-2 Monoclonal Antibodies For the Treatment Of Covid-19mentioning

confidence: 99%

Coronavirus Disease 2019 in Children

et al. 2021

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“…In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for two novel virus-neutralizing monoclonal antibodies (mAbs) for the treatment of mild to moderate COVID-19 in adolescents and adults in specified high-risk groups. However, the safety and efficacy of mAbs for the COVID-19 treatment among children or adolescents remains unclear (70). Most pediatric patients with COVID-19 present a good prognosis and usually recover within 1-2 weeks.…”

Section: Asymptomatic Infection (Silent Infection)mentioning

confidence: 99%

Distinct Characteristics of COVID-19 Infection in Children

Han

Xiao

et al. 2021

Front. Pediatr.

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SARS-CoV-2, a member of the family coronaviridae, has triggered a lethal pandemic termed coronavirus disease 2019 (COVID-19). Pediatric patients, mainly from families with a cluster of infection or a history of exposure to epidemic areas, get infected via direct contacts or air-borne droplets. Children (aged below 18 years) are susceptible to COVID-19, with an average incubation period of about 6.5 days. Most cases present asymptomatic or common cold symptoms such as fever, cough, and myalgia or fatigue, which is milder than adult patients. Besides, most abnormal laboratory and radiologic findings in children with COVID-19 are non-specific. Since no specific chemotherapeutic agents have been approved for children, timely preventive methods could effectively forestall the transmission of SARS-CoV-2. To date, mostly studied cases have been adults with COVID-19, whereas data on pediatrics patients remain poorly defined. We herein conducted a literature review for papers published in PubMed and medRxiv (preprints) between December 2019 and December 2020 that reported on pediatrics patients (aged below 18 years) with a confirmed COVID-19 diagnosis. In this review, we summarized and discussed the pathogenesis, epidemiology, and clinical management of COVID-19 in pediatrics patients to improve our understanding of this new disease in children.

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“…In contrast, testing of bamlanivumab in hospitalized patients showed lack of benefit and a possible unfavorable risk/benefit profile in this population (112). The Pediatric Infectious Diseases Society (PIDS) recommends against routine use of mAb for treatment of COVID‐19 in children or adolescents, but acknowledges that providers may choose to administer mAb on a case‐by‐case basis, if available and proper precautions are in place (113). The EUA for bamlanivumab includes pediatric patients >12 years old and weighing at least 40 kg with positive results of direct SARS–CoV‐2 viral testing within 10 days (ideally within fewer than 10 days).…”

Section: Resultsmentioning

confidence: 99%

American College of Rheumatology Guidance for the Management of Pediatric Rheumatic Disease During the COVID‐19 Pandemic: Version 2

Wahezi

Rubinstein

et al. 2021

Arthritis & Rheumatology

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Objective. To provide clinical guidance to rheumatology providers who treat children with pediatric rheumatic disease (PRD) in the context of the coronavirus disease 2019 (COVID-19) pandemic.Methods. The task force, consisting of 7 pediatric rheumatologists, 2 pediatric infectious disease physicians, 1 adult rheumatologist, and 1 pediatric nurse practitioner, was convened on May 21, 2020. Clinical questions and subsequent guidance statements were drafted based on a review of the queries posed by the patients as well as the families and healthcare providers of children with PRD. An evidence report was generated and disseminated to task force members to assist with 3 rounds of asynchronous, anonymous voting by email using a modified Delphi approach. Voting was completed using a 9-point numeric scoring system with predefined levels of agreement (categorized as disagreement, uncertainty, or agreement, with median scores of 1-3, 4-6, and 7-9, respectively) and consensus (categorized as low, moderate, or high). To be approved as a guidance statement, median vote ratings were required to fall into the highest tertile for agreement, with either moderate or high levels of consensus.Results. To date, 39 guidance statements have been approved by the task force. Those with similar recommendations were combined to form a total of 33 final guidance statements, all of which received median vote ratings within the highest tertile of agreement and were associated with either moderate consensus (n = 5) or high consensus (n = 28).Conclusion. These guidance statements have been generated based on review of the available literature, indicating that children with PRD do not appear to be at increased risk for susceptibility to SARS-CoV-2 infection. This guidance is presented as a "living document," recognizing that the literature on COVID-19 is rapidly evolving, with future updates anticipated.Due to the rapidly expanding information and evolving evidence related to COVID-19, which may lead to modification of some guidance statements over time, it is anticipated that updated versions of this article will be published, with the version number included in the title. Readers should ensure that they are consulting the most current version.Guidance developed and/or endorsed by the American College of Rheumatology (ACR) is intended to inform particular patterns of practice and not to dictate the care of a particular patient. The ACR considers adherence to this guidance to be voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances. Guidance statements are intended to promote beneficial or desirable outcomes but cannot guarantee any specific outcome. Guidance developed or endorsed by the ACR is subject to periodic revision as warranted by the evolution of medical knowledge, technology, and practice.

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Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents

Cited by 57 publications

References 58 publications

Coronavirus Disease 2019 in Children

Coronavirus Disease 2019 in Children

Distinct Characteristics of COVID-19 Infection in Children

American College of Rheumatology Guidance for the Management of Pediatric Rheumatic Disease During the COVID‐19 Pandemic: Version 2

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