A Call for Pediatric COVID-19 Clinical Trials.

Abstract

* Abbreviations: COVID-19 — : coronavirus disease 2019 CQ — : chloroquine HCQ — : hydroxychloroquine SARS-CoV-2 — : severe acute respiratory syndrome coronavirus 2 Should children with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection receive antiviral therapy? If so, what should we give, to which children, and for what disease severity? Despite brisk scientific progress elucidating the biology and transmission of SARS-CoV-2, and numerous adult trials testing antiviral therapies, we may pass the formative stages of this pandemic without defining antiviral agents’ appropriate role in pediatric management. We urgently need pediatric clinical trials to establish the efficacy, safety, and pharmacokinetics of the most promising experimental and repurposed coronavirus disease 2019 (COVID-19) therapies proposed to date.1 Researchers of early reports show that pediatric SARS-CoV-2 infection tends to be mild but that some children develop severe disease.2 In these reports, researchers highlight differences between pediatric and adult COVID-19 and argue that risk/benefit calculations of therapies derived from adult trials cannot be readily extrapolated to children. Gaps in our knowledge of pediatric COVID-19 further complicate assessments of risk and benefit. To date, we have a limited understanding of viral kinetics or immune responses in children, what factors predispose some children to severe disease, or how these variables affect responses to therapies. We have equally limited comprehension of how SARS-CoV-2 affects children with primary immunodeficiencies, illnesses requiring immune-compromising therapies, or other complex conditions. Nonetheless, treatment planning for severe pediatric cases, even if they will be few, has spurred children’s hospitals to develop algorithms that include antiviral agents, such as remdesivir, chloroquine (CQ), and … Address correspondence to Jeffrey I. Campbell, MD, Division of Infectious Diseases, Boston Children’s Hospital, 333 Longwood Ave, 6th Floor, Boston, MA 02115. E-mail: jeffrey.campbell{at}childrens.harvard.edu