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Risk Assessment of therapeutic agents under consideration to treat COVID-19 in Pediatric Patients and Pregnant Women
  • Jeff Barrett
Jeff Barrett
Critical Path Institute
Author Profile

Peer review status:POSTED

30 Jul 2020Submitted to British Journal of Clinical Pharmacology
31 Jul 2020Assigned to Editor
31 Jul 2020Submission Checks Completed

Abstract

Aim. Repurposing strategies to address the COVID-19 pandemic have been accelerated. As both pregnant and pediatric patients are likely to be excluded from most planned investigations, the list of repurposed options and the available data on these drugs and vaccines provides a baseline risk assessment and identifies gaps for targeted investigation. Methods. Clinical trials have been searched and reviewed; twenty-three repurposed drugs and drug combinations and 9 candidate vaccines have been assessed regarding the availability of relevant data in pediatrics and pregnant women and to evaluate expected or unanticipated risk. Results. Thirteen of the repurposed drugs or drug combinations are indicated for use in pediatrics in some age category albeit for indications other than COVID-19; 10 of these are indicated for use in pregnant women. Even in cases where these drugs are indicated in the populations, source data from which safety and or dosing could be extrapolated for use in COVID-19 is sparse. Vaccine trials are ongoing and generally exclude pregnant women; only in a few instances have pediatric subgroups been planned for enrollment. Data from individual case studies and RWD may suggest that subpopulations of both pediatric patients and pregnant women may be more at risk, particularly those in an increased inflammatory state. Conclusion. In conjunction with more prospective collaboration, plans are evolving to ensure that we will be better prepared to address similar situations especially in pediatrics and pregnant women where experience is limited and actual practice relies heavily on leveraging data from other populations and indications.