Risk Assessment of therapeutic agents under consideration to treat COVID-19 in Pediatric Patients and Pregnant Women
Jeffrey S. Barrett, PhD, FCP
Critical Path Institute
1730 East River Road
Tucson, Arizona 85718-5893
jbarrett@c-path.org
Phone: 215-595-6014
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ABSTRACT – 250-word limit (299)
Aim. Repurposing strategies to address the COVID-19 pandemic have been accelerated in the hope that one or more of these options can be available quickly. As both pregnant and pediatric patients are likely to be excluded from the majority of planned investigations, the list of repurposed options in light of the COVID-19 disease progression and the available data on these drugs and vaccines provides a baseline risk assessment and identifies gaps for targeted investigation in these populations should mainstream clinical trials look promising.
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 make a preliminary evaluation of any expected or unanticipated risk.
Results. Thirteen of the repurposed drugs or drug combinations are indicated for use in pediatrics in some age category (2 exclusively in Japan, 1 exclusively in the EU) albeit for indications other than COVID-19; 10 of these are indicated for use in pregnant women (1 exclusively in Japan). 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 in 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 and data sharing, plans are evolving to ensure that we will be better prepared to address similar situations especially in pediatrics and pregnant women where experience is often limited and actual practice relies heavily on leveraging data from other populations and indications.