# BPCA-PTN COVID-19 STUDIES

> **NIH NIH N01** · DUKE UNIVERSITY · 2022 · $999,956

## Abstract

For the last 25 years the scientific community, including academia, the National Institutes of 
Health (NIH), the Food and Drug Administration (FDA) and the pharmaceutical industry have worked to 
improve the knowledge of medications used in children. The responsibility for the implementation 
and oversight for improving drug development has been delegated primarily to the FDA (for on-patent 
drugs) and to the NIH (for off-patent drugs). The Pediatric Trials Network (PTN) has been 
established and funded under the Best Pharmaceuticals for Children Act (BPCA) Clinical Program 
implemented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development 
(NICHD).

Many PTN studies historically capitalize on standard of care (SOC) procedures, such as data and 
biological-sample collection from infants and children already receiving drugs of interest (DOIs), 
and have produced meaningful pharmacokinetic (PK) data resulting in improved dosing recommendations 
in infants and children. These studies do not prescribe or administer drugs to children, but rather 
collected samples from children who were already receiving drugs per SOC as prescribed by their 
treating provider. In addition, preliminary data obtained through opportunistic studies have served 
to design phase 1 through 3 trials in children as well as support applications for extramural 
research.

The coronavirus disease 2019 (COVID-19) pandemic is caused by the novel severe acute respiratory 
syndrome coronavirus 2 (SARS-CoV-2). The infection may range from the patient having no symptoms to 
causing a wide range of symptoms, such as mild cold like symptom to life-threatening pneumonias, 
sepsis, and multi-organ system failure. COVID-19 first emerged in December 2019 when a cluster of 
patients in Wuhan, China developed severe pneumonias of unknown cause. [Wiersinga et al, JAMA 
doi:10.1001/jama2020.12839]. As of August 11, 2020, SARS-CoV-2 has affected more than 200 
countries, resulting in 20,124,437 million identified cases with over 737K confirmed deaths 
[https://www.cdc.gov/coronavirus/2019-ncov]. In April 2020 at the peak of the COVID-19 outbreak, 
there was recognized a new onset of hyperinflammatory symptoms in children who either had active 
disease or in children who had been previously exposed to COVID-19 with or without symptoms. This 
syndrome was named multisystem inflammatory syndrome in children (MIS-C) by the CDC in May 2020. As 
of July 29, 2020, 570 patients have met the criteria for MIS-C in the US 
[https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e2.htm]. As the pandemic continues to spread 
throughout the US and the world, the scientific community anticipates that the number of children 
infected and affected will continue to rise. There must be an organized concerted collaborative 
effort between public health, patient care, and research in order for the appropriate prevention, 
identification and treatment of children impacted by COVID-19.

Since CO...

## Key facts

- **NIH application ID:** 10710641
- **Project number:** 275201800003I-P00001-759402000001-1
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** KANECIA ZIMMERMAN, MD
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $999,956
- **Award type:** —
- **Project period:** 2020-09-21 → 2024-09-20

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10710641

## Citation

> US National Institutes of Health, RePORTER application 10710641, BPCA-PTN COVID-19 STUDIES (275201800003I-P00001-759402000001-1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10710641. Licensed CC0.

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