COVID-19 Resources for CHRI Investigators

                                   PRO-COVID-logo

The Child Health Research Institute and Pediatric Research Office teams are dedicated to keeping our investigators and study teams updated regarding the evolving COVID-19 situation. We appreciate your patience as we navigate frequent updates and policy changes from UNMC, CHMC, and the FDA. We have provided answers to Frequently Asked Questions below; however, if there is something not covered here please email the PRO team at PedsResearch@unmc.edu for further assistance.

Frequently Asked Questions:

1. What does the recent FDA Emergency Use Authorization (EUA) mean for COVID-positive pediatric patients at this time?

Providers from the Infectious Disease and Critical Care teams are working in collaboration with the PRO and pharmacy to maintain up-to-date information on our current remdesivir supply, and to prioritize its use based on multiple factors. However, the recent FDA Emergency Use Authorization only applies to the limited donated stock of remdesivir from Gilead. At this time, the PRO team is maintaining its current call schedule in order to provide our patients and providers with continuous coverage in the event that we need to obtain remdesivir through the compassionate use program. 

2. Will there be an opportunity to participate in a remdesivir pediatric clinical trial?

The Pediatric Research Office is currently preparing to participate in a pediatric remdesivir trial with Gilead Sciences. Please refer to Gilead Science's recent Statement on Phase 2/3 Clinical Trial of Remdesivir in Pediatric Patients Hospitalized With COVID-19 for more information about the study.

3. I think I may have a patient who may benefit from receiving remdesivir. What do I do next?

Currently, the Departments of Pediatric Infectious Disease, Critical Care, and Hospital Medicine are working closely to assess and prioritize patients who may benefit from receiving remdesivir. Please reach out to your colleagues to discuss your patient, since there are different requirements for prescribing remdesivir under the EUA versus the compassionate use route. 

If you have any questions, please email us at PedsResearch@unmc.edu.

3. I have an idea for a COVID-19 study, how should I proceed? 

All pediatric investigators are required to submit their projects through the PRO Intake Process. In addition, all research involving coronavirus or subjects with COVID-19 must be reviewed and approved by the COVID Research Pre-Review Panel, prior to review by the IRB. Please complete this form before submission to the IRB.

4. What is the plan for research reopening? 

Please refer to the IRB's COVID-19 page for the most up-to-date information regarding reopening research.

 

General Information and IRB Policies

General Emergency Use Information and IRB Policies

General Compassionate Use Information and IRB Policies

 

Remdesivir Emergency Use Authorization (EUA) Fact Sheets

Remdesivir EUA Fact Sheet for Patients, Parents, and Caregivers

Remdesivir EUA Fact Sheet for Healthcare Providers