COVID-19 Response Among US Hospitals with Emerging Special Pathogen Programs.

In February 2015, the US Department of Health and Human Services developed a tiered hospital network to deliver safe and effective care to patients with Ebola virus disease (EVD) and other special pathogens. The tiered network consisted of regional special pathogen treatment centers, state- or jurisdiction-designated treatment centers, assessment hospitals able to safely isolate a patient until a diagnosis of EVD was confirmed and transfer the patient, and frontline healthcare facilities able to identify and isolate patients with EVD and facilitate transport to higher-tier facilities. The National Emerging Special Pathogens Training and Education Center (NETEC) was established in tandem to support the development of healthcare facility special pathogen management capabilities. In August 2020, 20 hospitals that previously received an onsite readiness consultation by NETEC were surveyed to assess how special pathogen programs were leveraged for COVID-19 response. All surveyed facilities indicated their programs were leveraged for COVID-19 response in at least 1 of the following ways: NETEC-sponsored resources and training, utilization of patient isolation spaces, specially trained staff, and supplies. Personal protective equipment shortages were experienced by 95% of facilities, with 80% of facilities reporting that special pathogens program personal protective equipment was used to support facility response to COVID-19 admissions. More than half of facilities (63%) reported leveraging biocontainment unit staff to provide training and education to frontline staff during initial response to COVID-19. These findings have implications for planning and investments to avoid the panic-then-forget cycle that hinders sustained preparedness for future special pathogens.

Prepared to Act: Lessons Learned by the Special Pathogens Research Network, Based on Collaborations with the NIAID-Led Adaptive COVID-19 Treatment Trial.

The need for well-controlled clinical trials is fundamental to advancing medicine. Care should be taken to maintain high standards in trial design and conduct even during emergency medical events such as an infectious disease outbreak. In 2020, SARS-CoV-2 emerged and rapidly impacted populations around the globe. The need for effective therapeutics was immediately evident, prompting the National Institutes of Health to initiate the Adaptive COVID-19 Treatment Trial. The Special Pathogens Research Network, made up of 10 Regional Emerging Special Pathogens Treatment Centers, was approached to participate in this trial and readily joined the trial on short notice. By trial closure, the Special Pathogens Research Network sites, making up 19% of all study sites, enrolled 26% of the total participants. The initial resources available and experience in running clinical trials at each treatment center varied from minimal experience and few staff to extensive experience and a large staff. Based on experiences during the first phase of this trial, the Special Pathogens Research Network members provided feedback regarding operational lessons learned and recommendations for conducting future studies during a pandemic. Communication, collaboration, information technology, regulatory processes, and access to resources were identified as important topics to address. Key stakeholders including institutions, institutional review boards, and study personnel must maintain routine communication to efficiently and effectively activate when future research needs arise. Regular and standardized training for new personnel will aid in transitions and project continuity, especially in a rapidly evolving environment. Trainings should include local just-in-time training for new staff and sponsor-designed modules to refresh current staff knowledge. We offer recommendations that can be used by institutions and sponsors to determine goals and needs when preparing to set up this type of trial for critical, short-notice needs.