Minimizing Aerosol Leakage from Facemasks in the COVID-19 Pandemic.

Background: Aerosol therapies with vented facemasks are considered a risk for nosocomial transmission of viruses such as severe acute respiratory syndrome coronavirus 2. The transmission risk can be decreased by minimizing aerosol leakage and filtering the exhaled air. Objective: In this study, we determined which closed facemask designs show the least leakage. Methods: Smoke leakage was quantified during in- and exhalation in a closed system with expiration filter for three infant, six child, and six adult facemasks (three times each mask), using age-appropriate anatomical face models and breathing patterns. To assess leakage, smoke release was recorded and cumulative average pixel intensity (cAPI) was calculated. Results: In the adult group, aircushion edges resulted in less leakage than soft edges (cAPI: 407 ± 250 vs. 774 ± 152) (p = 0.004). The Intersurgical® Economy 5 mask (cAPI: 146 ± 87) also released less smoke than the Intersurgical® Clearlite 5 (cAPI: 748 ± 68) mask with the same size, but different geometry and edge type (p-value <0.05). Moreover, mask size had an effect, as there was a difference between Intersurgical® Economy 4 (cAPI: 708 ± 346) and 5, which have the same geometry but a different size (p-value <0.05). Finally, repositioning masks increased the standard deviations. Mask leakage was not dependent on breathing patterns within the child group. Conclusions: Mask leakage can be minimized by using a closed system with a well-fitting mask that is appropriately positioned. To decrease leakage, and therewith minimize potential viral transmission, selecting a well-fitting mask with an aircushion edge is to be recommended.

Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures.

The SARS-CoV-2 pandemic has disrupted clinical trials worldwide. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) has tracked clinical trial disruption by surveying its 58 trial sites across 17 European countries and collated information on measures to mitigate the impact of the pandemic and ensure trial continuity. Here, we present recommendations on how to reduce the risk of SARS-CoV-2 exposure to patients and trial staff by implementing remote trial visits where possible, using home assessments, video and phone calls, electronic consent, and home delivery of study drugs. We discuss the practicalities of remote source data verification, protocol amendments, changing trial site location, and staff absences and home working. We outline recommendations on how to protect trial outcomes, including home assessments, safety reporting, protocol deviations, and recruitment challenges. Finally, we discuss the importance of continued access to study drugs via extension trials for some patients. This guidance was co-created from the shared knowledge and experience of sites in our network and was re-distributed directly to all ECFS-CTN sites to help mitigate the impact of further waves of the SARS-CoV-2 pandemic. We will also use this guidance to assist companies, academia, and consortia with future protocol design and risk mitigation plans. This guidance can be applied to clinical trials in other diseases and could help sites that are not supported by clinical trial networks.