ABSTRACT
This white paper summarizes the key outcomes, topics, and recommendations from the Canada-India Healthcare Summit 2021 Conference, Biotechnology Session, held on May 20-21, 2021. In particular, the authors have focused their attention on topics ranging from research and development into the etiology and treatment of COVID-19 to novel approaches, such as ultraviolet-C disinfection and cell and gene therapy. The paper also deals with important topics around the effects of food distribution and nutrition on COVID-19 and vice versa, as well as key considerations around research and development, innovation, policy, grants, and incentives, and finally, summarizes the ways in which Canada and India, being close allies, have already begun to partner to fight the pandemic (as well as future strategies to continue this excellent progress). We also include key points raised during the summit and summarize them as part of this white paper.
ABSTRACT
Background : Adeno-associated virus (AAV)-mediated gene therapy is being investigated as a treatment for people with hemophilia A (PwHA). Commonly studied AAV serotypes include AAV5, AAV6, and AAV8. Pre-existing immunity against these AAVs restricts patient eligibility yet, published data on AAV seroprevalence and seroconversion rate in PwHA are limited. Aims : To describe design and recruitment methods used for the SAVVY study. This study is designed to characterize AAV antibody prevalence and titers, evaluate changes in antibody titer over time, and examine factors that may influence antibody positivity, titer, and seroconversion. Study design and recruitment methods seek to minimize the need for in-person study interactions during the COVID-19 pandemic. Methods : SAVVY is a patient-centered, decentralized, prospective, observational study involving blood draws at 2 time points. The target sample size of 1,000 PwHA represents approximately 5% of PwHA in the US. SAVVY employs a user-friendly mobile application, provides remote recruitment through e-consent, and uses a network of 1,800+ laboratories throughout the US for biospecimen sample collection. This approach minimizes patient travel, reduces potential exposure to COVID-19, and removes burden from HTC staff to perform study assessments. Recruitment has leveraged various forms of virtual outreach to physicians, HTC staff, and patient advocacy groups;direct-to-patients are being used to create awareness of the study and its scientific aims. See Table 1. Results : First patient enrollment occurred within four months of final protocol;41 patients were enrolled within 2 weeks of activation. At the time of abstract submission, 105 patients had consented to participate. Conclusions : The COVID-19 pandemic disrupted the progress of clinical studies necessary for the advancement of treatments. Adaptability to existing conditions is critical. Careful study design and multi-modal engagement with the hemophilia community can facilitate the conduct of studies, minimize risks associated with COVID-19, and may enhance patient experience and clinical trial recruitment.
ABSTRACT
BACKGROUND: The shortage of single-use N95 respirator masks (NRMs) during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has prompted consideration of NRM recycling to extend limited stocks by healthcare providers and facilities. AIM: To assess potential reuse via autoclaving of NRMs worn daily in a major urban Canadian hospital. METHODS: NRM reusability was assessed following collection from volunteer staff after 2-8 h use, sterilization by autoclaving and PortaCount fit testing. A workflow was developed for reprocessing hundreds of NRMs daily. FINDINGS: Used NRMs passed fit testing after autoclaving once, with 86% passing a second reuse/autoclave cycle. A separate cohort of used masks pre-warmed before autoclaving passed fit testing. To recycle 200-1000 NRMs daily, procedures for collection, sterilization and re-distribution were developed to minimize particle aerosolization risk during NRM handling, to reject NRM showing obvious wear, and to promote adoption by staff. NRM recovery ranged from 49% to 80% across 12 collection cycles. CONCLUSION: Reuse of NRMs is feasible in major hospitals and other healthcare facilities. In sharp contrast to studies of unused NRMs passing fit testing after 10 autoclave cycles, we show that daily wear substantially reduces NRM fit, limiting reuse to a single cycle, but still increasing NRM stocks by â¼66%. Such reuse requires development of a comprehensive plan that includes communication across staffing levels, from front-line workers to hospital administration, to increase the collection, acceptance of and adherence to sterilization processes for NRM recovery.