PA-675 Navigating the COVID-19 pandemic for participant recruitment and follow-up: experiences from the PediCAP clinical trial consortium

Résumé fourni par la source

Background COVID-19, first reported in Wuhan, China in December 2019, was declared a pandemic in March 2020, causing restrictions of movement of people and goods worldwide. This affected every aspect of life, including the conduct of clinical trials. We highlight the challenges faced by the PediCAP consortium and how we navigated them. Methods The PediCAP consortium is composed of 14 partners (https://projectpedicap.org/the-consortium/) in Africa and Europe. The EDCTP-funded clinical trial (ISRCTN63115131) is enrolling children aged 2months to 6years with pneumonia in Mozambique, Uganda, South Africa, Zambia and Zimbabwe. Participant recruitment started in December 2020, during the COVID-19 pandemic; and by end of April 2023, 987 of the targeted 1100 participants (89.7%) had been enrolled. The challenges faced by the clinical sites, and measures taken to mitigate them, were obtained from minutes of monthly teleconferences and interviews with site staff, and summarized in themes. Results The following were reported as challenges and their mitigating measures: Delays in obtaining ethical and regulatory approvals: Ethical and regulatory bodies adopted paperless submissions, virtual review meetings, and used online tools to interact with applicants. Slow recruitment of participants resulting from reduction in numbers of patients attending hospitals, due to fear of contracting COVID-19, and lockdowns restricting movement. This was solved by adding a partner and satellite sites. Additionally, a no-cost extension of the project was made to allow for extension of the recruitment period. Site initiation, protocol training, procurement of trial drugs, and clinical trial monitoring were delayed/problematic. The sponsor adopted virtual platforms and local monitors to mitigate this. A need to protect site staff and participants from contracting COVID-19. Country specific COVID-19 risk management plans were developed and implemented. Conclusion COVID-19 impeded smooth progress of PediCAP trial activities. However, a joint and collaborative effort was key in navigating the challenges.

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