September 15, 2020
Updated: The Effects of COVID-19 on IAVI Clinical Programs
Updated September 15, 2020
IAVI remains committed to ensuring the safety of volunteers and staff in our clinical trials. We have worked closely with our staff and partners to follow guidance issued by public health authorities and government officials in this rapidly changing environment.
Accordingly, IAVI-sponsored clinical trials that had been placed on hold due to the COVID-19 pandemic have re-initiated screening and enrollment activities at most clinical investigative sites.The studies have re-opened in compliance with local and institutional COVID-19 infection control requirements.
Most trials are currently continuing volunteer follow up per trial protocol, with infection containment restrictions being practiced at the local trial sites. For some trials, trial staff are contacting volunteers by other methods such as telephone follow up.
Additionally, the trials are operating in agreement with the FDA guideline “Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency.” Following the FDA guidance in conjunction with the local and institutional requirements will help maintain the safety of all participants, both volunteers and site staff, during the study.
We continue to assess the situation with the aim of ensuring the safety of our volunteers, staff, and partners.