ACTIV-3, part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership is a master protocol designed to allow for the study of multiple investigational agents compared to placebo in adults hospitalized with COVID-19. This adaptive design allows investigational agents to be added and dropped during the study for efficient testing of new agents against placebo within the same trial infrastructure and maximizes efficiency in identifying a safe and efficacious therapeutic agent for COVID-19. This study is funded by NIAID, NIH in the United States.
In 2020, there was an urgent public health need for rapid development of therapeutic interventions to help combat the COVID-19 pandemic and SCRI was engaged in Aug 2020 to assist TTSH/NCID in grant application, Institutional Review Board (IRB) and Health Sciences Authority (HSA) submission. Main focus was to activate main site (TTSH/NCID) the soonest possible and import study drug in for usage. All of these were achieved within a month and the 1st Singapore patient was successfully enrolled in early Oct 2020. Till date, SCRI has assisted in IRB & HSA submission for 5 protocols and study has progressed to the 4th investigational agent with a total recruitment of 43 subjects.
Every time a study investigational drug is added, SCRI’s Project Management and Research Monitoring team would be fast on the trails of gathering required information for IRB and HSA submission. The team has built an extensive knowledge bank of submission requirements and was able to anticipate the questions that the regulatory have and provide information in an efficient manner to facilitate each protocol approval. Considering how dynamic the pandemic situation is, the team was also able to catch on to new requirements and incorporate the information based on the latest local COVID-19 situations into the submission documents for a shorter review turnaround time.