Tico trial1/15/2023 ![]() The exact number will vary according to the speed of enrollment and the timing of DSMB meetings. This will continue until approximately 300 participants are enrolled and followed for 5 days. For the study of each agent, at the outset of the trial, only participants in disease severity stratum 1 will be enrolled. For investigational drugs with minimal pre-existing safety knowledge, the pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. There are 2 disease severity strata: Participants without organ failure (severity stratum 1) and participants with organ failure (severity stratum 2).Īn independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy outcomes. Randomization will be stratified by study site pharmacy and disease severity. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo. This allows for efficient testing of new drugs against placebo and standard of care (SOC) treatment within the same study. The protocol is for a randomized, blinded, controlled platform study that allows investigational drugs to be added and dropped during the course of the study. This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression. Why Should I Register and Submit Results?. ![]()
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