Activ-4D / Novel Experimental Covid Therapies Affecting Host Response (Nectar)
Posted Date: Aug 16, 2021
- Investigator: Kristin Hudock
- Specialties:
- Type of Study: Drug
This Master Protocol describes the general design features of a platform trial evaluating therapies targeting the host response to COVID-19 in hospitalized patients. The Master Protocol provides the background and overarching approach to all trials to be conducted on this platform. This includes a rationale for the choice of primary outcome, inclusion and exclusion criteria, randomization and blinding, interim and final analyses, sample size considerations, safety reporting, and data collection. In addition, the Master Protocol describes general principles for trial operations and oversight. Appendices to the Master Protocol provide agent-specific details, including treatment dose, route and frequency, safety information, and any agent-specific considerations related to inclusion and exclusion criteria and blinding procedures.
Criteria:
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Keywords:
Nectar, Activ 4D
For More Information:
Kristin Hudock
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hudockkn@ucmail.uc.edu