Table 5.
Table of events
| Study day | ||||||||
|---|---|---|---|---|---|---|---|---|
| Enrollment | 1 | 2 | 3–6 | 7 | 8–27 | 28 | 90 | |
| Eligibility | ||||||||
| Inclusion/exclusion | X | |||||||
| Informed consent | X | |||||||
| Randomization | ||||||||
| Randomization | X | |||||||
| Post-randomization | ||||||||
| Study drug administration | X | Xa | ||||||
| Case report forms | X | X | X | X | X | X | ||
| Bedside data element for SOFA score (vitals, GCS) | X | Xb | ||||||
| Biospecimen sampling | X | Xb | Xb | |||||
| Rectal swab | X | |||||||
| Zubrod performance | X | Xb | Xb | |||||
| SF-12 | X | Xb | Xb | |||||
| SnC measurement | X | Xb | Xb | |||||
| CRR SOFA calculation | X | Xb | ||||||
| Adverse event assessment | X | X | Xb | Xb | Xb | Xb | Xb | |
| Survival and rehospitalization assessment | Xb | Xb | ||||||
aParticipants allocated to single-day Fisetin dosing will receive placebo on day 2 to preserve blinding
bPerformed at home via phone or mobile phlebotomy, as relevant, if already discharged