MisterBlues schreef op 4 januari 2021 11:33:
Ik ben benieuwd hoe volatiel de koers zal zijn komende dagen, weken. Het kan niet anders dat de markt wat wankelmoediger is geworden door de EUA afwijzing en door het vele wachten - ook het wachten dan nog komen gaat:
Clarification for what results and outcomes are sought from the current study, as well as, dates we can expect to hear:The current Intravenous ZYESAMI (Aviptadil) study has 196 participants at 12 study sites. It is a Quadruple Masking: Participant, Care Provider, Investigator, Outcomes Assessor.
The Primary Completion Date is slated for January 21, 2021. The Primary Completion Date is the date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.
The Study Completion Date is February 28, 2021. The Study Completion Date is the date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.
Primary Outcome Measures :
Resolution of Respiratory Failure [ Time Frame: Day 0 through day 28 ]
Cumulative distribution of the time to respiratory failure resolution with concurrent survival through day 28Secondary Outcome Measures :
1. Improvement on NIAID Scale (key secondary measure) [ Time Frame: Day 0 through day 28 ] Achievement of score 6-8 on NIAID Ordinal Scale through day 28
2. Survival through day 28 and day 60 [ Time Frame: Day 0 through day 28 ]
Survival probability on Kaplan Meier lifetable through day 28 and day 60
3. Time to ICU discharge [ Time Frame: Day 0 through day 28 ]
Time to discharge from Intensive Care Unit
4. Time on ventilation [ Time Frame: Day 0 through day 28 ]
Time on mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen
5. Time to extubation [ Time Frame: Day 0 through day 28 ]
Time to extubation (for those initially on mechanical ventilation)
6. Time to discharge alive [ Time Frame: Day 0 through day 28 and day 60 ]
Time to discharge alive
7. Multi-organ failure free days [ Time Frame: Day 0 through day 28 ]
Days free of multisystem organ failure
Other Outcome Measures:
1. Respiratory Distress while on mechanical ventilation [ Time Frame: Day 0 through day 28 ] PaO2:FiO2 ratio