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CytoDyn Inc CYDY
(Total Views: 591)
Posted On: 03/13/2021 11:37:59 PM
Post# of 154646
Posted By: ohm20
Re: Riztheinvestor #82913
In that trial I'd like to know what they consider a high risk to progression.

Quote:
Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old

inclusion can include very mild. Oxygen saturation ≥94% is at the low end of normal.

Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptom



What scale are they using for progression? It could be having no fever and progressing to fever could trigger it.


Quote:
Primary Outcome Measures :
Proportion of participants who have progression of COVID-19 through Day 29 [ Time Frame: Up to Day 29 ]



These secondary endpoints are the ones I want to know.

Quote:
Proportion of participants who have progression of COVID-19 as defined by hospitalization >24 hrs or death at Day 8, Day 15, or Day 22 [ Time Frame: Up to Day 22 ]

Proportion of participants who progress to develop severe and/or critical respiratory COVID-19 as manifest by requirement for and method of supplemental oxygen at Day 8, Day 15, Day 22, or Day 29 [ Time Frame: Up to Day 29 ]

Severity and duration of participant-reported symptoms of COVID-19 related illness using the FLU-PRO patient-reported outcome instrument [ Time Frame: Up to 12 weeks ]

Severity and duration of participant-reported symptoms of COVID-19 related illness using the 34-item COVID-19 adapted FLU-PRO (Influenza Patient-reported outcome) instrument. Higher scores mean worse outcome.

29-day, 60-day, and 90-day all-cause mortality [ Time Frame: Up to 90 days ]
















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