Farma

Yngling ØH
22.01.2021 kl 20:06 4089

I ACCORD-2 studien blir det gjort en midlertidig analyse 29 dager (+/-) 3 dager etter at siste pasient er dosert. Hele studien pågår i 90 dager (end of study), men det meste av prøver tas på den 29. dagen (pasienter som er utskrevet må tilbake for å ta tester-, eller undersøkelser utføres via telefon).

"For the purposes of this study, the condition of each potential participant in the study will be assessed using a 9-point category ordinal scale:
0. Uninfected, no clinical or virological evidence of infection
1. Ambulatory, no limitation of activities
2. Ambulatory, limitation of activities
3. Hospitalised – mild disease, no oxygen therapy
4. Hospitalised – mild disease, oxygen by mask or nasal prongs
5. Hospitalised – severe disease, noninvasive ventilation or high-flow oxygen
6. Hospitalised – severe disease, intubation and mechanical ventilation
7. Hospitalised – severe disease, ventilation and additional organ support – vasopressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO)
8. Death"

"Overall mortality will be assessed on Days 15, 29, and 60, and, where applicable, time from treatment (candidate agent) start date to death will be calculated.
The duration (days) of oxygen use and oxygen-free days (to Day 29) will be a secondary endpoint.
The duration of mechanical ventilator-free days (to Day 29) will be a secondary endpoint, as will be the incidence and duration (days) of new mechanical ventilation use.
The duration (days) of intensive care unit (ICU) and hospitalisation will also be a secondary endpoint."

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