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  1. [verwijderd] 21 februari 2021 17:17
    Estimated Primary Completion Date : August 15, 2021
    Estimated Study Completion Date : September 1, 2021

    Op yahoo : Update in clinicaltrials for inhaled!

    Wat ik denk te lezen is dat er nieuwe studies opgestart zijn, wat ik dan weer als positief beschouw..

    Geduld is een mooie zaak , en alle dagen een % of twee erbij ;-)
  2. forum rang 10 DeZwarteRidder 21 februari 2021 17:24
    quote:

    Gerardke schreef op 21 februari 2021 17:17:

    Estimated Primary Completion Date : August 15, 2021
    Estimated Study Completion Date : September 1, 2021

    Op yahoo : Update in clinicaltrials for inhaled!

    Wat ik denk te lezen is dat er nieuwe studies opgestart zijn, wat ik dan weer als positief beschouw..
    Geduld is een mooie zaak , en alle dagen een % of twee erbij ;-)
    Als ik jou was dan zou ik de inhaler maar snel vergeten.
  3. [verwijderd] 21 februari 2021 17:27
    Dit komt van reddit :
    Why were BRPA warrants up 20% today?? Its Because results are leaking regarding primary Outcome. Clinical Trials data updated! RLFTF/Relief Therapeutics and BRPA are about to announce final results and they are going to be Statistically Signficant
    DD
    Today, 2/18/21, NEuroRx and Relief updated their clinical trials website to modify the primary outcome for Zyesami.

    The original outcome was: resolution of respiratory failure at 28days

    The new outcome is: cumulative distribution of time to respiratory failure resolution (without relapse over 7 days ( with concurrent survival thru day 28)

    This is VERY important. Most patients improve by day 28 whether they got Zyesami or not. BUT the original outcome didn’t take into account the TEMPORAL relationship between those who improved and those who didn’t.

    i.e If you were on high flow NC and got Zyesami, you got out of the hospital 11 days earlier than those folks who didn’t. However, since the average LOS for those without Zyesami was 24 days….their respiratory failure was improved by the 28 day mark and no significance was seen on the preliminary review.

    HOWEVER, if you look at the TIME IT TAKES to get better….there is a statistical significance.

    ex. Say Zyesami patients got out of the hospital on day 14 and say SOC patients got out on day 26. Respiratory failure HAD to have improved faster in the zyesami group to get them out of the hospital sooner….however, everyone was better by day 28.

    As such, the overall 28 day respiratory failure improvement rate was the same, but HOW FAST the patients improved (the “temporal relationship”) was better in the Zyesami group.

    This is why the primary outcome was updated. This is also likely why the warrants were up 20% today on no news. With the last patient enrolled on 12/24/20, 60 days is 2/22/21. That means all but 5 patient shave 60 day data known now and there has been a rolling review of results. Insiders know the results are statistically significant.

    I predict we will eventually hear that:

    -LOS decrease from Zyesami to SOC was statistically significant

    -Survival at 60 days is statistically significant

    -Readmission rate at 60 days is statistically significant

    -Primary outcome of resolution of respiratory failure will be met based on temporal improvement vs SOC

    Source: clinicaltrials.gov/ct2/show/NCT04311697 Click on the tabular view to see the updated
  4. [verwijderd] 21 februari 2021 17:56
    The original outcome was: resolution of respiratory failure at 28days
    Nee hoor dat was niet zo. November 25, 2020:
    "Resolution of Respiratory Failure Cumulative distribution of the time to respiratory failure resolution with concurrent survival through day 28 [Time Frame: Day 0 through day 28 ] "

    clinicaltrials.gov/ct2/history/NCT043...
  5. TraceyH 22 februari 2021 09:18
    quote:

    storer schreef op 21 februari 2021 20:50:

    [...]

    Bull’shit
    Spannend.
    Ik heb er eigenlijk nooit op gelet, maar neem nu dat eua volgt, blijf je dan ook posten in alle nederigheid?
    Nee dan wordt het ' angstvallig' stil ...daar staat hij om bekend. Niets van ooh nee ik heb het totaal verkeerd oid, nee een ' schreeuwende' stilte. Dat zegt genoeg toch.....
  6. [verwijderd] 22 februari 2021 09:31
    Goedemorgen. Na wat rekenwerk is mijn conclusie dat vandaag dag 60 voor de laatste patiënt afloopt. Ik ga ervan uit dat een dag in het onderzoek een periode van 24 uur is zodat de dagen gelijk worden geteld voor alle deelnemers. Deze week verwacht ik dus zeker nieuws, ik neem aan dat ze niet gaan wachten met hele goede resultaten in de hand. In elk geval is nu toch wel een stijgende trend te zien richting het nieuws, dus alles kritisch volgen deze week, succes met het nemen van de juiste beslissingen.
  7. [verwijderd] 22 februari 2021 09:49
    quote:

    Kleintje66 schreef op 22 februari 2021 09:31:

    Goedemorgen. Na wat rekenwerk is mijn conclusie dat vandaag dag 60 voor de laatste patiënt afloopt. Ik ga ervan uit dat een dag in het onderzoek een periode van 24 uur is zodat de dagen gelijk worden geteld voor alle deelnemers. Deze week verwacht ik dus zeker nieuws, ik neem aan dat ze niet gaan wachten met hele goede resultaten in de hand. In elk geval is nu toch wel een stijgende trend te zien richting het nieuws, dus alles kritisch volgen deze week, succes met het nemen van de juiste beslissingen.
    Denk ik ook.

    De echt juiste beslissing kan je eigenlijk pas nemen na nieuws :).
    Ik wacht gewoon af.
  8. [verwijderd] 22 februari 2021 10:06
    quote:

    storer schreef op 22 februari 2021 09:49:

    [...]

    Denk ik ook.

    De echt juiste beslissing kan je eigenlijk pas nemen na nieuws :).
    Ik wacht gewoon af.
    Als het nieuws slecht is kun je beter beslissen voor het nieuws, ik wacht zeker af maar sluit niet uit dat ik niet wacht tot het nieuws er is.
  9. forum rang 4 MisterBlues 22 februari 2021 10:13
    quote:

    Kleintje66 schreef op 22 februari 2021 09:31:

    Goedemorgen. Na wat rekenwerk is mijn conclusie dat vandaag dag 60 voor de laatste patiënt afloopt. Ik ga ervan uit dat een dag in het onderzoek een periode van 24 uur is zodat de dagen gelijk worden geteld voor alle deelnemers. Deze week verwacht ik dus zeker nieuws, ik neem aan dat ze niet gaan wachten met hele goede resultaten in de hand. In elk geval is nu toch wel een stijgende trend te zien richting het nieuws, dus alles kritisch volgen deze week, succes met het nemen van de juiste beslissingen.
    Hier een beschouwing op de verandering van de PE in: 7 dagen vrij van ademhalingsfalen (RF) i.p.v. sterfte (M).

    Modifying the endpoint language was a mechanism to take what is clearly significant secondary endpoint data and roll it into a successful primary endpoint. For better or worse, the FDA always wants RCTs to meet the primary endpoint.


    Another poster a few days ago explained it best. The results will be looked at on something like an hour by hour basis, counting the hours free of respiratory failure for each pt in each arm the achieves the recovery result. By defining the endpoint as requiring 7 days free of RF they are able to weed out patients that may have achieved recovery for only brief periods and eliminate them from the data set of true recovery. For example, if a patient achieves recovery at 12 days but relapses on day 15, they will not get credit for the 3 days of relapse. Now, if they recover again on day 20 and stay out of RF until day 28 they will get 8 days of credit. Since they are looking at cumulative data, eliminating spurious data points is critical. These patients we can surmise are much more likely, though probably not exclusively, in the control arm. This allows the tx arm to demonstrate, by a valid definition of RF recovery, a very large difference in outcome. And that was the only point I ever tried to make about the 7 day modification. I do think that some folks, not necessarily Tom, look at the 7 d modification as somehow helping to achieve significance in 60 day mortality. There I have to disagree. I am not saying that a reduction in 60 day mortality will not be achieved. In fact I think it probably will be achieved. But, and this may be where Tom disagrees, I am not convinced by what we know so far that any reduction in 60 day mortality will be statistically significant. The reason is twofold:

    -First, we are dealing with a small sample size. In order to achieve significance with any small sample size your must demonstrate a LARGE difference in outcome. The small difference in 28 day mortality was not significant for exactly that reason. If the same percentage difference was achieved with a very large sample it would be significant. That is how drugs that marginally improve outcomes can get approval - by demonstrating a small diff in a large sample.

    -Secondly, I think that difference that we see in favor of aviptadil at 60 days is going to have to come primarily from those patients who were still alive and still in the hospital at 28 days. And that is just not a big number from which to draw a large diff in outcomes. I do not think - and maybe this is where Tom's biggest disagreement lies- that there will be a large number a deaths in the placebo arm patients that were discharged. That just does not seem to be the reality of SOC currently. And Tom may not accept this assertion, but I did have the opportunity to ask this very question of two intensivists just this afternoon and they agree completely that, at least in our hospital, discharged patients are not coming back and dying within a month or two because, thankfully, SOC is vastly better than it was last summer. That said, some of the patients in the RCT would have been enrolled before SOC was as good as it is today. So, I wouldn't rule anything out but it is hard to think it is likely that the secondary endpoint of 60 day mortality will be met with statistical significance. It is most important to remember that we are talking about a SECONDARY endpoint. I am confident that the primary endpoint will be met with significance. I am not clear if the 7 day "modification" was really a change or if it was always the intended description. Either way it is quite clever.
  10. forum rang 4 MisterBlues 22 februari 2021 10:21
    En hier een goede verklaring waarom het zo lang moet duren: RF gaat op en af...

    The fact remains I can think of no other explanation that accounts for our stupendous discharge data from both the ICU and hospitals while at the same time not having statistical significance for resolution of respiratory failure?. It can only be explained by relapse of respiratory failure in the SOC group that was still counted as having resolved their respiratory failure. If anyone can think of another explanation of our data, I’m all ears.
9.105 Posts
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