Protocol Paxlovid for Treatment of Long Covid (STOP-PASC), 2022, Singh et al, Stanford University - recruitment stopped June 2023

Discussion in 'Long Covid research' started by Kalliope, Jun 30, 2023.

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  1. Kalliope

    Kalliope Senior Member (Voting Rights)

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    Medpage Today Stanford Study of Paxlovid for Long COVID Stopped Early

    Quote:
    Two sources familiar with the STOP-PASC study told MedPage Today that trial enrollment had been halted. One was told by a study coordinator that a preliminary review found "inconclusive evidence" for the primary outcome of the study. Another said their first appointment was canceled just a few days before it was supposed to take place, and they were later told that all future enrollment had been halted.
     
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  2. Trish

    Trish Moderator Staff Member

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    From the Protocol:

    Paxlovid for Treatment of Long Covid (STOP-PASC)
    Brief Summary:
    The purpose of this study is to compare whether being treated with Paxlovid (nirmatrelvir plus ritonavir) for 15 days works better than being treated with placebo (plus ritonavir) to reduce severe symptoms of Long Covid (the placebo does not have any active drug).

    Participants will have 5 planned visits to the study clinic over 15 weeks and will take the drug (or placebo) for the first 15 days.

    This study uses the term post-acute sequelae of SARS-CoV-2 (PASC), which is another name for "Long Covid."
    Study Design

    Study Type : Interventional (Clinical Trial)
    Estimated Enrollment : 200 participants
    Allocation: Randomized
    Intervention Model: Parallel Assignment
    Masking: Double (Participant, Investigator)
    Primary Purpose: Treatment
    Official Title: Selective Trial Of Paxlovid for PASC (STOP-PASC): Randomized Double-Blind Placebo-Controlled Pilot Trial of Paxlovid for the Treatment of PASC
    Actual Study Start Date : November 8, 2022
    Estimated Primary Completion Date : October 2023
    Estimated Study Completion Date : November 2023
     
    Last edited: Jul 1, 2023
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  3. RedFox

    RedFox Senior Member (Voting Rights)

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    Was it stopped because it was ineffective?
     
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  4. Trish

    Trish Moderator Staff Member

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  5. Trish

    Trish Moderator Staff Member

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    That's what the Medpage article seems to indicate from the bit Kalliope quoted.
     
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  6. Kalliope

    Kalliope Senior Member (Voting Rights)

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    There is also one taking place in Sweden with 400 participants titled imPROving Quality of Life In the Long COVID Patient (PROLIFIC)
     
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  7. Trish

    Trish Moderator Staff Member

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    The article from medpage is on this archive site:
    https://archive.fo/EWHGn

     
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  8. wingate

    wingate Senior Member (Voting Rights)

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    Does anyone know of any updates regarding the 'interim analysis' of the trial data? The MedPage article above is almost a year old now.

    I'm with you @Trish about the impact to the RECOVER trial. If the study was indeed halted because the drug was found to be ineffective then why is RECOVER trying a similar protocol?
     
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  9. EndME

    EndME Senior Member (Voting Rights)

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    They have held presentations at various conferences for the past year with words along the lines of "results could be out anyday". Yale recently declared that they wanted to announce results this June so both results could be out anyday now, the same applies to the results by Karolinska Institutet, but I'm not holding my breath...
     

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