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Open Sweden: imPROving Quality of LIFe In the Long COVID Patient (PROLIFIC) 2023 Brodin et al

Discussion in 'Recruitment into current ME/CFS research studies' started by mango, Jun 4, 2023.

  1. mango

    mango Senior Member (Voting Rights)

    imPROving Quality of LIFe In the Long COVID Patient (PROLIFIC)

    Petter Brodin
    Karolinska Institutet, Sweden

    "Brief Summary:
    The purpose of this study is to investigate the efficacy of orally administered nirmatrelvir/ritonavir compared with placebo/ritonavir to improve quality of life in non-hospitalized adult participants suffering from post-acute COVID-19 syndrome."

    "Detailed Description:
    At present there is no curative treatment for post-acute COVID-19 syndrome (PACS). Treatment is focused on symptom management and individualized rehabilitation. There is data indicating SARS-CoV-2 viral persistence and chronic immune system activation in PACS.

    We are proposing an interventional, randomized and placebo-controlled clinical intervention trial of nirmatrelvir/ritonavir (300/100 mg) or placebo/ritonavir (100mg), twice daily for 15 days, in patients suffering from severe PACS.

    Patients meeting the WHO definition of severe PACS will be identified from a database of 988 patients cared for by the Karolinska University Hospital Post-COVID clinics since May 2020, and in whom extensive clinical and laboratory examinations have been performed. A total of 400 patients will be enrolled in this study and these will be randomized in a 2:1 ratio to receive either nirmatrelvir/ritonavir or placebo/ritonavir.

    The study will include deep exploratory systems-level analyses of the immune system in PACS patients, including changes induced by nirmatrelvir/ritonavir (Paxlovid®) treatment. The purpose of this study is to evaluate the efficacy of nirmatrelvir/ritonavir for its potential ability to provide sustained improvement in quality of life, in non-hospitalized patients with post-COVID, a patient group with high unmet medical needs.

    Hypothesis: Nirmatrelvir/ritonavir (Paxlovid®) improves health-related quality of life measured using the EQ-5D-5L VAS scale, as compared to placebo/ritonavir, in objective and pre-defined clinical phenotypes: postural orthostatic tachycardia syndrome (POTS), microvascular dysfunction, inappropriate sinus tachycardia, persistent fever, post exertional malaise (PEM), fatigue, brain fog, dyspnea, dysfunctional breathing patterns or inflammatory phenotypes (increased plasma D-dimer, CRP, ESR and ferritin)."
    shak8, Sean, Hutan and 3 others like this.
  2. RedFox

    RedFox Senior Member (Voting Rights)

    I literally started wincing when I saw that acronym, because the BPSers love stupid acronyms. We should quit using them altogether.

    Aside from that, this study is promising to provide correct results due to its large size.
    bobbler, Hutan, alktipping and 4 others like this.
  3. Hutan

    Hutan Moderator Staff Member

    Aotearoa New Zealand
    I'm very happy to see an anti-viral trial. But...

    About ritonavir:
    Side effects:
    Therefore, the trial design seems odd. For one treatment you have something that might potentially be useful, and for the control you have something that probably won't be useful but has a significant risk of side effects (including vague 'malaise' and other symptoms that can be confused with the Long Covid symptoms). If things work as expected, that's going to exaggerate the benefits of Paxlovid. I would have thought, for an initial study, that there should be a control with placebo/placebo as well, or instead of, the placebo/ritonavir.
    Trish, shak8, SNT Gatchaman and 4 others like this.

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