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Tuesday, May 14, 2024 2:16:52 PM
Notwithstanding the "SR" or "standard risk" title, the trial did enroll a significant number of high risk patients if they had been vaccinated. And even in that subgroup, symptoms were not resolved materially sooner:
EFFICACY
The primary objective of the trial was to compare the efficacy of nirmatrelvir–ritonavir with that of placebo for the treatment of Covid-19, as measured by the difference in time to sustained alleviation of all targeted Covid-19 signs and symptoms through day 28. All efficacy end points were evaluated in the population of participants who took at least one dose of nirmatrelvir–ritonavir or placebo and had at least one postbaseline visit. The targeted symptoms were cough, shortness of breath or difficulty breathing, feeling feverish, chills or shivering, muscle or body aches, diarrhea, nausea, vomiting, headache, sore throat, and stuffy or runny nose. Participants recorded daily symptom severity on a 4-point scale (0, absent; 1, mild; 2, moderate; 3, severe). Sustained alleviation was considered to have occurred on the first of 4 consecutive days during which all symptoms that had been scored as moderate or severe and as mild or absent at baseline were scored as mild or absent and as absent, respectively. ...
EFFICACY
Among the 1288 participants who received at least one dose of nirmatrelvir–ritonavir or placebo and had at least one postbaseline visit, the median time to sustained alleviation of all targeted Covid-19 signs or symptoms through day 28 was 12 days in the nirmatrelvir–ritonavir group and 13 days in the placebo group, a difference that was not significant (P=0.60) (Table 2). Similar results were observed in the high-risk subgroup (i.e., participants who had been vaccinated and had at least one risk factor for severe illness) and in the standard-risk subgroup (i.e., those who had no risk factors for severe illness and had never been vaccinated or had not been vaccinated within the previous 12 months).
The huge Panoramic trial in the UK has finally stopped enrolling and will follow patients till September. https://www.panoramictrial.org/ Presumably results will be reported not too long after that, but who knows, they do seem to be taking their time. That's a randomized trial of Paxlovid v. standard of care in a vaccinated population. If Paxlovid doesn't show a benefit (either in symptom relief or reducing hospitalization/death), will that change anyone's mind about using it?
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