4 ms·
Phase 3 trial was stopped on a positive interim analysis by DSMB and in consultation with FDA Interim analysis was performed on approximately half of the total
by lsternlicht 5y ago
Phase 3 trial was stopped on a positive interim analysis by DSMB and in consultation with FDA
Interim analysis was performed on approximately half of the total enrolled patients (775 of the 1550).
Trial included many delta and other variant patients
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Efficacy
• ~50% reduction in hospitalization (14.1% PBO vs 7.3% drug)
• 100% reduction in deaths (8 PBO vs 0 drug)
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Safety
• fewer adverse reactions in the drug arm vs PBO (40% PBO vs 35% drug)
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[Merck Ridgeback press release] https://www.businesswire.com/news/home/20211001005189/en/Merck-and-Ridgeback’s-Investigational-Oral-Antiviral-Molnupiravir-Reduced-the-Risk-of-Hospitalization-or-Death-by-Approximately-50-Percent-Compared-to-Placebo-for-Patients-with-Mild-or-Moderate-COVID-19-in-Positive-Interim-Analysis-of-Phase-3-Study https://www.businesswire.com/news/home/20211001005189/en/Mer...
[clinicaltrials.gov] https://clinicaltrials.gov/ct2/show/NCT04575597?term=molnupiravir https://clinicaltrials.gov/ct2/show/NCT04575597?term=molnupi...
- divbzero 5y agoLooks like the clinical trial was for age 18 and above so an EUA probably would not allow use in children.
- dham 5y agoI mean I think that's ok at this point. Kids are at greater risk of a lot of other things before Covid. We're going to have to figure out how to get our kids to become nose breathers again and fix their enlarged adenoids.
- rory 5y agoIs 40% adverse reaction to a placebo typical? Really makes me wonder how many "side effects" are in our heads..
- programmarchy 5y agoCouldn’t the adverse events in the placebo arm actually be caused by Covid?
- deleted 5y ago[deleted]
- nradov 5y agoProbably. There was no uninfected control group.
- rsynnott 5y agoGiven that this is a drug that's only given to people who _have covid_, I'd say it's incredibly difficult to disambiguate from covid symptoms.
- ashtonkem 5y agoCovid and at least one comorbidity. 14% of the control group died; it’s no surprise that 40% had some sort of bad reaction, since presumably they were in pretty bad shape overall.
- Pyramus 5y agoCame here to say that it's not necessarily in our head - you can knowingly get a placebo and still react to it. As far as I know it's a combination of head, genetics and other unknown factors. In my opinion an underappreciated and understudied field.
- Confiks 5y agoKeep in mind that any negative effects, even those unlikely to be caused by the medication, need to be reported as adverse effects. It allows for making a clean comparison between the placebo, and also makes it possible to retroactively relate effects that have been overlooked previously. For example, you want 'patient was hit by a car' as possible side effect, because the medication could make people drowsy.
- PaulDavisThe1st 5y agoPlease read the excellent popular science book "Cure: A Journey into the Science of Mind Over Body" by author/journalist Jo Marchant. It gives an excellent overview of all things placebo related. ps. the answer to your question seems to be "quite a lot".
- linuxftw 5y agoThat depends. In the case of vaccines, the placebo is often all the ingredients of a vaccines minus the biological component, or in other cases, an already approved vaccine is used as the placebo. So, it's probably a poorly controlled study, or garbage results, or both.
- deleted 5y ago[deleted]