Oral molnupiravir phase II-a of Covid RCT by Merck

In summary, preliminary results from a phase II-a study of Molnupiravir in COVID-19 have shown potential for a reduction in time to viral negativity in non-hospitalized adults with confirmed active SARS-CoV-2 infection. However, this data has not yet been peer reviewed and larger studies are still ongoing. If successful, Molnupiravir could potentially fill a gap for an oral anti-viral medication for early COVID-19 treatment.
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jim mcnamara
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TL;DR Summary
Oral molnupiravir showed positive results in clearing virus times Covid patients enrolled in a double blind RCT by Merck
News release
https://www.thepharmaletter.com/art...iia-trial-results-of-molnupiravir-in-covid-19

Molnupiravir has passed part of a phase II-a study. Caveat: this is preliminary, not peer reviewed data.

Study design
This multicenter US Phase IIa study enrolled 202 non-hospitalized adults who had signs or symptoms of COVID-19 within seven days and confirmed active SARS-CoV-2 infection. The primary efficacy objective was reduction in time to viral negativity measured by reverse transcriptase polymerase chain reaction (RT-PCR) analysis of nasopharyngeal swabs. Periodic samples were collected for virologic analysis. Of the 182 participants with an evaluable nasopharyngeal swab, 42% (78/182) showed detectable levels of cultured virus at baseline. Other Phase II and Phase II/III studies are underway.

Earlier paper Feb 24 2021:
https://aac.asm.org/content/early/2021/02/24/AAC.02428-20.abstract

If we assume all goes well then there is potential for filling a much needed oral anti-viral medication for people with early Covid-19.
 
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1. What is oral molnupiravir and how does it work?

Oral molnupiravir is an antiviral drug being developed by Merck for the treatment of Covid-19. It works by inhibiting the replication of the virus, preventing it from spreading and causing further damage to the body.

2. What is the phase II-a trial for oral molnupiravir?

The phase II-a trial is a clinical trial conducted to evaluate the safety and effectiveness of oral molnupiravir in treating Covid-19. It involves testing the drug on a small group of patients to determine the appropriate dosage and potential side effects.

3. What is an RCT and why is it important for this trial?

An RCT (Randomized Controlled Trial) is a type of study where participants are randomly assigned to receive either the treatment being tested or a placebo. It is important for this trial because it helps to ensure that any observed effects of the drug are not due to chance or other factors.

4. What are the expected outcomes of the phase II-a trial for oral molnupiravir?

The expected outcomes of the trial are to determine the safety and efficacy of oral molnupiravir in treating Covid-19. This includes assessing its ability to reduce the severity of symptoms, shorten the duration of illness, and prevent the need for hospitalization.

5. When will the results of the phase II-a trial be available?

The results of the phase II-a trial for oral molnupiravir are expected to be available in the first half of 2021. However, this timeline may vary depending on the progress of the trial and the analysis of the data.

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