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 However, this data has not yet been peer reviewed and larger studies are still ongoing.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 Caveat: this is preliminary, not peer reviewed data.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 phase II-a of Covid RCT?

Oral Molnupiravir phase II-a of Covid RCT (Randomized Controlled Trial) is a clinical trial conducted by the pharmaceutical company Merck to test the safety and efficacy of their oral antiviral drug, Molnupiravir, in treating patients with COVID-19. This phase of the trial specifically focuses on patients who are experiencing mild to moderate symptoms of the disease.

2. How does Molnupiravir work against COVID-19?

Molnupiravir works by inhibiting the replication of the virus in the body. It is a prodrug, meaning it needs to be metabolized in the body before it becomes active. Once activated, it works by introducing mutations in the viral genome, making it unable to replicate and spread to other cells.

3. What is the purpose of a randomized controlled trial?

A randomized controlled trial is a type of scientific study used to test the safety and efficacy of a new drug or treatment. It involves randomly assigning participants to different groups, with one group receiving the new drug or treatment and the other group receiving a placebo or standard treatment. This allows researchers to compare the outcomes between the two groups and determine the effectiveness of the new drug or treatment.

4. What is the significance of phase II-a in the clinical trial process?

Phase II-a is an important stage in the clinical trial process as it helps to determine the optimal dosage and potential side effects of the drug being tested. This phase also provides valuable information on the drug's effectiveness and safety in a larger sample size, which is necessary before moving on to the next phase of the trial.

5. When will the results of this trial be available?

The results of the Oral Molnupiravir phase II-a of Covid RCT by Merck are expected to be available in the second half of 2021. However, it is important to note that the timeline may be subject to change depending on the progress of the trial and the approval process by regulatory authorities.

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