Oral molnupiravir phase II-a of Covid RCT by Merck

  • Thread starter Thread starter jim mcnamara
  • Start date Start date
  • Tags Tags
    Covid Phase
Click For Summary
SUMMARY

The Phase II-a clinical trial of molnupiravir, conducted by Merck, has shown preliminary results indicating its potential efficacy in treating COVID-19. The study involved 202 non-hospitalized adults with confirmed SARS-CoV-2 infection, focusing on the reduction of time to viral negativity through RT-PCR analysis of nasopharyngeal swabs. Of the 182 participants with evaluable samples, 42% exhibited detectable virus levels at baseline. Further Phase II and Phase II/III studies are currently in progress to evaluate the drug's effectiveness.

PREREQUISITES
  • Understanding of clinical trial phases, specifically Phase II-a studies.
  • Knowledge of reverse transcriptase polymerase chain reaction (RT-PCR) methodology.
  • Familiarity with SARS-CoV-2 infection and its clinical implications.
  • Awareness of antiviral drug development processes.
NEXT STEPS
  • Research the design and outcomes of Phase II clinical trials in infectious diseases.
  • Study the mechanisms of action and efficacy of molnupiravir as an antiviral agent.
  • Explore the implications of RT-PCR in viral load assessment and treatment monitoring.
  • Investigate ongoing Phase II and Phase II/III studies related to COVID-19 treatments.
USEFUL FOR

Healthcare professionals, clinical researchers, and pharmaceutical developers interested in antiviral therapies and COVID-19 treatment advancements.

jim mcnamara
Mentor
Messages
4,789
Reaction score
3,852
TL;DR
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 Caveat: this is preliminary, not peer reviewed data.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.
 
Biology news on Phys.org

Similar threads

COVID SARS-CoV-2 Mutations: B.1.1.7, B.1.351 & D614G Research
  • · Replies 93 ·
4
Replies
93
Views
18K