COVID-19 Drugs: University Of Oxford Study Shows That Molnupiravir Does Not Reduce Hospitalization Or Deaths In Vaccinated Adults With COVID-19!
: A new study led by researchers from University of Oxford has found that Molnupiravir that is being promoted by many charlatans and dubious health experts and authorities, does not reduce hospitalization or risk of mortality in vaccinated adults who have contracted COVID-19!
In fact, the overpriced drug that costs more than US$720 for a seven-day course day course has been found to catalyze the formation or new SARS-CoV-2 variants and should not have been approved for use in the first place to treat COVID-19.
A recent study has also confirmed that treatment with Molnupiravir leads to the rapid accrual of hundreds of SARS-CoV-2 mutations in immunocompromised patients.
According to the study team led by researchers from the University of Oxford, the safety, effectiveness, and cost-effectiveness of Molnupiravir, an oral antiviral medication for SARS-CoV-2, has not been established in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19.
The researchers aimed to establish whether the addition of Molnupiravir to usual care reduced hospital admissions and deaths associated with COVID-19 in this population.
The COVID-19 Drugs
study team used the PANORAMIC platform which is a UK-based, national, multi-center, open-label, multigroup, prospective, platform adapted for various randomized controlled trials.
Eligible study participants were aged 50 years or older, or aged 18 years or older with relevant comorbidities and had been unwell with confirmed COVID-19 for 5 days or fewer in the community. Participants were randomly assigned (1:1) to receive 800 mg Molnupiravir twice daily for 5 days plus usual care or usual care only.
A secure, web-based system (Spinnaker) was used for randomization, which was stratified by age (<50 years vs ≥50 years) and vaccination status (yes vs no).
All COVID-19 outcomes were tracked via a self-completed online daily diary for 28 days after randomization.
The primary outcome was all-cause hospitalization or death within 28 days of randomization, which was analyzed using Bayesian models in all eligible participants who were randomly assigned.
The clinical trial was registered with ISRCTN, number 30448031.
For the study, between Dec 8, 2021, and April 27, 2022, 26 411 participants were randomly assigned, 12 821 to Molnupiravir plus usual care, 12 962 to usual care alone, and 628 to other treatment groups (which will be reported separately).
A total of 12 529 partic
ipants from the Molnupiravir plus usual care group, and 12 525 from the usual care group were included in the primary analysis population. The mean age of the population was 56·6 years (SD 12·6), and 24 290 (94%) of 25 708 participants had had at least three doses of a SARS-CoV-2 vaccine.
Hospitalizations or deaths were recorded in 105 (1%) of 12 529 participants in the Molnupiravir plus usual care group versus 98 (1%) of 12 525 in the usual care group (adjusted odds ratio 1·06 [95% Bayesian credible interval 0·81–1·41]; probability of superiority 0·33).
There was no evidence of treatment interaction between subgroups. Serious adverse events were recorded for 50 (0·4%) of 12 774 participants in the Molnupiravir plus usual care group and for 45 (0·3%) of 12 934 in the usual care group. None of these events were judged to be related to Molnupiravir.
The study findings clearly showed that Molnupiravir did not reduce the frequency of COVID-19-associated hospitalizations or death among high-risk vaccinated adults in the community.
The study findings were published in the peer reviewed journal: The Lancet.
The study findings showed that Molnupiravir (taken as an 800mg dose twice daily for five days) does not reduce hospital admissions or deaths in vaccinated adults with COVID-19 infection who are at higher risk of mortality.
Many past sub-standard studies conducted by researchers with a vested interest suggested that Molnupiravir is effective at reducing hospital admissions in patients with mild to moderate COVID-19 and the WHO recommends its use for patients with the highest risk of hospital admission.
Many past studies were also conducted involving large unvaccinated populations and even then, the findings were rather dubious.
The Oxford lead study was carried out in a majority vaccinated population where most COVID-19 infections were the omicron variant and is therefore more applicable to the present situation in the UK.
The drug Molnupiravir was sent directly to the trial participants and was able to be taken orally at home.
The trail findings showed no benefit from Molnupiravir treatment on its primary outcome, which hypothesized that treatment with Molnupiravir for vaccinated, at-risk patients would reduce the likelihood of hospitalization or death.
The study results represent outcomes for patients treated between 8th December 2021 and 27th April 2022, during the peak of the omicron wave in the UK.
There was no benefit observed in hospitalization or death rates between the Molnupiravir group and the control group. In the group treated with Molnupiravir there were 105 cases of death or hospitalization (0.8%), whilst in the control group there were 98 cases of death or hospitalization (0.8%).
However, participants receiving Molnupiravir reported more favorable outcomes for a variety of the secondary outcomes in this study. The median average length of illness in patients who took Molnupiravir was nine days compared to 15 days in the control group. Using statistical modelling that accounted for the range of recovery times across both groups, the authors found that patients taking Molnupiravir recovered an average of 4.2 days quicker compared to patients in the control group.
It was also found that seven patients in the control group did not reach recovery within the 28 days of follow up. A modestly lower number of patients who were treated with Molnupiravir sought further GP care following the trial (20% of Molnupiravir patients compared to 24% of the control group).
The study team said, "As countries move forward with their strategies to manage successive waves of COVID-19 infections, the issue of antibiotic or antiviral resistance must not be forgotten. While it's critical to ensure that patients who are likely to benefit treatment with antiviral treatments, such as Molnuvirapir, receive them; using antivirals to treat patients who are unlikely to benefits carries the risk of further driving antimicrobial resistance, wasting resources, and exposing individuals to unnecessary harm. Therefore, our study contributes to the valuable evidence base on who should not be treated with these precious, newly discovered agents, to empower clinicians to make decisions led by robust evidence when prescribing treatments for COVID-19 infections."
The study team also cautions that the benefits of Molnupiravir use need to be considered in the context of the burden on healthcare services and cost-effectiveness. Further health and economic analyses are ongoing, and participants are still being monitored to determine the effect of COVID-19 treatment with Molnupiravir on longer-term symptoms.
The study team also acknowledges that the trial's open-label design means they were unable to estimate the positive effect of Molnupiravir on symptoms resulting from any placebo effect.
However, this limitation is unlikely to affect the trial's the primary outcome measure of non-elective hospitalization and/or death.
Professor Dr Michael Kidd from the Australian Government Department of Health and Aged Care, Canberra, Australia, who was not involved in the study, commented, “The study team acknowledged that their findings might be "less applicable" in individuals with COVID-19 who are extremely clinically vulnerable. We would go a step further and urge caution in seeking to apply the findings of this study to those at highest risk from COVID-19 complications…Although the PANORAMIC platform was not powered for secondary outcomes, there are important policy implications in the study's secondary endpoints. The trial showed that the addition of Molnupiravir to usual care resulted in faster time to recovery and reduced viral detection and load (in a small virology substudy). The shortened and sustained symptom reduction, together with the effects on viral clearance, could be an important consideration in high-risk settings, such as care homes, in terms of potentially minimizing the spread of infection among high-risk people. Molnupiravir might also provide benefits to health-care systems, especially during community surges, by potentially allowing health workers to return safely to work sooner."
The study team also comprised of scientists and physicians from University College London-UK, University of Liverpool-UK, Cardiff University-UK, University of Nottingham School of Medicine-UK, Vanderbilt School of Medicine-USA, University of Exeter-UK, University of Southampton-UK, University of Glasgow-UK, Queen's University Belfast-UK, North Manchester General Hospital-UK and Berry Consultants, Texas-USA.
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