Yet Another Randomized Trial Shows Efficacy Of Ivermectin To Treat COVID-19 But It Will Never Become Mainstream Due To Western Pharmaceutical Giants
: Indian researchers from the All India Institute of Medical Sciences have conducted a a double-blind, randomized, placebo-controlled clinical trial that demonstrated the efficacy of Ivermectin to treat COVID-19 disease. The clinical trial showed that Ivermectin, an anti-parasitic drug, can reduce in-hospital mortality rate COVID-19 patients.
Ivermectin is currently being used with success in many parts of the world to treat COVID-19.This randomized control trial was conducted to test the efficacy of Ivermectin in the treatment of mild and moderate COVID-19.
The trial involved a parallel, double blind, randomized, placebo controlled trial at a tertiary care dedicated COVID-19 hospital in Bihar. Adult patients (> 18 years) admitted with mild to moderate COVID 19 disease (saturation > 90% on room air, respiratory rate < 30 and no features of shock) with no contraindications to ivermectin and willing to participate in the study were enrolled.
Patients in the intervention arm were given ivermectin 12 mg on day 1 and day 2 of admission. Patients in the placebo arm were given identical looking placebo tablets. Rest of the treatment was continued as per the existing protocol and the clinical judgment of the treating teams.
The primary outcome measure was a negative RT-PCR test for SARS-CoV-2 on day 6 of admission. The secondary outcome measures were symptom status on day 6, discharge status on day 10, admission to ICU, need for invasive mechanical ventilation and in-hospital mortality.
A total of 115 patients were enrolled for the study of which 112 were included in the final analysis. Of them, 55 were randomized to the intervention arm while 57 were randomized to the placebo arm. There was no significant difference in the baseline characteristics of the two arms. There was no significant difference in the primary outcome, i.e. negative RT-PCR status on day 6 between the two groups. Similarly, there was no significant difference between the two groups in most of the secondary outcome measures, viz. symptom status on day 6, discharge status on day 10, admission to ICU, and need for invasive mechanical ventilation.
However, while there was no in-hospital mortality in the intervention arm, there were 4 deaths in the placebo arm. As a result, all patients in the intervention arm (n=56) were successfully discharged as compared to 93.1% (n=54/58) in the placebo arm (RR 1.1, 95% CI 1.0 to 1.2, p=0.019). Conclusion: There was no difference in the primary outcome i.e. negative RT-PCR status on day 6 of admission with the use of ivermectin. However, a significantly higher proportion of patients were discharged alive from the hospital when they received ivermectin.
The study results were published on a preprint server and are currently being peer reviewed. https://www.medrxiv.org/content/10.1101/2021.01.05.21249310v1
The highly infectious and deadly SARS-CoV-2 virus, the causative pathogen of COVID-19, has already infected more than 91 million people and claimed more than 1.94 million lives globally.
As a result of the unavailability of specific therapeutics against SARS-CoV-2, the treatment of moderately or severely affected COVID-19 patients is mostly carried out by repurposed antiviral
medicines, these have included hydroxychloroquine, lopinavir, interferon, and remdesivir.
However the WHO Recovery Trials and various other studies have shown that none of these are effective to treat COVID-19.
Also low dose steroids and convalescent plasma have been tried clinically to treat in-hospital patients with severe COVID-19. Most repurposed medicines have failed to significantly improve the COVID-19 outcomes and reduce the mortality rate.
Worse still the usage of some of these protocols have possibly lead to the emergence of antibody resistant ad drug resistant SARS-CoV-2 mutations and strains.
The drug ivermectin is an anti-parasitic drug primarily used to treat onchocerciasis, lymphatic filariasis, strongyloidiasis, cutaneous larva migrans, and scabies. The drug is known to induce paralysis by activating ligand-gated chlorine channels in invertebrates.
Importantly the drug is known to exert antiviral activity against RNA viruses, probably by inhibiting the import of host and viral proteins to the nucleus. Regarding COVID-19 treatment, several observational studies, clinical trials, and in vitro studies have shown that ivermectin has the potential to be used as an antiviral medicine against SARS-CoV-2 infection.
For this clinical trial, the scientists studied the efficacy of ivermectin in treating mild and moderately affected COVID-19 patients.
In all a total of 112 adult COVID-19 patients were enrolled for the trial; of them, 55 were administered with 12 mg of ivermectin on days 1 and 2 of the hospital admission, whereas 57 were administered with a similar-looking placebo medicine. In addition, all patients received the standard of care treatment.
The study team specifically compared the status of viral clearance on day 6 of admission between the ivermectin-treated and placebo-treated groups. In addition, they investigated whether there is any difference in symptom severity, duration of hospital stay, admission to intensive care unit (ICU), requirement for mechanical ventilation, and in-hospital mortality between the two groups.
The study findings reveal that about 23% of patients receiving ivermectin and 31% of patients receiving placebo drug tested negative for SARS-CoV-2 via polymerase chain reaction (PCR) on day 6 of admission. This indicates that ivermectin is not effective in speeding up the viral clearance process. However, the scientists have mentioned that further studies are required to get a comprehensive information on viral clearance, because serial PCR tests have not been conducted in the current study. Moreover, conclusive PCR reports could not be achieved in 32% of patients.
No significant differences in symptomatic status, hospital discharge status, ICU admission, and need for mechanical ventilation have been observed between the ivermectin-treated and placebo-treated groups.
Though ivermectin fails to show any added benefit over the placebo medicine, no in-hospital mortality has been observed in the ivermectin-treated group; whereas, 4 patients in the placebo-treated group have died during their hospital stay. Taken together, these findings indicate that ivermectin has the potential to improve the in-hospital survival rate of patients with mild or moderate form of COVID-19.
The study team commented, “The study findings of this trial should be interpreted with consideration to certain limitations. A conclusive repeat RT-PCR report could not be obtained in 32.1% of the patients. Moreover, as serial RT-PCR tests were not done, the median time to viral clearance in the two groups could not be ascertained. As only mild and moderate cases were included, it cannot be said whether the benefit in survival seen with ivermectin can also be seen in severe cases. Similarly, it cannot be said on the basis of this study whether or not using higher doses of ivermectin or combining it with other drugs like doxycycline would offer any additional benefit. Similar but larger studies may be able to give a more definitive answer, especially in relation to the other secondary outcome measures.”
It should be noted that numerous other observational and randomized clinical trials have already been conducted around the world demonstrating the efficacy of ivermectin to treat COVID-19. https://www.thailandmedical.news/news/yet-another-randomized-trial-shows-ivermectin-effectiveness-to-treat-covid-19,-this-time-by-researchers-from-clinica-universidad-de-navarra-spain
Also a randomized trial in India involving healthcare workers showed that it acted effectively as a prophylaxis against the SARS-CoV-2 coronavirus. https://www.thailandmedical.news/news/covid-19-prophylaxis-aiims-study-of-healthcare-workers-in-india-using-ivermectin-as-a-prophylaxis-shows-reduced-covid-19-infection
Yet another randomized trial showed that it was effective to treat severe COVID-19 patients with results even much more promising that U.S. FDA approved drugs like remdesivir that lacks any efficacy and does not improve mortality rates unlike ivermectin. https://www.thailandmedical.news/news/breaking-randomized-multi-center-clinical-trial-shows-that-ivermectin-is-effective-to-treat-covid-19
The drug ivermectin first gained importance as a potential pharmaceutical candidate to treat COVID-19 after a research team from Monash University showed that it could inhibit the SARS-CoV-2 coronavirus in vitro studies in early April. https://www.thailandmedical.news/news/must-read-covid-19-drug-research-ivermectin-might-emerge-as-one-of-the-most-suitable-drug-candidates-for-covid-19
There are concerted effort by the big Western pharmaceutical companies and even Western governments especially in America and the United Kingdom to ensure that cheaper repurposed generic drugs, herbs and supplements are never promoted to treat COVID-19 as they prefer to advocate new expensive drugs that had no efficacy but are in fact toxic as there are financial gains for all vested parties. Such is the case involving remdesivir and even certain monoclonal antibody therapeutics that are actually leading to the emergence of antibody resistant strains.
The rest of the world should simply avoid recommendations or suggested warnings or protocols from the Western experts and regulatory bodies especially the U.S. FDA which is now one of the most non-credible regulatory agencies in the world. With all their so called ‘experts’ and know how, its laughable to see how countries like America and the United Kingdom are the worst affected in terms of the COVID-19 pandemic with thousands sadly dying each day.
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