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Ivermectin to treat C19 in phase 3 trials.

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    Posted: January 11 2022 at 6:52pm

The FDA warned Americans to never use medications like Ivermectin that “is intended for animals.”

They called it a horse drug.

Now a clinical trial conducted by MedinCells and surprisingly funded by the Bill and Melinda Gates Foundation confirmed the safety of ivermectin taken daily in oral form.

According to the press release, there were no side effects observed with the three doses of ivermectin tested up to 100 μg/kg in continuous administration over 1 month in healthy volunteers.

This study is only the beginning of their program which is to develop a long-acting injectable Ivermectin formulation for several months to protect people who are not infected with Covid-19 in order to break the virus chain of transmission. (This will be discussed later on)

MedinCell tested ivermectin taken daily in oral form to simulate the continuous release of the active substance by a long-acting injectable. After completion, the study confirms the safety of ivermectin up to a dose of 100 μg / kg / day in continuous administration over 1 month in healthy volunteers. No significant difference was observed between the treated volunteers and the placebo volunteers in the three cohorts studied successively (daily doses of 50 μg / kg, 75 μg / kg and 100 μg / kg respectively).

Ivermectin has long been considered a safe and effective drug to treat some parasitic diseases. Its action on viruses such as SARS, rabies, influenza, HIV, Dengue or the West Nile has been proven in vivo or in vitro in the past, suggesting a potential against Covid-19. On March 29, 2020, researchers from Monash University in Melbourne, Australia published results from a laboratory cell study showing that Ivermectin can kill the coronavirus in less than 48 hours.

Hundreds of millions of human subjects have been treated with ivermectin for curative or prophylactic purposes worldwide over the last 3 decades. The reference list of this report demonstrates that a large body of data is available, which allows for a detailed analysis of ivermectin medical safety. Undoubtedly, uncertainties remain regarding ivermectin pharmacological effects and mechanisms of action, but when removed, this is not anticipated to alter the main conclusions of this report in any significant way as they rely on an extensive and consistent body of medical publications.

Taking into account all the above, the author of the present analysis of the available medical data concludes that the safety profile of ivermectin has so far been excellent in the majority of treated human patients so that ivermectin human toxicity cannot be claimed to be a serious cause for concern.

Studies have been carried out by research institutes for the past few months to assess the effectiveness of treatment using Ivermectin on hospitalized patients with Covid-19. MedinCell published last January data showing that Ivermectin can be formulated with our BEPO^® technology as a long-acting for varying doses and durations of up to several months.

The company is already developing a long-acting injectable Ivermectin formulation for several months to neutralize the malaria vector. The success of this program is conditioned in particular by the results of future in vitro, in vivo and clinical studies. The objective of these studies will be to validate the efficacy and safety of Ivermectin against Covid-19 for prophylactic (preventive) action in humans and to determine the dose required.

There is still no exact date as to when the product will be released but their goal is to release this year.

“Our hypotheses are being confirmed, says Christophe Douat, CEO of MedinCell: the pandemic continues, and vaccination may not be enough to stop it. The body of clinical data and scientific knowledge supporting the efficacy of ivermectin at a therapeutic dose against Covid-19, in particular as a prophylaxis, continues to grow. In this context, our treatment, based on a widely known molecule, which could be stored at room temperature and which aims to offer protection for several months after a simple injection against Covid-19 and its variants, could become a key tool of the anti-Covid arsenal. Our goal is still to have a product ready in 2022.”

Medincell SA is a France-based manufacturer of biological products and pharmaceutical preparations that works on both for-profit and non-profit projects, in collaboration with partners ranging from pharmaceutical corporations to physicians, from biotechnology firms to academics and foundations.

Japanese Conglomerate Investigates Ivermectin

Kowa reports that their ivermectin-based clinical trial is the first company sponsored study in this Asian nation targeting COVID-19. Initiating a Phase 3 clinical trial (the final stage in the clinical trials process) in November, the industry sponsor continues to seek about 1,000 COVID-19 patients with mild symptoms to take the study drug (ivermectin) or control placebo to compare the progress and investigate whether ivermectin can help accelerate recovery. With ambitious plans initially to complete the study by end of 2021, as reported in the Japanese press, and apply for approval in early 2022, TrialSite questioned the feasibility of such an aggressive timeline. Their formal target study end date is now March 2022.

The company’s pipeline validates the ivermectin strategy now in pivotal Phase 3 clinical trials. Their pipeline can be reviewed here

The Clinical Trial

Kowa Company Ltd. disclosed the Phase 3 ivermectin-based study in the U.S. clinical trials registry. A Phase 3 confirmatory study of their ivermectin investigational product called K-237, the multicenter, placebo controlled, randomized, double-blind, parallel-group controlled trial with up to 1,000 patients with mild COVID-19 started late last year and is planned to end March 31, 2022.

The study drug arm includes 0.3-0.4 mg/kg once daily (Ivermectin 3mg) with one key endpoint: monitoring patients from start of study to 168 hours until clinical symptoms approve with a window of effectiveness between day 1 to 14 of study drug administration.

Secondary endpoints for the study include A) time of improvement in clinical symptoms (headache, abdominal pain, nasal) in the day 1–14-time range and B) time to reach a temperature less than 37.5 ˚C without the use of antipyretics (acetaminophen) in the day 1–14-time range of the study.

"Facts don't care about your feelings" I'M A UNVAXXED DEVIL so kiss my rebel ass.
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