Tuesday, May 26, 2020

Theraputics and a human experience



Theraputics and a human experience

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May 26, 2020
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The FDA-approved drug ivermectin which inhibits the replication of SARS-CoV-2 in vitro

https://www.sciencedirect.com/science...

FDA-approved anti-parasitic, therefore has a potential for repurposing

Previously shown to have broad-spectrum anti-viral activity in vitro

It has been demonstrated to limit infection by some RNA viruses such as DENV 1-4

An established safety profile for human use

Recent reviews and meta-analysis indicate that high dose ivermectin has comparable safety as the standard low-dose treatment

An inhibitor of SARS-CoV-2 in vitro.

A single treatment able to effect ~5000-fold reduction in virus at 48 hours in cell culture

Been shown to be effective against the DNA virus pseudorabies virus (PRV) both in vitro and in vivo, (mice)

Ivermectin widely available, due to its inclusion on the WHO model list of essential medicines

Warrants further investigation for possible benefits in humans

Phase III clinical trial in Thailand in 2014–2017, against DENV infection

Single daily oral dose observed to be safe

No change in viremia or clinical benefit was observed


https://clinicaltrials.gov/ct2/show/N...
June 2021

https://www.trialsitenews.com/gates-f...

US Food and drug administration. FAQ: COVID-19 and Ivermectin Intended for Animals

https://www.fda.gov/animal-veterinary...

Q: Should I take ivermectin to prevent or treat COVID-19?
A: No. While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19. You should not take any medicine to treat or prevent COVID-19 unless it has been prescribed to you by your health care provider and acquired from a legitimate source.
A recently released research articleExternal Link Disclaimer described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. These types of laboratory studies are commonly used at an early stage of drug development. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19.
Q: Is there an emergency use authorization for ivermectin in the U.S. to prevent or treat coronavirus or COVID-19?
A: No. FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we can gain valuable knowledge about their safety and effectiveness.

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