COVID-19 Clinical Trial Development

By: Ryan Wolfe / March 24, 2020

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Last week, President Trump, announced the COVID-19 treatments and vaccines are on a “fast track” for development.  But what does that mean?  What is a typical timeline for development and what are the steps that needs followed in order to produce a successful vaccination or treatment?

Currently, the National Institute of Health (NIH) is operating a randomized controlled trial consisting of 45 individuals confirmed to have been diagnosed with the COVID-19 virus.  Each participant will be randomly assigned a placebo or the treatment group.  Throughout the length of this trial, each subject will be monitored regularly by recording: oxygen saturation, blood pressure, temperature, and mucus production among others.  This is referred to as the investigational phase of study, also called Phase 1.  This phase will last approximately 6 weeks, and was commenced just a few weeks ago, in Seattle.

If the proposed vaccine passes through Phase 1, it will enter Phase 2.  Phase 2 consists of a much larger sample size and conducted over a much longer period.  Often, this phase of testing can last a few years.  Since the general public is in need on such a large scale, Congress has granted a certain degree of leniency to expedite the trials.  This could be viewed as a double-edge sword.  On one side, yes, the vaccination research can be expedited.  On the other side, there are often very specific and unique scenarios, on an individualized basis that may not have received the proper amount of study and coordination to truly assess the efficacy of the newly proposed vaccine.image__19_

Phase 3 will proceed like phase 1 and 2 of the trials. Phase 3 will continue to increase the sample size and accommodate many varying health backgrounds. This phase is to appeal to the broader public.  This will determine if this will work for the required amount of population, not just the seemingly healthy population without underlying health concerns prior to the COVID-19 infection. After phase 3 has been satisfactorily completed and approved by the FDA, release of the vaccination can now occur.  As you can put together, this will not be a few months to create a vaccination for this novel corona virus, but up to to 2 years, even under the current global circumstances.

In the immediate future, until vaccination is approved, we will continue to sit back and watch the market volatility rise and fall from the comfort of our home and maintain our social distance.  Recently we have seen historical lows on the crude, distillate, and gasoline industry.  Many of us have felt the impact on our retirement plans as well.  Like always, there will be recovery, but when?

 

https://www.niaid.nih.gov/news-events/nih-clinical-trial-remdesivir-treat-covid-19-begins

https://deep6.ai/the-clinical-trial-process-for-a-covid-19-vaccine/

https://www.wibw.com/content/news/Kansas-has-44-cases-of-the-coronavirus-568969191.html

https://opmed.doximity.com/articles/an-updated-list-of-covid-19-clinical-trials?_csrf_attempted=yes


Categories: oil economy, World Oil Market, Seattle, temperature, COVID-19, clinical trial, FDA, vaccine, general population, study, placebo, clinical, vaccination, Phase, development, treatment, coronavirus, National Institute of Health, World Health Organization, saturation, pressure, blood pressure, NIH, WHO, fast track, oxygen


Ryan Wolfe

Written by

Ryan Wolfe

I am a proud Guttman Energy sales representative, who has a thirst of knowledge for the industry. I come from a strict, service based, industry that allows me to put my customer needs first. I look forward to utilizing my passion and past experience to help bolster my client’s operations. I take a personal pride in anything I do.


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