Posts Tagged 'Corona'

COVID-19, Chloroquine, Clinical Trials….

World Corona Virus Cases
https://www.worldometers.info/coronavirus/
FYI: Current as of 2020\03\31 @8:18, at 802,556 cases and 39,012 deaths.

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DISCLAIMER: A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed.
https://en.wikipedia.org/wiki/Prescription_drug

Chloroquine and Hydroxychloroquine ARE “prescription drugs”, and are intended to be taken under the administration and guidance of medical professionals (doctors and pharmacists) in order to maximize safety. (Translation, if you take a prescription drug, you do so at your own risk, and often at extreme risk of receiving a nomination for a Darwin Award.)

My providing information regarding Chloroquine and other treaments is NOT medical advice, it is merely providing a clearing-house of related information in a singular place.  And I fervently advise against the stupidity of taking any prescription medicine, over-the-counter drug, herbal supplement, or vitamin for which you lack understanding of the risks entailed, the dosage requirements, safety precautions, etc. Particularly, when we have the availability of medical practitioners. You’re not living in Mad Max Thunderdome. The COVID-19 pandemic is NOT the end of the world.  Don’t act like it. Use common sense. Understand that for some SARS-CoV-2 (the virus that leads to the COVID-19 disease) is likely to affect no more than a sniffle, while others it can pose a life threatening situation.  Young, healthy, no existing conditions, are at lower risk (& potentially can be silent carriers) while as older, overweight, less healthy individuals are at far greater risk.

Be wiser and prudent, particularly as the holidays (Easter, Passover, etc.) approach.  It may be better to skip having the large yearly traditional family gathering, and miss out on seeing loved ones and family for one year, than to risk not having a loved one in future years, because one individual was an asymptomatic carrier and another family member at high risk. For many, this may be nothing more than a typical cold or flu, but please do not dismiss the danger to others who are at high risk. I have already had to comfort one friend who lost their younger brother (age 35 – https://www.rep-am.com/local/localnews/2020/03/26/wolcott-man-dies-at-35-from-coronavirus/) to the virus.  And while some may point to his weight, blood pressure, etc. as contributing factors to his succumbing to COVID-19 at only 35, recognize that most Americans (myself included) are out-of-shape, overweight, pre-diabetic, etc. Thus the majority of us are at higher risk than we should be for our ages.

 

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c19a

c19b
https://www.mediterranee-infection.com/wp-content/uploads/2020/03/Hydroxychloroquine_final_DOI_IJAA.pdf

https://www.the-scientist.com/news-opinion/is-hype-over-chloroquine-as-a-potential-covid-19-therapy-justified–673

Second study released
https://www.mediterranee-infection.com/wp-content/uploads/2020/03/COVID-IHU-2-1.pdf

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Chloroquine shown to inhibit the original SARS,
https://virologyj.biomedcentral.com/articles/10.1186/1743-422X-2-69

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Pre-print, pending peer review randomized clinical trial
https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v1

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NY Times releases their Coronavirus Case Data for every U.S. County on GitHub.
Article https://www.nytimes.com/article/coronavirus-county-data-us.html
GitHub https://github.com/nytimes/covid-19-data
Besides being interesting from a Corona data standpoint, this is the first time I have seen a major news agency release data thru GitHub.

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FDA, Chloroquine, and COVID-19

CDC Info on Therapeutic options for COVID-19
https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html

The purpose of this document is to provide information on two of the approved drugs (chloroquine and hydroxychloroquine) and one of the investigational agents (remdesivir) currently in use in the United States.

CHLOROQUINE- chloroquine phosphate tablet
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b585ad5-ae86-4403-b83f-8d8363d43da5

Searchable Clinical Trials Site
https://clinicaltrials.gov/

Studies on Chloroquine as an anti-viral for HIV patients.
https://aidsinfo.nih.gov/drugs/569/chloroquine/0/patient

Request for Authorization of Emergency Use of Hydrochloroquine
https://www.fda.gov/media/136534/download

https://www.npr.org/sections/coronavirus-live-updates/2020/03/30/823987540/fda-oks-addition-to-stockpile-of-malaria-drugs-for-covid-19

Fact Sheet …Emergency Use Authorization (EUA) of Hydroxychloroquine for COVID-19
https://www.fda.gov/media/136538/download

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A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19
https://www.sciencedirect.com/science/article/pii/S0883944120303907

  • COVERS: Six articles (one narrative letter, one in-vitro study, one editorial, expert consensus paper, two national guideline documents) and 23 ongoing clinical trials in China. Chloroquine seems to be effective in limiting the replication of SARS-CoV-2 (virus causing COVID-19) in vitro.
  • Chloroquine has been used worldwide for more than 70 years, and it is part of the World Health Organization (WHO) model list of essential medicines.

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COVID-19 Drug Therapy – Potential Options
https://www.elsevier.com/__data/assets/pdf_file/0007/988648/COVID-19-Drug-Therapy_Mar-2020.pdf

  • Chloroquine – In vitro and limited clinical data suggest potential benefit.
  • Hydroxychloroquine – In vitro and limited clinical data suggest potential benefit.
  • Lopinavir; Ritonavir – Role in the treatment of COVID-19 is unclear. Preclinical data suggested potential benefit; however, more recent data has failed to confirm.
  • Remdesivir – Investigational and available only through expanded access and study protocols; several large clinical trials are underway.
  • Azithromycin – Used in some protocols based on theoretical mechanism and limited preliminary data as adjunct therapy.
  • Tocilizumab – Immunomodulating agent used in some protocols based on theoretical mechanism and limited preliminary data as adjunct therapy.
  • COVID-19 convalescent plasma – Investigational use is being studied.

Recently, I’ve seen mention of Melatonin

Which of these have robust clinical trials showing efficacy for treatment of COVID-19? NONE!! And no treatment will, because clinical trials usually take years. Even a single study is likely to take months, and for it to pass muster there must be randomizing, placebo testing, etc. Not something you do in the midst of the worst pandemic crisis in a 100 years!

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CLINICAL TRIALS

The Clinical Trial Model Is Up for Review: Time, Expense, and Quality of Results Are at Issue, As Is the Relationship to Drug Pricing (published in 2014)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4189694/

  • Gilead’s Harvoni, a fixed-dose combination therapy for hepatitis C, was the fastest program in the anti-infectives therapy area with a 20 month clinical duration, and one of the fastest overall. It was also faster than any anti-infectives in the 2014 study.
  • ^ KEY POINT, fastest = 20 months. Do you really want to wait 20 months with COVID-19 running amok?

 

How fast are clinical trial? (Basically many many months to years.)https://www.clinicaltrialsandme.com/resources/how-long-do-clinical-trials-take.html

Future role of AI in Clinical Trials
https://www.cbinsights.com/research/clinical-trials-ai-tech-disruption/

Fastest drug developers and their practices
https://www.centerwatch.com/articles/13284

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Planquenil (brand name) Dosing
https://www.drugs.com/dosage/plaquenil.html

  • Malaria Prophylaxis (preventative) Dose = Adults: 400 mg (310 mg base) once weekly on the same day of each week starting 2 weeks prior to exposure, and continued for 4 weeks after leaving the endemic area. NOTE: This is NOT the dose to treat Malaria, just the dose prescribed to take weekly if entering an area with a high risk of Malaria contraction.
  • Malaria Treatment Dose = Adults: 800 mg (620 mg base) followed by 400 mg (310 mg base) at 6 hours, 24 hours and 48 hours after the initial dose (total 2000 mg hydroxychloroquine sulfate or 1550 mg base). Weight based dosage in adults and pediatric patients: 13 mg/kg (10 mg/kg base), not to exceed 800 mg (620 mg base) followed by 6.5 mg/kg (5 mg/kg base), not to exceed 400 mg (310 mg base), at 6 hours, 24 hours and 48 hours after the initial dose.
  • Lupus Dose = Adults, 200 to 400 mg (155 to 310 mg base) daily, administered as a single daily dose or in two divided doses. Doses above 400 mg a day are not recommended. à The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.
  • Rheumatoid Arthritis (Initial) Dose = Initial adult dosage: 400 mg to 600 mg (310 to 465 mg base) daily, administered as a single daily dose or in two divided doses. In a small percentage of patients, side effects may require temporary reduction of the initial dosage.
  • Rheumatoid Arthritis (Maintenance) Dose = Maintenance adult dosage: When a good response is obtained, the dosage may be reduced by 50 percent and continued at a maintenance level of 200 mg to 400 mg (155 to 310 mg base) daily, administered as a single daily dose or in two divided doses. Do not exceed 600 mg or 6.5 mg/kg (5 mg/kg base) per day, whichever is lower, as the incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.

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Amesh Adalja, MD, of the Johns Hopkins University Center for Health Security, said hydroxychloroquine has been well-studied, and has both antiviral and anti-inflammatory properties.
http://www.cidrap.umn.edu/news-perspective/2020/03/trump-says-fda-fast-track-approve-covid-19-drugs

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German Metrics
https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Situationsberichte/2020-03-20-en.pdf?__blob=publicationFile

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NOTE: The that in this case, the “regular care” entailed the use of other anti-virals, namely lopinavir and ritonavir. Chloroquine is an older med, easily manufactured cheaply.

Malaria Drug Chloroquine No Better Than Regular Coronavirus Care, Study Finds: In the Chinese study, which was conducted by researchers from the department of infection and immunity at the Shanghai Public Health Clinical Center, the 15 patients who didn’t get hydroxychloroquine were treated with conventional care.

This includes bed rest, oxgen inhalation, and the use of anti-viral drugs recommended in China’s treatment guidelines like lopinavir and ritonavir, and antibiotics when necessary.
https://www.bloomberg.com/news/articles/2020-03-25/hydroxychloroquine-no-better-than-regular-covid-19-care-in-study

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“It’s an important tool we have to study and make sure we get good data on good coronavirus patients and what the impact is,” he told CIDRAP News. But he cautioned that there is limited availability of the drug, and many patients with rheumatoid arthritis rely on it. He also worried the sudden interest in the drug could cause supply chain issues.
https://www.the-scientist.com/news-opinion/is-hype-over-chloroquine-as-a-potential-covid-19-therapy-justified–67301

Continues to Facilitate Development of Treatments
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-facilitate-development-treatments

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Wiki – Hydroxychlorquin
https://en.wikipedia.org/wiki/Hydroxychloroquine#cite_note-Cor2020-3

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Can we please stop the foolishness and political-infusion into this pandemic.  All options that show any potential merit for treatment need to be explored and utilized. People are dying.

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December 2022
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