In the beginning of this article series, Part one focused on two of the four questions asked: 1. What reasons do people give not to take vaccine? 2. What reasons do people give to take vaccine? With series part two, I hope this helps all of us as patients do the best we can navigating this COVID messy maze of medicine. May you gain an objective perspective and resources to do the research on your own.
Again, no one knows better than you what is best for your family. All health conditions must be considered when reaching for multi-layered preventive and treatment protocols. WHAT WORKS FOR ONE PATIENT MAY NOT WORK FOR ANOTHER, even within the same family. We need to also accept no vaccine has ever been 100%, and all meds have some degree of side effect depending on a patient’s overall health history. “Benefit to Risk” always plays a major role in determining what specifically works for each of us. And keep in mind the internet has been a two-edged sword inundating us with information that may or may not be credible. In addition, with rapid changes in recommendations uncertainty only amplifies confusion for us all. So, let’s give questions 3 & 4 a try now.
Question 3: What existing meds have been used and recommended?
Let’s get an overview of question 3 – “What existing meds have been used and recommended? And by which doctors?” One important fact we all need to understand is that US drug manufacturers have a marathon path to go through to get any new or existing medicine approved for COVID or any other disease than what it is designated for. Yet, other countries seem to approve certain drugs faster than the US. And there are so many other variables with each patient . . . their age, gender, health condition, COVID stage of damage, side effects. You name it, the list goes on. So, for any prescription, the drug itself along with FDA restrictions, dosage, and timing are all involved and often complex at every level for a doctor or hospital to decide what to do.
We all wish the FDA, NIH, CDC would move faster on those existing medicines doctors are using, particularly in the early and severe COVID stages. Various meds, dosages, and timing have been used by doctors, such as:
- Hydroxychloroquine (FDA revoked provider EUA use 6/15/21) Studies are a mixed bag on efficacy.
- May 31, 2021 Medrxiv.org “Observational Study on 255 Mechanically Ventilated Covid Patients at the Beginning of the USA Pandemic” (Leon G. Smith, Smith Center for Infectious Diseases; not peer-reviewed; Saint Barnabas Medical Center) 255 COVID19 patients requiring invasive mechanical ventilation (IMV) during first two months of pandemic…By evaluating multiple risk factors and using new methods, increased doses of co-administered HCQ and AZM were associated with >100% increase in survival.
- Ivermectin (not FDA COVID approved)
- Front Line COVID-19 Critical Care Alliance – Ivermectin
- American Journal of Therapeutics: May/June 2021 – “Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19”
- NIH Covid Treatment Guidelines-Ivermectin Mixed reviews
- Monoclonal Antibodies (FDA EUA approval)
- Regeneron or REGN-COV: casirivimab & imdevimab together. According to Karen Brooks Harper (Texas Tribune 8/23/21), “There are now about 140 doctors’ offices, hospitals, clinics and infusion centers in Texas that can not only administer the drug [Regeneron), but order it directly from the company, making it easier to keep it in stock.” Learn more about current status of Regeneron.
- Bamlanivimab & etesevimab together. Healthcare Provider Factsheet. With varying cases studied, risk reduction ranged from 57% to 80%; administered together gives an advantage over bamlanivimab alone against certain SARS-CoV-2 viral variants.
- Tocilizumab. Patients with mild to moderate COVID-19. FDA approved for hospitalized patients. Shown to reduce the risk of death through 28 days of follow-up and decreased amount of time patients remained hospitalized. The risk of patients being placed on ventilators or death also decreased.
- Dexamethasone (corticosteroid)
- According to Harvard Health (9/2021) when hospitalized with severe COVID-19. Patients who required supplemental oxygen or ventilators and who received dexamethasone were less likely to die within 28 days than those who received standard care. No benefit in patients who did not need respiratory support.
- Remdesivir. FDA EUA approved with caution for patients with kidney/renal issues and side effects.
- NIH Remdesivir Guidelines. Remdesivir is not recommended for patients with an eGFR <30 mL/min due to lack of data. Renal function should be monitored. Clinical trials suggest remdesivir may modestly speed up recovery time.
- Inhaled Budesonide (FDA not approved)
- Clinical trial (April 2021)- Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised controlled trial. Reduced the likelihood of needing urgent medical care and reduced time to recovery after early COVID-19)
- Medrxiv.org (April 12, 2021) Inhaled budesonide for COVID-19 in people at higher risk of adverse outcomes in the community: interim analyses from the PRINCIPLE trial. Outcomes-reduced recovery time by a median of 3 days.
Question 4: “What protocols are hospitals using and those not allowed?”
Doctors affiliated with hospitals were sometimes not allowed to use some of these medicines based on what the CDC and FDA were allowing. This takes us to #4 question, “What protocols are hospitals using and those not allowed?”
Back in Nov 2020, the World Health Organization WHO recommended against the use of remdesivir in COVID-19 patients. However, later in 2021, according to the NIH’s Therapeutic Management of Hospitalized Adults With COVID-19 (8/25/21), hospitals were allowing under certain conditions Remdesivir, and others such as Immunomodulators-dexamethasone, baricitnib and tocilizumab.
Hospitals also started using Convalescent Plasma. According to Harvard Medical School, Treatments for COVID-19 (July 12, 2021) hospitals have been using this type of therapy for more than 100 years to treat a variety of illnesses from measles to polio, even SARS. “A small randomized, double-blind, and placebo-controlled trial on patients 65 years and older was published in the New England Journal of Medicine in January 2021.” Those who received convalescent plasma within three days of developing symptoms were 48% less likely to develop severe COVID illness compared to patients who received placebo. However, a meta-analysis of four peer-reviewed and JAMA published randomized clinical trials had less-promising results.
There are other therapeutics being used I have undoubtedly missed here. However, you can research further approved NIH treatments for hospitalized and non-hospitalized at links provided on my website, along with Front Line COVID-19 Critical Care Alliance publications and protocols. You can also track clinical trials with the RAPS link below:
- NIH Therapeutic Management of Hospitalized Adults With COVID-19
- NIH Therapeutic Management of Nonhospitalized Adults With COVID-19
- Front Line COVID-19 Critical Care Alliance – Long Haulers I-RECOVER Management Protocol for Long Haul COVID-19 Syndrome (LHCS) & FLCCC and Allied Publications
- Regulatory Affairs Professionals Society (RAPS) COVID-19 therapeutics tracker (Sept 2021)
According to RAPS, there are currently 83 existing therapeutics in clinical trials. The AMA “COVID-19 therapeutics: What the evidence shows” there has been more than 2,000 clinical trials worldwide but fewer than 5% resulting in actionable information. However, the NIH’s COVID-19 Clinical Trials.gov list shows 6,660 trials that are being conducted along with those completed trials.
Keep in mind, if you are thinking of using a FDA unapproved drug, clinical trials may be going on for many of these drugs. Your doctor may be able to get you on a clinical trial. That way, you may be able to avoid being blocked by a doctor, pharmacy, hospital, or FDA. Go to the NIH website to locate clinical trials (COVID-19 – List Results – ClinicalTrials.gov – shows 6,660).
Just do a net search to find many doctors across the nation and globe utilizing certain meds for their Covid patients at different disease stages, approved and only EUA approved by the FDA or CDC. Timing and disease stage are everything with any therapy used. According to Maha Saber-Ayad, Associate Professor of Pharmacology, College of Medicine, University of Sharjah, UAE, Current Status of Baricitinib as a Repurposed Therapy for COVID-19 (July 2021), with “The emergence of the COVID-19 pandemic . . . it was recognized early that repurposing of available drugs in the market could timely save lives, by skipping the lengthy phases of preclinical and initial safety studies.”
According to John Farley, MD, director of the FDA’s infectious diseases, “there are companies working medication that would improve symptoms faster. The idea is to obtain drugs to help alleviate COVID-19 symptoms in the way that oseltamivir (marketed as Tamiflu) can help treat patients with influenza. The priority, he said, is ‘to keep our highest-risk patients out of the hospital right now, and hopefully we are getting those high-risk patients vaccinated as quickly as possible.’” [source: COVID-19 therapeutics: What the evidence shows by Tanya Albert Henry, AMA Contributing News Writer, 3/29/21].
As you consider your own situation for your family, be honest with yourself about behaviors that increase the risk with COVID and other chronic, life-threatening conditions. I encourage you to dig deeper for the multi-faceted vaccine, drug, and particularly possible nutritional preventive and treatment protocols available to you.