Clinical Trials and Research News Weekly Roundup | Doctor Claims Silver Bullet COVID-19 Treatment |S2 E29

Jul 20, 2020 | Digital Media, Video, Weekly Roundup

TSN Weekly roundup

West Texas Doctor Claims of ‘Silver Bullet’ Off-Label Use of Inhaled Steroid as COVID-19 Treatment:

A local West Texas doctor believes he has come up with an approach to effectively treat #COVID19. Dr. Richard Bartlett has practiced medicine in Texas for 28 years, and according to his claims, he advised ex-Governor of #Texas, Rick Perry for several years. Now, Dr. Bartlett does a regular weekly radio update on COVID-19 in West Texas, and recently, he found himself embroiled in controversy when he declared that that the treatment of inhaled steroid (ICS) #Budesonide is a ‘silver bullet’ for treating COVID-19. So let’s take a step back here and make a few points here. First, the doctor knows all too well the politics and regulatory considerations of the U.S. healthcare system and as such, he must know that making claims this soon in his study is bound to stir up controversy within these systems. Second, he is not alone in considering this approach, as world-renowned universities such as England’s Oxford University are also studying this type of regimen. Third, and this is important for those who may want to just dismiss this out of hand, as Dr. Bartlett is part of a movement of community doctors demonstrating practical potential approaches to reducing the severity of the pandemic, any real-world data should be embraced rather than ridiculed, and if it turns out promising, rapidly incorporated into research. And Fourth, that certain societal forces will pounce on one mistake in messaging in an attempt to tarnish an entire real-world approach with promise, which evidences just how politicalized health and medicine has become in the age of COVID-19.

The Italian ‘COVER Trial’ has Regional Hospital & Pharma Research Institute Investigate Ivermectin for Early Stage COVID-19: IRCCS Sacred Heart Don Calabria Hospital is an accredited Italian provider in the Veneto region that accommodates about 30,000 patients per year, includes 968 beds and employs approximately 1,712. The regional provider has come together with Mario Negri Institute for Pharmacological Research, a nonprofit research institute dedicated to clinical and biomedical research, to conduct the ‘COVER trial’, a 102 patient, prospective, multi-center, randomized, double-blind trial to assess efficacy and safety of Ivermectin for the treatment of initial infection with SARS-CoV-2 infection. Led by infectious and tropical disease expert Dr. Zeno Bisoffi, the study nears launch and will be conducted through August with final reports planned for October 2020. The study will span regions of Italy and Spain.

The INO-4800 Vaccine Trial Sponsor (IVI) in Korea Selects CRO LSK Global Pharma Services: A leading clinical research organization (CRO) called LSK Global Pharma Services (PS) has inked a deal with the International Vaccine Institute’s (IVI) clinical trials of Inovio’s INO-4800, a DNA-based COVID-19 vaccine candidate in Korea. In this study, IVI, Seoul National University Hospital, and SNU Bundang Hospital will spearhead the Phase 1 and 2 clinical trials of IVO-4800 in that Asian nation. LSK will serve as CRO overseeing the overall operations: from project management to monitoring, data management, and pharmacovigilance activities.

The Dhaka Trial: Clear-Cut Evidence Favipiravir Effective against COVID-19 with Compelling Results The Bangladesh Society of Medicine (BSM) concluded from a recent study that Favipiravir evidences “clear cut” safety and effectivity against COVID-19. Apparently the “Dhaka Trial,” a randomized and controlled clinical trial conducted in Dhaka revealed similar positive effects of Favipiravir (Avigan) in COVID-19 patients as has been the case in China and Russia. The clinical trial sponsor, BSM, observed that of the patients in the clinical trial 96% were found to have negative test results (RT-PCR) after the Favipiravir treatment. Favipiravir is approved in multiple countries targeting COVID-19, including China, Russia and India. The U.S. Department of Defense spent over $200 million testing it in clinical trials just five years ago for exactly the kind of pandemic now faced. Why don’t Americans hear more about it? HTTPS://WWW.TRIALSITENEWS.COM/THE-DHAKA-TRIAL-CLEAR-CUT-EVIDENCE-FAVIPIRAVIR-EFFECTIVE-AGAINST-COVID-19-WITH-COMPELLING-RESULTS/

1 Comment

  1. Paul E.

    While Dr. Bartlett’s claims are grandiose they aren’t completely without merit. However, he missed a critical insight into the therapeutic benefit of ICS for Covid-19. There are two potential approaches to ICS treatment with Covid-19. First, and most promising, is to use ICS early in the disease progression during the viral replication stage. The main goal here is to inhibit the viral replication to reduce the progression of the disease to a more severe state. This needs to be accomplished with a careful balancing of antiviral activity while minimizing immunosuppression. There is one ICS that has shown to be very promising in both of these aspects. The ICS is called ciclesonide, and while it is in the family of glucocorticoids it’s antiviral activity is unique. In addition, ciclesonide exhibits a more mild suppression of the immune system compared to other ICS medications (i.e. budesonide). These traits make it ideal for treating Covid-19 early during the viral stage (optimally at first sign of symptoms). It’s also available in nasal spray and inhaler on an outpatient basis.

    The glucocorticoid that Dr. Bartlett chose is budesonide. This ICS shows no antiviral activity against SARS-CoV-2 and it significantly inhibits the immune system. This means that budesonide should NOT be used early during the viral stage of Covid-19. However, it still could be very useful for later stage Covid-19 when the virus has been controlled, but the immune system is showing hyperinflammation and dysregulation. This would be a similar approach to the proven benefits of dexamethasone with a more targeted delivery to the lungs.

    Here is an excellent summary of the evidence for inhaled steroids in Covid-19:

    The links to the supporting studies are all included in the above review for reference. One study of particular note is the following which showed Ciclesonide had stronger antiviral effects than Remdesivir. It’s also widely available, has an excellent safety record, is available as a generic, and can be administered during antiviral stage when it can have the most effect (outpatient).

    There are 4 clinical trials currently registered for ciclesonide for Covid-19 treatment. However, the world doesn’t have time to wait for the results of these RCTs. The FDA should move immediately and issue an EUA for the use of this drug for Covid-19. The risks are minimal since it’s already an approved drug with a long safety record. This is the exact reason the EUA policy was created. It wasn’t created only to assist Big Pharma with fast tracking extremely expensive new drugs to market (with higher risk profiles). At the same time the NIH should divert some of the billions in new funding to assist the already progressing trials to reach a conclusion more expediently. If the existing trials aren’t designed to yield high enough quality evidence the additional NIH funding can be contingent on redesign so the outcome will be actionable i.e. adequately powered RCTs.