Randomized Trial for COVID
A RCT of NAC, Glutathione and Nutraceuticals Compared to Ivermectin in COVID-19. Stopping Ongoing Progression of Illness: The STOP COVID Trial
December 10th, 2020, IRB submission
Richard I. Horowitz, MD
Medical director, Hudson Valley Healing Arts Center
Board certified internal medicine
Member HHS Tick-borne Disease Working Group 2017-2019
Co-chair HHS Other Tick-borne Diseases and Co-infections subcommittee 2017-2019
Member, HHS Babesia and Other Tick-borne Pathogens 2019-2020
A hypothetical three-part prevention, diagnostic, and treatment approach based on an up-to-date scientific literature review for COVID-19 was published by Horowitz et al. in 2020.1 The primary hypothesis behind designing an effective prevention and treatment approach was based on the medical literature showing that infection, immune dysfunction, and inflammation (3 I’s) cause severe symptoms/clinical manifestations in COVID-19. Pathogenicity of COVID-19 has been linked in some patients to “Cytokine Storm Syndrome” (CSS) with “Acute Respiratory Distress Syndrome” (ARDS), which is the primary cause of death, along with fulminant myocarditis and multiorgan dysfunction. This results from an uncontrolled systemic inflammatory response with an increase in large amounts of pro-inflammatory cytokines (IFN-α, IFN-γ, IL-1β, IL-6, IL-12, IL-18, IL-33, TNF-α, TGFβ, etc.) & chemokines (CXCL9, CXCL10, etc.) by immune effector cells. 2 3 Recent scientific research has determined that not all patients who succumb to COVID-19 have evidence of a cytokine storm however, and the etiology underlying severe manifestations is still being investigated.
One hypothesis that urgently needs to be investigated in the pathogenesis of COVID-19 and severe manifestations including ARDS is glutathione deficiency. Endogenous deficiency of glutathione is considered by some authors to be a likely cause of serious manifestations and death in COVID-19 patients. 5 Glutathione (GSH) is the body’s primary antioxidant and has been shown to be deficient in viral, bacterial pneumonia & ARDS. 6 Based on the evidence attesting to the ability of glutathione (GSH) to inhibit viral replication and decrease levels of IL-6 in human immunodeficiency virus (HIV) and tuberculosis (TB) patients, as well as beneficial effects of GSH on other pulmonary diseases processes, the use of liposomal GSH has been hypothesized to be beneficial in COVID-19 patients. 7 No clinical studies on COVID patients have been performed to date however to prove the hypothesis.
Dr Horowitz has over a 20-year experience using glutathione in thousands of patients with Lyme disease, where glutathione helps lower inflammatory cytokines produced during Herxheimer reactions. 8 These are similar inflammatory cytokines seen in COVID-19,3 which is the basis for the Horowitz COVID protocol. The use of glutathione for COVID-19 has also been validated in a small pilot trial of 40 patients with COVID in his clinical practice, where patients reported a rapid improvement in symptoms following administration of oral glutathione, glutathione precursors (N-acetylcysteine), nutraceuticals (alpha lipoic acid, zinc, beta glucan) as well as ivermectin. No patients to date have required hospitalization. Two of those cases were published by Horowitz and Freeman in the Journal of Respiratory Case Reports in April 2020, which showed benefit using GSH for COVID-19 pneumonia, relieving dyspnea and associated symptoms, i.e., fatigue, myalgias, headaches.9 Since that time, the glutathione article by Horowitz et al. has been cited by 51 authors as a potential treatment for COVID-19 (https://scholar.google.com/scholar?rlz=1C1EJFC_enUS894US894&um=1&ie=UTF-8&lr&cites=9901749048605479286) without the benefit of proving the hypothesis via a RCT.