Regular Use of Ivermectin as Prophylaxis for COVID-19 Led Up to a 92% Reduction in COVID-19 Mortality Rate in a Dose-Response Manner: Results of a Prospective Observational Study of a Strictly Controlled Population of 88,012 Subjects

Article

作者: Baldi, Fernando ; Assagra, Washington Luiz ; Kory, Pierre ; Hibberd, Jennifer A ; Kerr, Lucy ; Proença, Fernando Carlos ; Cadegiani, Flavio A ; Lobo, Raysildo ; Chamie, Juan J

Background We have previously demonstrated that ivermectin used as prophylaxis for coronavirus disease 2019 (COVID-19), irrespective of the regularity, in a strictly controlled citywide program in Southern Brazil (Itajaí, Brazil), was associated with reductions in COVID-19 infection, hospitalization, and mortality rates. In this study, our objective was to determine if the regular use of ivermectin impacted the level of protection from COVID-19 and related outcomes, reinforcing the efficacy of ivermectin through the demonstration of a dose-response effect. Methods This exploratory analysis of a prospective observational study involved a program that used ivermectin at a dose of 0.2 mg/kg/day for two consecutive days, every 15 days, for 150 days. Regularity definitions were as follows: regular users had 180 mg or more of ivermectin and irregular users had up to 60 mg, in total, throughout the program. Comparisons were made between non-users (subjects who did not use ivermectin), and regular and irregular users after multivariate adjustments. The full city database was used to calculate and compare COVID-19 infection and the risk of dying from COVID-19. The COVID-19 database was used and propensity score matching (PSM) was employed for hospitalization and mortality rates. Results Among 223,128 subjects from the city of Itajaí, 159,560 were 18 years old or up and were not infected by COVID-19 until July 7, 2020, from which 45,716 (28.7%) did not use and 113,844 (71.3%) used ivermectin. Among ivermectin users, 33,971 (29.8%) used irregularly (up to 60 mg) and 8,325 (7.3%) used regularly (more than 180 mg). The remaining 71,548 participants were not included in the analysis. COVID-19 infection rate was 49% lower for regular users (3.40%) than non-users (6.64%) (risk rate (RR): 0.51; 95% CI: 0.45-0.58; p < 0.0001), and 25% lower than irregular users (4.54%) (RR: 0.75; 95% CI: 0.66-0.85; p < 0.0001). The infection rate was 32% lower for irregular users than non-users (RR: 0.68; 95% CI: 0.64-0.73; p < 0.0001). Among COVID-19 participants, regularusers were older and had a higher prevalence of type 2 diabetes and hypertension than irregular and non-users. After PSM, the matched analysis contained 283 subjects in each group of non-users and regular users, between regular users and irregular users, and 1,542 subjects between non-users and irregular users. The hospitalization rate was reduced by 100% in regular users compared to both irregular users and non-users (p < 0.0001), and by 29% among irregular users compared to non-users (RR: 0.781; 95% CI: 0.49-1.05; p = 0.099). Mortality rate was 92% lower in regular users than non-users (RR: 0.08; 95% CI: 0.02-0.35; p = 0.0008) and 84% lower than irregular users (RR: 0.16; 95% CI: 0.04-0.71; p = 0.016), while irregular users had a 37% lower mortality rate reduction than non-users (RR: 0.67; 95% CI: 0.40-0.99; p = 0.049). Risk of dying from COVID-19 was 86% lower among regular users than non-users (RR: 0.14; 95% CI: 0.03-0.57; p = 0.006), and 72% lower than irregular users (RR: 0.28; 95% CI: 0.07-1.18; p = 0.083), while irregular users had a 51% reduction compared to non-users (RR: 0.49; 95% CI: 0.32-0.76; p = 0.001). Conclusion Non-use of ivermectin was associated with a 12.5-fold increase in mortality rate and a seven-fold increased risk of dying from COVID-19 compared to the regular use of ivermectin. This dose-response efficacy reinforces the prophylactic effects of ivermectin against COVID-19.

2022-08-11·Cureus

Catecholamines Are the Key Trigger of COVID-19 mRNA Vaccine-Induced Myocarditis: A Compelling Hypothesis Supported by Epidemiological, Anatomopathological, Molecular, and Physiological Findings

Review

作者: Cadegiani, Flavio A

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccine-induced myocarditis is a rare but well-documented complication in young males. The increased incidence of sudden death among athletes following vaccination has been reported and requires further investigation. Whether the risk of myocarditis, a known major cause of sudden death in young male athletes, also increases after coronavirus disease 2019 (COVID-19) infection is unknown. The severity and implications of these critical adverse effects require a thorough analysis to elucidate their key triggering mechanisms. The present review aimed to evaluate whether there is a justification to hypothesize that catecholamines in a "hypercatecholaminergic" state are the key trigger of SARS-CoV-2 mRNA vaccine-induced myocarditis and related outcomes and whether similar risks are also present following COVID-19 infection. A thorough, structured scoping review of the literature was performed to build the hypothesis through three pillars: detection of myocarditis risk, potential alterations and abnormalities identified after SARS-CoV-2 mRNA vaccination or COVID-19 infection and consequent events, and physiological characteristics of the most affected population. The following terms were searched in indexed and non-indexed peer review articles and recent preprints (<12 months): agent, "SARS-CoV-2" or "COVID-19"; event, "myocarditis" or "sudden death(s)" or "myocarditis+sudden death(s)" or "cardiac event(s)"; underlying cause, "mRNA" or "spike protein" or "infection" or "vaccine"; proposed trigger, "catecholamine(s)" or "adrenaline" or "epinephrine" or "noradrenaline" or "norepinephrine" or "testosterone"; and affected population, "young male(s)" or "athlete(s)." The rationale and data that supported the hypothesis were as follows: SARS-CoV-2 mRNA vaccine-induced myocarditis primarily affected young males, while the risk was not observed following COVID-19 infection; independent autopsies or biopsies of patients who presented post-SARS-CoV-2 mRNA vaccine myocarditis in different geographical regions enabled the conclusion that a primary hypercatecholaminergic state was the key trigger of these events; SARS-CoV-2 mRNA was densely present, and SARS-CoV-2 spike protein was progressively produced in adrenal medulla chromaffin cells, which are responsible for catecholamine production; the dihydroxyphenylalanine decarboxylase enzyme that converts dopamine into noradrenaline was overexpressed in the presence of SARS-CoV-2 mRNA, leading to enhanced noradrenaline activity; catecholamine responses were physiologically higher in young adults and males than in other populations; catecholamine responses and resting catecholamine production were higher in male athletes than in non-athletes; catecholamine responses to stress and its sensitivity were enhanced in the presence of androgens; and catecholamine expressions in young male athletes were already high at baseline, were higher following vaccination, and were higher than those in non-vaccinated athletes. The epidemiological, autopsy, molecular, and physiological findings unanimously and strongly suggest that a hypercatecholaminergic state is the critical trigger of the rare cases of myocarditis due to components from SARS-CoV-2, potentially increasing sudden deaths among elite male athletes.

2022-08-01·Journal of the American Academy of Dermatology

Circulation, sensation, and hair growth: A reply

Letter

作者: Goren, Andy ; Cavanagh, Gregory ; Wambier, Carlos Gustavo

项与 Applied Biology, Inc. 相关的新闻（医药）

2022-06-21

·BioSpace

Jupiter Wellness Acquires the Assets of Applied Biology Inc., a Leading Biotechnology Company Specializing in Hair and Skin Science

Assets include issued patents, patent applications, products, clinical trial results, licensing agreements Applied Biology generated approximately $8 million in revenues and $3 million in EBITDA in 2021 (unaudited) Regulatory expertise with US FDA, EMA, KFDA (Korea), PMDA (Japan), ANVISA (Brazil), CFDA (China) JUPITER, FL / ACCESSWIRE / June 21, 2022 / Jupiter Wellness, Inc. (Nasdaq:JUPW) today announced the acquisition of 100% of the assets of Applied Biology, Inc. a leading biotechnology company specializing in hair and skin science, for up to 4 million shares of Jupiter Wellness stock deliverable upon completion of certain milestones. Applied Biology is a developer of breakthrough drugs and medical devices for the treatment of skin and hair disorders. Led by the foremost thought leaders in their fields, the company's R&D pipeline of novel pharmaceuticals is focused on hair and skin conditions as well as women's health and COVID-19. They have several products in development from pre-clinical to advanced stages. Applied Biology has provided clinical research, IP development, and regulatory services to healthcare companies worldwide through a global network of clinical sites to advance its proprietary therapies and products. Before the acquisition, Jupiter Wellness and Applied Biology had well-established and ongoing collaborations including Jupiter Wellness's exclusive license for Applied Biology's Photocil™ psoriasis treatment in the United States, as well as Applied Biology serving as the clinical research organization for several of Jupiter Wellness's proprietary cannabidiol dermatological treatment candidates. Acquisition Highlights Expected to Accelerate Top and Bottom-line Growth: Jupiter Wellness expects Applied Biology's financial performance to at once contribute to Jupiter Wellness's financial results. With the potential of adding up to $8 million in revenues and $3 million in EBITDA on an annualized basis (based on 2021 unaudited financials) Acceleration and Expansion of Development Pipeline: The acquisition expands Jupiter Wellness's pipeline to additional dermatology drugs in various stages of clinical and preclinical development. Applied Biology brings the following portfolio: Alopecia - pipeline for the treatment of traction alopecia, androgenetic alopecia, and chemotherapy-induced alopecia. Psoriasis - A topical treatment for psoriasis to be launched in late 2022. Women's Health - A novel treatment for female sexual dysfunction in the clinical stage was recently granted 2 patents Adds Exceptional Clinical, Regulatory Expertise, and Human Capital: Led by Prof. Andy Goren, Applied Biology's management team and medical board bring a deep expertise from concept through clinical development to commercialization, a key strategic asset for Jupiter with access to eight major dermatological hospitals around the world. Prof. Andy Goren will become Chief Medical Officer of Jupiter Wellness, and John McCoy PhD will become Vice-President of R&D. Commercialized Products: Photocil - Jupiter Wellness gains worldwide rights to patented Photocil, a novel topical treatment for psoriasis, vitiligo, pruritis, and atopic dermatitis. Jupiter Wellness had previously licensed the exclusive rights to market Photocil in the U.S. where it plans to launch the product in Q4 2022. With the acquisition, Jupiter Wellness now owns all rights to Photocil which is approved and commercialized in Europe, Asia, and the Middle East. Minoxidil Booster - Minoxidil Booster greatly improves the efficacy of minoxidil (from 30% to 60%+) by enhancing the generation of minoxidil sulfate, the active drug. Several licensing and distribution agreements for this product have been signed. Adds Robust IP Estate: Applied Biology's IP portfolio includes 35 patent applications and three issued U.S. patents for: Photocil: Methods and Compositions for Administering a Specific Wavelength Phototherapy COVID-19 and Respiratory Infection Treatment: Systems, Methods, and Kits for Diagnostics and Treatment of Viral Respiratory Infection Women's Health: Treatment of Sexual Dysfunction "Jupiter Wellness has enjoyed a highly productive and long-term business relationship with Applied Biology and we are excited to welcome Prof. Andy Goren and his talented team to Jupiter. This highly synergistic asset purchase leverages Jupiter Wellness's current clinical development pipeline and adds tremendous clinical, IP, and regulatory expertise, access to patients and clinical sites worldwide, and positions us with meaningful growing revenues and EBITDA," said Jupiter Wellness CEO Brian John. About Jupiter Wellness Jupiter Wellness translates innovative health science into revolutionary products aimed at skin, hair, sexual wellness, and general health. Our approach is defined by proven mechanisms of action, validated manufacturing processes, and controlled clinical trials. Our development pipeline includes products to address psoriasis, eczema, burns, herpes, cold sores, and skin cancer. Jupiter Wellness generates revenue from a growing line of over-the-counter skin care products, wellness brands sold through retail channels, and the licensing of our intellectual property and proprietary formulations. For more information, please visit Investor Contact Phone: 561-462-2626 Email: investors@jupiterwellness.com Forward-Looking Statements This communication contains forward-looking statements regarding Jupiter Wellness, including, the anticipated timing of studies and the results and benefits thereof. You can generally identify forward-looking statements by the use of forward-looking terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "explore," "evaluate," "intend," "may," "might," "plan," "potential," "predict," "project," "seek," "should," or "will," or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are based on each of the Company's current plans, objectives, estimates, expectations, and intentions and inherently involve significant risks and uncertainties, many of which are beyond Jupiter Wellness' control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties and other risks and uncertainties affecting Jupiter Wellness, including those described from time to time under the caption "Risk Factors" and elsewhere in Jupiter Wellness' Securities and Exchange Commission (SEC) filings and reports, including Jupiter Wellness' Annual Report on Form 10-K for the year ended December 31, 2021, and future filings and reports by Jupiter Wellness. Moreover, other risks and uncertainties of which the combined company is not currently aware may also affect each of the companies' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. Investors are cautioned that forward-looking statements are not guarantees of future performance. The forward-looking statements made in this communication are made only as of the date hereof or as of the dates indicated in the forward-looking statements and reflect the views stated therein with respect to future events at such dates, even if they are subsequently made available by Jupiter Wellness on its website or otherwise. Jupiter Wellness undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date on which the forward-looking statements were made. SOURCE: Jupiter Wellness, Inc. View source version on accesswire.com:

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