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Safety, Tolerability, and Pharmacokinetics of Escalating High Doses of Ivermectin in Healthy Adult Subjects

Guzzo et al., J. Clinical Pharmacology, doi:10.1177/009127002237994
Oct 2002  
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Ivermectin for COVID-19
4th treatment shown to reduce risk in August 2020
*, now known with p < 0.00000000001 from 100 studies, recognized in 22 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
3,800+ studies for 60+ treatments.
Safety study concluding that ivermectin was generally well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose. Adverse effects were similar between ivermectin and placebo and did not increase with dose. Authors also show that the plasma concentration is much higher when taken with food (geometric mean AUC 2.6 times higher).
Guzzo et al., 1 Oct 2002, peer-reviewed, 9 authors.
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Safety, Tolerability, and Pharmacokinetics of Escalating High Doses of Ivermectin in Healthy Adult Subjects
MD Cynthia A Guzzo, BS Christine I Furtek, PhD Arturo G Porras, PhD Cong Chen, MS Robert Tipping, Coleen M Clineschmidt, Dr David G Sciberras, John Y‐k. Hsieh, MD Kenneth C Lasseter
The Journal of Clinical Pharmacology, doi:10.1177/009127002237994
I vermectin is a derivative of the avermectins, a family of macrocyclic lactones produced by the filamentous bacterium Streptomyces avermitilis. It is a highly effective antihelmintic agent used in animals and humans. Ivermectin was first approved for human use in 1987 and is donated by Merck & Co., Inc., as Mectizan ® for the treatment of onchocerciasis and, more recently, lymphatic filariasis in Africa and Latin America. More
Addiss, Beach, Streit, Lutwick, Leconte et al., Randomized placebo-controlled comparison of ivermectin and albendazole alone and in combination for Wuchereria bancrofti microfilaremia in Haitian children, Lancet
Addiss, Eberhard, Lammie, Hitch, Spencer, Tolerance of single high-dose ivermectin for treatment of lymphatic filariasis, Trans R Soc Trop Med Hyg
Awadzi, Hero, Opoku, Buttner, Coventry et al., The chemotherapy of onchocerciasis: XVII. A clinical evaluation of albendazole in patients with onchocerciasis: effects of food and pretreatment with ivermectin on drug response and pharmacokinetics, Trop Med Parasitol
Baraka, Mahmoud, Marschke, Geary, Homeida et al., Ivermectin distribution in the plasma and tissues of patients infected with Onchocerca volvulus, Eur J Clin Pharmacol
Bell, Treatment of Pediculus humanus var. capitis infestation in Cowlitz county, Washington, with ivermectin and the Licemeister ® Comb, Pediatr Infect Dis J
Cartel, Nguyen, Moulia-Pelat, Plichart, Martin et al., Mass chemoprophylaxis of lymphatic filariasis with a single dose of ivermectin in a Polynesian community with a high Wuchereria bancrofti infection rate, Trans R Soc Trop Med Hyg
Cooper, Awadzi, Ottensen, Remick, Nutman, Eosinophil sequestration and activation are associated with the onset and severity of systemic adverse reactions following the treatment of onchocerciasis with ivermectin, J Infect Dis
Dunne, Malone, Whitworth, A field study of the effects of ivermectin on ectoparasites of man, Trans R Soc Trop Med Hyg
Ette, Thomas, Achumba, Ivermectin: a long-acting microfilaricidal agent, DICP
Fink, Porras, Pharmacokinetics of ivermectin in animals and humans
Glaziou, Nyguyen, Moulia-Pelat, Cartel, Martin, Efficacy of ivermectin for the treatment of head lice (Pediculosis capitis), Trop Med Parasitol
Hansen, Brogdon, Dillenberg, Gittes, Pollack et al., Guidelines for the treatment of resistant pediculosis, Contemporary Pediatrics
Ismail, Weil, Jayasinghe, Premaratne, Abeyewickrem et al., Prolonged clearance of microfilaraemia in patients with bancroftian filariasis after multiple high doses of ivermectin or diethylcarbamazine, Trans R Soc Trop Med Hyg
Krishna, Klotz, Determination of ivermectin in human plasma by high-performance liquid chromatography, Arzneimittelforschung
Kwan, Bohidar, Hwang, Estimation of an effective half-life
Martin-Prevel, Cosnefroy, Tshipamba, Ngari, Chodakewitz et al., Tolerance and efficacy of single highdose ivermectin for the treatment of loiasis, Am J Trop Med Hyg
Nguyen, Moulia-Pelat, Martin, Cartel, Advantages of ivermectin at a single dose of 400 mcg/kg compared with 100 mcg/kg for community treatment of lymphatic filariasis in Polynesia, Trans R Soc Trop Med Hyg
Njoo, Beek, Keukens, Van Wilgenburg, Oosting et al., Ivermectin detection in serum of onchocerciasis patients: relationship to adverse reactions, Am J Trop Med Hyg
Okonkwo, Ogbuokori, Ofoegbu, Klotz, Protein binding and ivermectin estimations in patients with onchocerciasis, Clin Pharmacol Ther
Richards, Eberhard, Bryan, Mcneeley, Lammie et al., Comparison of high dose ivermectin and diethylcarbamazine for activity against bancroftian filariasis in Haiti, Am J Trop Med Hyg
Van Den Enden, Gompel, Van Der Stuyft, Vervoort, Van Den Ende, Treatment failure of a single high dose of ivermectin for Mansonela perstans filariasis, Trans R Soc Trop Med Hyg
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