Ivermectin sales in Valle del Cauca, Colombia, patterns of AEs, and other background re López-Medina et al. 2021

Abstract: Supplementary data re López-Medina et al. 2021 David E Scheim a Table S1. Sales of Ivermectin in liquid and capsule form in the Colombian state of Valle del Cauca, encompassing the study region, from January 2019 through November 2020.1 Units of liquid IVM were bottles each containing 5 ml of 0.6% IVM, and units of capsules were blister packs of 7 pills, 3 mg each. On July 9, 2020, a week before the LopezMedina et al. study began recruiting patients in Cali, its mayor, Jorge Iván Ospina, announced that his city would begin distributing 10,000 doses of IVM to COVID-19 patients the following day. With IVM available over the counter (OTC) in Colombia without prescription, sales of IVM quintupled in Valle del Cauca from June to July 2020. Sales of IVM during the study period of July through November 2020 totaled 154,919 units (each unit about one dose), 1.6 times the number of COVID-19 cases (95,387, see Table S2) during that period. Month Capsules Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2019 Liquid 0 0 0 0 0 0 0 0 0 0 0 0 Capsules 2,745 2,980 3,406 4,387 4,076 4,109 4,727 3,938 3,548 3,915 4,225 3,206 2020 Liquid 0 0 0 0 0 0 935 3,463 821 757 949 — 4,131 4,541 2,910 9,850 8,293 10,503 48,943 34,228 15,887 21,093 27,843 — Table S2. COVID-19 cases in the Colombian state of Valle del Cauca, encompassing the study region, from June through December 2020, by month.2 Month Number of cases June 2020 6,365 Jul 2020 14,432 Aug 2020 21,785 Sept 2020 15,172 Oct 2020 20,072 Nov 2020 23,926 Dec 2020 28,165 Table S3. Summary of adverse effects associated with IVM as reported in eTable 7 of López-Medina et al. Adverse event Ivermectin (n=275) Placebo (n=198) Dizziness (number, %) 98 (35.6%) 68 (34.3%) Diarrhea (#, %) 83 (30.2%) 65 (32.8%) Nausea #, %) 66 (24.0%) 47 (23.7%) Disturbances of vision, any (#, %) 44 (16.0%) 28 (14.1%) Photophobia (#, %) 9 (3.3%) 4 (2.0%) Blurry vision (#, %) 31 (11.3%) 23 (11.6%) David E. Scheim, PhD (email: dscheim@alum.mit.edu) is a commissioned officer in the US Public Health Service, inactive reserve. a Page 1 of 4 Figure S1. Google trends for ivermectina v. vacuna covid in the Colombian state of Valle del Cauca, encompassing the study region, during and prior to the Lopez-Medina study enrollment period of July 15 through November 30, 2020. The number of Google searches for ivermectina (Spanish for ivermectin) spiked from 2 times to 33 times that for COVID vaccine (vacuna covid) from the last week in June to the first week of July 2020. The total number of searches for ivermectina in the weeks beginning July through November 2020 was 2.7 times greater than that number for vacuna covid.3 Table S3. Timeline of breaches of boundaries between treatment and placebo groups in Lopez-Medina et al. Date Event Source Oct. 20, 2020 “On October 20, 2020, the lead pharmacist observed that a labeling error had occurred between September 29 and October 15, 2020, resulting in all patients receiving ivermectin and none receiving placebo during this time frame.” This affected 75 patients, 38 of which were randomized to receive placebo. These 75 patients were excluded in the analysis for the primary endpoint but included in several other tables presented in supplement 2. Main study paper, p. 3; study protocol, p. 43 Aug 26, 2020 This is the date through which “the placebo was a mixture of 5% dextrose in saline and 5% dextrose in distilled water.” This placebo solution was used for the..