Ivermectin Trials Were Designed to Fail
The Epoch Times has reported that the studies that show that Ivermectin is ineffective against COVID were designed to fail by instructing users to take too little at the wrong times. This isn’t science, this is conspiracy.
Recommended Dosage
According to Merck’s package insert for ivermectin (brand name Stromectol), a single oral dose of 0.2 mg/kg was officially recommended for treating parasitic diseases. There is no official dose for COVID-19.
The recommended dosage of ivermectin for treating COVID-19 is based on the clinical experiences of physicians worldwide.
The Front Line COVID-19 Critical Care Alliance (FLCCC) guidelines recommend taking 0.4 mg/kg of ivermectin daily, immediately after exposure. Once a cumulative dose in excess of 200 mg is reached, the risk of acquiring COVID-19 has been shown to be nearly zero.
It is common for a drug with multiple indications to have different doses for different diseases.
Moreover, ivermectin should be given with food, as it has a 2.6-fold higher bioavailability when taken with food rather than on an empty stomach. The Merck package insert (revised May 2022) also supports this and states: “Administration of 30 mg ivermectin following a high-fat meal resulted in an approximate 2.5-fold increase in bioavailability relative to administration of 30 mg ivermectin in the fasted state.”
FLCCC guidelines also recommend taking ivermectin “with or just following a meal for greater absorption.”
Yet this important dosing information is not reflected in the commonly used drug prescribing resource known as the Prescribers’ Digital Reference or PDR which states: “Take the number of tablets your doctor has prescribed all at the same time with water on an empty stomach. Do not eat any food within two hours before or after taking the tablets.”
So if a person takes the dose while fasting, they are getting only 40 percent of the recommended dose. For patients with a higher body weight, the effects of underdosing could be even more significant.
RCT Studies Used Inappropriate Dosing
In the most recent PRINCIPLE trial published in March, ivermectin was used at 0.3 mg/kg for only three days. Moreover, it was designed to dose the ivermectin without food: “Participants were advised not to eat two hours before or after taking ivermectin.”
In another RCT ACTIV-6 published in JAMA in October 2022, ivermectin was dosed in a fasting status, as the protocol stated: “Ivermectin should be taken on an empty stomach with water (30 minutes before a meal or 2 hours after a meal).”
Ivermectin was reported as dosed at 0.4 mg/kg for three days—a much shorter time period than it should be. However, in the protocol Table 4 in Appendix 16.3.3, the precise dosing was as low as 0.269 mg/kg, and 0.4 mg/kg is actually only the upper dose limit—not the real dose.
According to the worldwide recognized study guideline ICH Good Clinical Practice, clinical trials must adhere to ethical principles. Failure to do so would be considered study misconduct or fraud and would violate the principle of integrity.
Another JAMA study published in March 2021 repeated the same mistake in mild COVID-19 patients by suggesting they take 0.3 mg/kg for five days on an empty stomach.
An RCT study known as TOGETHER, published in March 2022 in the New England Journal of Medicine, underdosed ivermectin with 0.4 mg/kg for only three days and did not mention dosing with food.
Nevertheless, even at this low dose, the ivermectin still reduced hospitalization rates, death, and the need for mechanical ventilation compared to a placebo.
