🇬🇧@COVID19Up: The University of Oxford announced on Wednesday that it would be testing ivermectin as a treatment for COVID-19 in its ongoing PRINCIPLE clinical study. While a Reuters article about the study gained significant attention on social media, supporters of the anti-parasitic drug immediately urged caution.
— Reuters (@Reuters) June 23, 2021
Wednesday’s announcement comes months after news first appeared suggesting the Oxford study would include ivermectin. A January 23, 2021 Bloomberg article referred to ivermectin as a “wonder drug” that Oxford University researchers were planning to study in a “large-scale trial of an inexpensive drug that could help dramatically reduce COVID-19 deaths globally.”
What this week’s brief Reuters piece fails to mention are the most important details of the study—who, what, and why—information that may have not been known when news first circulated regarding the study earlier this year.
The @UniofOxford IVM trial is garbage. They are enrolling only age 65+, up to 14 days after symptoms begin, and limiting to 3 days of IVM. They will end up enrolling severely ill high risk pts, and not treating them long enough.
They have carefully designed it to fail. As usual.
— Adam Gaertner 🇺🇸🇺🇸🇺🇸 (@veryvirology) June 23, 2021
Early critics of the study contend that it was designed to fail from the outset based on the information found in the Participant Information Leaflet dated February 22, 2021.
To be included in the trial, participants must be:
Aged 65 and over
Aged 18-64, and experiencing shortness of breath* as part of COVID-19 illness OR
Aged 18-64 with any of the following underlying health conditions:
a) Known weakened immune system due to a serious illness or medication (e.g. chemotherapy);
b) Known heart disease and/or a diagnosis of high blood pressure
c) Known chronic lung disease (e.g. asthma)
d) Known diabetes
e) Known mild hepatic impairment;
f) Known stroke or neurological problem;
g) Self-report obesity or body mass index ≥35 kg/m2
*Shortness of breath can make it hard to breathe deeply and you may feel winded or as if you can’t get enough air into your lungs. Unlike many other conditions that can cause shortness of breath, this symptom can persist and quickly escalate in people with COVID-19.
PRINCIPLE’s website simplifies the above information:
Rather than start with a random sample of the general population, this list of requirements for participation in the study includes only individuals that are already at greater risk.
According to Appendix 2 of the Participant Information Leaflet, participants will be given “an oral dose of 300 μg/kg body weight for 3 days.” The document also notes that “higher doses of 400 μg/kg for 5 days have been used in studies of COVID-19.”
According to research done thus far on ivermectin as a treatment for COVID-19, a dose of only 300 μg/kg for three days is inadequate. For example, the Front Line COVID-19 Critical Care Alliance (FLCCC) Prevention & Treatment Protocols for COVID-19 calls for a 24mg dose of ivermectin for five days in patients with body weight greater than 40kg for early at-home treatment.
For the sake of comparison, the Oxford study will provide a 40kg, ill, at-risk patient with 12mg of ivermectin for three days while the FLCCC recommends 24mg of ivermectin for five days for early at-home treatment in a seemingly healthy 40kg person.
It is important to note that the FLCCC’s recommended dose is for early at-home treatment. In people “in the setting of poor clinical response, advanced disease, or obesity,” the FLCCC stresses that higher doses should be used with a target of 0.4–0.6 mg/kg.
Let’s say the patient is of more average size (70 kg) and is suffering from advanced disease—a person that fits the trial participant criteria for PRINCIPLE. For this patient, the Oxford study would utilize a 21 mg dose of ivermectin for three days whereas the FLCCC recommendations would have a patient taking between 28-42 mg for at least five days. And it would not be unrealistic for that dosage to be prescribed daily until symptoms resolve.
The co-lead investigator of the trial, Chris Butler, explained, “By including ivermectin in a large-scale trial like PRINCIPLE, we hope to generate robust evidence to determine how effective the treatment is against COVID-19, and whether there are benefits or harms associated with its use.”
However, if the goal of PRINCIPLE truly were to determine how effective ivermectin is against COVID-19, they would be following the guidelines already set forth by a concerned group of doctors and scientists that have devoted significant time, energy, and resources to this very question.
More than the flaws and potential nefarious purposes of the Oxford study, the fact is that additional studies are not needed to prove that ivermectin is in fact a safe and effective treatment and prophylactic for SARS-CoV-2 and COVID-19, as noted by a newly published, peer-reviewed study.
And while the Oxford study is picking up steam and gaining more attention since their most recent announcement about ivermectin, it might not be the kind of attention they were hoping for.
.@UniofOxford needs to be called out, loudly, continuously and on every platform they use, about their doomed-to-fail IVM trial. It's designed for media fodder to permanently discredit IVM & murder patients.
This corruption cannot stand. Get involved. Help prevent this travesty.
— Adam Gaertner 🇺🇸🇺🇸🇺🇸 (@veryvirology) June 24, 2021
The Covid19 Assembly is seeking to halt Oxford’s study, saying, “We feel that it is being set up to fail in order to discredit ivermectin and similar treatments and prophylactics. However, as a result of discrediting ivermectin the study will likely cause the deaths of people who would otherwise have survived with established treatment.”
To learn more about ivermectin, check out the Front Line COVID-19 Critical Care Alliance (FLCCC) and the British Ivermectin Recommendation Development (BIRD) Group.
Can we say "Ivermectin" on social media now?https://t.co/fuB8ASHs7c
— Robert W Malone, MD (@RWMaloneMD) June 23, 2021