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June 23, 2021updated 12 Jul 2022 11:06am

Oxford University adds ivermectin to PRINCIPLE trial for Covid-19

Ivermectin is a broad spectrum antiparasitic that reduced SARS-CoV-2 replication in laboratory studies.

The University of Oxford in the UK has added ivermectin to the Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses (PRINCIPLE) study for the treatment of Covid-19.

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PRINCIPLE is a large clinical trial designed to assess potential Covid-19 therapies for non-hospitalised patients, including at-home recovery, who are at higher risk of progressing to serious illness.

Ivermectin is broad spectrum antiparasitic used commonly to treat parasitic infections worldwide.

The drug, which is known to exhibit antiviral properties, reduced SARS-CoV-2 replication in laboratory studies.

In small pilot studies, early use of ivermectin was able to lower viral load and the duration of symptoms in some mild Covid-19 patients.

The drug is used routinely to treat Covid-19 in some countries, but only a little data from large-scale randomised controlled clinical trials are available to validate its effect on recovery speed or decreasing hospitalisation.

PRINCIPLE trial joint chief investigator professor Chris Butler said: “Ivermectin is readily available globally, has been in wide use for many other infectious conditions so it’s a well-known medicine with a good safety profile, and because of the early promising results in some studies it is already being widely used to treat Covid-19 in several countries.

“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.”

Participants will be given a three-day ivermectin course and followed up for 28 days. The trial will compare the drug to the usual standard of NHS care.

Individuals aged 18 to 64 years with some underlying health conditions or shortness of breath from Covid-19, or those aged above 65 years, can participate in the trial.

The trial will enrol subjects within the initial 14 days of Covid-19 symptoms or a positive test.

However, individuals with severe liver disease who are taking the blood-thinning drug warfarin, or other therapies known to interact with ivermectin, will not be eligible.

Ivermectin is the seventh therapy to be evaluated in the PRINCIPLE study, along with the influenza antiviral favipiravir.

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As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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