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It's safe to say 2020 has been "a challenge."

Scientists in the U.K. are about to take that expression to an entirely new level.

Researchers from an organization called "Open Orphan" have announced plans for a so-called "challenge study" where volunteers will be intentionally exposed to SARS-CoV-2.

Tell Me More
In a normal Phase 3 efficacy trial, patients are given either a vaccine or placebo and are left to go about their regular lives to see if they contract the disease. With enough data, scientists can determine if the vaccine is effective.

Challenge studies are more "to the point."

How It'll Work: First, volunteers between the ages of 18 to 30 will participate in what's known as “virus characterization.” In essence, patients will be gradually exposed to higher and higher levels of SARS-CoV-2 until they reach a level that "reliably infects the upper respiratory tract."

Second, once the infective level of the virus has been determined, the challenge trials will begin. While the exact trial design has not been finalized, a different set of participants is expected to receive either a vaccine or a placebo. Patients will then be intentionally exposed to the virus to quickly determine if the vaccine is protective.

The study will take place at a special biocontainment suite at the Royal Free Hospital in London.

Safety First: Trial organizers say every effort will be undertaken to ensure safety:

  • Volunteers will be treated with an antiviral (such as remdesevir) once a nasal swab yields a positive result for SARS-CoV-2 genetic material.
  • In addition to age and health, participants will be screened for risk factors that have been associated with severe COVID-19.

Stepping Back
Challenge trials have a long history of being used to develop treatments for diseases including typhoid, cholera, and malaria. But they are less commonly used in emerging diseases with limited available treatment.

1Day Sooner, a U.S. advocacy group, has signed up more than 38,500 eager participants who would like to participate in a challenge study.

If Open Orphan receives approval from various regulatory and ethical bodies, it will aim to recruit roughly 500 participants for the various phases of the work.

The Takeaway: Participants will be paid £4,000 for their time and trouble.



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