The Case for Human Challenge Trials in COVID-19

Area of Science:

• Infectious Diseases
• Medical Ethics
• Clinical Trials

Background:

• The COVID-19 pandemic spurred urgent research for disease comprehension and novel therapeutics.
• Controlled Human Infection Trials (CHITs) represent a potential avenue for rapid research.
• Historical precedents for deliberate human infection and CHITs exist prior to the COVID-19 era.

Purpose of the Study:

• To examine the history and prior utilization of CHITs.
• To analyze key ethical considerations for CHITs within the COVID-19 pandemic context.
• To review the World Health Organization's (WHO) criteria for ethical COVID-19 human challenge studies and assess compliance in commenced trials.

Main Methods:

• Historical review of deliberate human infection and CHITs.
• Analysis of ethical frameworks and guidelines, specifically the WHO's criteria.
• Case study review of two initiated COVID-19 CHITs, evaluating their adherence to ethical standards and WHO criteria.

Main Results:

• CHITs have a historical basis predating the COVID-19 pandemic.
• Specific ethical challenges arise in the context of COVID-19 CHITs.
• An assessment of two COVID-19 CHITs indicates their compliance with WHO criteria and ethical considerations.

Conclusions:

• CHITs offer a valuable model for accelerating COVID-19 research.
• Ethical considerations are paramount in the design and execution of COVID-19 CHITs.
• The WHO criteria provide a framework for ensuring the ethical acceptability of these studies.