The COVID-19 pandemic has created an urgent need to develop a safe and effective vaccine. Currently, research groups around the world are working to develop more than 90 investigational vaccine candidates. While several vaccine candidates are already being tested in clinical trials, there are still critical unanswered questions around the expected clinical effectiveness of immunization. How long will protection last? What inoculation dose and regimen is needed? Which vaccine platform will provide optimal comparative effectiveness (classical strategies of weakened viral particles or components versus the various RNA and DNA vaccine strategies)?
With a vaccine likely a year or longer away, there is urgency around determining the right therapeutic at the right dose to fight COVID-19. Results from clinical trials of monotherapies have been a mixed bag to date, and there has not been a clear leading and proven therapeutic in this race. Monotherapy treatment must be initiated very early in viral infection and be quite potent. A combination therapy where different steps of the SARS-CoV-2 life cycle are modestly impacted may be a better strategy. A cocktail of antiviral drugs or a mix of antivirals and anti-inflammatory medicines could be more effective against COVID-19 than monotherapies, which is what we learned with HIV. We propose that combinations of drugs that act at multiple sites in the viral life cycle should be evaluated in randomized controlled clinical trials.
Watch this webinar to learn about tools & processes to help tailor COVID-19 therapies for special populations, including children and pregnant women
Considerations for Management of Clinical Trials and Regulatory Filing Strategy in Light of COVID-19
COVID-19 has the potential to negatively impact critical activities such as patient recruitment, patient safety and ensuring data integrity. Thus, clinical developers should review their planned regulatory filing strategies to determine if modifications are required. Attend this webinar to learn mitigation strategies and best practices that you can begin implementing now.
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