The world has to take a multipronged approach to tackling COVID-19. We should work to identify effective repurposed drugs, validate experimental drugs, develop new drugs, test early treatments, test late treatments, try convalescent serums and invest in vaccines. We must do all of this in parallel to end the pandemic.
CETF fills a gap in existing research efforts. We are laser-focused on identifying existing drugs that can be used to effectively treat COVID-19 early. These key principles guide our approach:
1. Treat early with antivirals. The earlier antiviral medicines are administered, the more effective they will be in combatting viral replication in the body.
2. Focus on existing drugs. Repurposing existing drugs is the fastest path to an effective COVID-19 treatment that could prevent tens of thousands of hospitalizations and deaths. These drugs have already gone through extensive safety testing, so their side effects are well known. Because they are already on the market, they will be much faster to mass-produce than new drugs.
3. Take a portfolio approach. Funding an array of well-designed outpatient clinical trials in parallel is the fastest way to identify which existing drugs work to treat COVID-19 and which ones don’t.
4. Remember that drug, dose and timing are intertwined. For any drug taken for any disease, the drug(s) chosen, the dose given, and the timing all matter significantly. If any one of the three parameters is off, it can mean the difference between overwhelming success and abject failure.
5. Select the most promising trials. Our Scientific Advisory Board (SAB) is an unmatched team of top physicians and scientists with diverse and complementary expertise. All funded trials go through a rigorous review process by the SAB before being approved. Our board has no vested interest in any public or private entity to ensure objectivity.
6. Set up trials to withstand scrutiny. Clinical trials should adhere to the highest testing standards. This means double-blinded, randomized controlled trials with peer-reviewed results. Further, when a trial identifies an effective drug, it should become the new control (which is standard for adaptive trials). This will encourage more people to sign up for trials since everyone will know they will, at a minimum, receive a more effective treatment than the previous standard of care.
7. Support trial recruitment and retention. Outpatient clinical trials should be heavily promoted to recruit participants quickly. This leads to faster completion and more actionable data, at a lower cost.
8. Test all the most promising early treatments. A single, multi-institution adaptive randomized controlled trial testing all the candidates is ideal. There should be one multi-institution, multi-arm randomized controlled adaptive clinical trial on the entire set of most promising drugs with the largest enrollment, in order to test all the drugs simultaneously. Once we understand the singleton effects, we can intelligently combine the best drugs and optimize dosing.
9. Use next-generation sequencing (NGS). There can be virus variants and human variants that lead to better or worse outcomes, and we can use that information to triage which patients should be treated and with what therapies. More work is needed to tie NGS data to patient outcomes and analyze the data to find patterns.
10. Politics shouldn’t play a role in this. This virus isn’t political. We are focused on using science to lead us out of this problem by identifying the most effective existing drugs to treat the virus early.