I’ve been following the research on experimental therapies to treat #covid19 from the beginning and in the last month the three biggest results came from just one trial: Recovery in the UK. Why is that? My story here and quick thread to come: sciencemag.org/news/2020/07/o…
The UK trial has delivered robust negative results on hydroxychloroquine (a malaria medication) and lopinavir/ritonavir (an HIV medication) and a robust positive result on dexamethasone (a steroid). Caveat: Only the dexamethasone results have been published as a preprint so far.
How did it get those results so fast:
- simple design focusing on mortality
- enrolment and data collection kept easy
- supported by a national health service
- UK explicitly prioritized the trial over others, urging doctors to enrol patients
- UK had a lot of #covid19 cases
- simple design focusing on mortality
- enrolment and data collection kept easy
- supported by a national health service
- UK explicitly prioritized the trial over others, urging doctors to enrol patients
- UK had a lot of #covid19 cases
That has allowed Recovery to become the largest #covid19 treatment trial in the world. About 12,000 patients have been enrolled so far. One in six #covid19 patients that go to hospital in the UK end up in the trial, @MartinLandray told me. So what are the lessons?
When it comes to clinical trials, size matters. Scientists agree that what is needed to get robust results fast are large, randomized trials. “Everybody has the first part about ‘randomized,’ but they omitted the ‘large’ part”, Ana-Maria Henao Restrepo of @WHO told me.
Instead there have been hundreds of small studies that can provide important data but will not definitively answer a question. Take the US: It has had 1/4 of all reported #covid19 cases. But only one large, ramdomized trial (NIH’s ACTT trial) has yielded an important answer.
What is needed (and this is a consistent pattern in almost everything in this pandemic) is more coordination and collaboration. Basically: one trial with 5000 patients is way more valuable to the world than 50 trials with 100 patients or 5000 case reports.
That goes nationally as well as internationally. The other huge trial that is going on is @WHO’s Solidarity which has enrolled 5500 patients around the globe. But the trial struggled to get off the ground in part because it needed to be approved by dozens of regulatory agencies.
“That has taken a surprisingly long time in many jurisdictions, including in Europe,” @jarottingen told me. “When countries were ready to sort of start, the epidemic was under control in many ways.” The world should learn from that as it prepares for the next pandemic (or wave).
For now: Recovery may well provide more important results. It is continuing to test azithromycin, tocilizumab and convalescent plasma. But recruitment has slowed significantly as case numbers have come down in the UK.
As the pandemic moves around the globe, Solidarity (approved in more than 30 countries and more joining) is in a good position to generate robust results as well. So the question moving to the front now: What are the next therapies it should test?
