What if Lilly's monoclonal antibody trial was stopped due to futility?
1. A pause at 300 patients after 5 days of treatment was pre-specified in the protocol
nytimes.com/2020/10/13/hea… by @KatherineJWu @katie_thomas
2. Trials have stopping rules for 3 main reasons:
—futility (further enrollment would not show benefit)
—safety (the intervention appears to have a hazard that precludes further enrollment)
—efficacy (the efficacy evidence is overwhelming and it would not be ethical to proceed)
3. Since the pause was pre-specified and Lilly announced a "potential safety concern," we don't know yet if it was for futility or safety. So far there have not been safety issues disclosed for the monoclonal antibody programs w/ now thousands of patients enrolled (Ab or placebo)
4. If the trial was stopped for futility, is that a sign that monoclonal antibodies aren't working?
To answer that, take into account the indication--hospitalized patients w/ advanced covid illness, all receiving remdesivir, too.
The Phase 2 trials in outpatients were encouraging
5. Prior mAb studies in non-human primates indicate their capability to prevent illness given prophylactically, and to limit illness when given early after infection science.sciencemag.org/content/early/… @ScienceMagazine
6. So it could be that mAbs given too late are not helpful, perhaps even detrimental. This would be akin to what we've seen for dexamethasone and interferon to date. It could be a "timing is everything" story. We'll see. TBD

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More from @EricTopol

15 Oct
One monstrous wave, 3 phases, onto new heights, with no plan Image
Hospitalizations tracking with infections
@COVID19Tracking Image
Read 5 tweets
12 Oct
Covid reinfection in a 25 year-old man in Nevada, as confirmed by virus genomic sequencing; 2nd infection more severe @TheLancetInfDis
This is the 1st USA documented reinfection
Conclusion: "All individuals, whether previously diagnosed with COVID-19 or not, should take identical precautions to avoid infection w/ #SARSCoV2."
Several more global cases are in process of peer review now. Appears rare, but possible
This★ insightful commentary by @VirusesImmunity on the new reinfection case and the other 3 previously published pulls it all together, along with the known unknowns (a lot of those)
thelancet.com/journals/lanin… @TheLancetInfDis
Read 5 tweets
9 Oct
My interview with @US_FDA Commissioner @SteveFDA today @Medscape on the #SARSCoV2 vaccines, monoclonal antibodies, and rapid home tests 1/
Recall I had sent an open letter to him August 31 after the convalescent plasma "breakthrough" press conference, w/o any supportive evidence, and the prior EUA on hydroxychloroquine medscape.com/viewarticle/93…
He didn't take either option I suggested. He called me. 2/
We've since spoken several times and now I understand his intentions, what he's been through, the immense pressures that have been placed upon him. For me, the trust in him and the FDA has been restored. 3/
Read 18 tweets
8 Oct
Dr. Conley does it again. He clears Trump for public engagements in 2 days, without evidence that he is not infectious, without viral load data, without providing when/timeline he became infected.
Yesterday Dr. Conley ordered & reported a positive IgG antibody test in a patient who received a massive dose of IgG antibodies.
Today, without even committing to simple PCR tests to verify Trump is not shedding virus, he's cleared to meet with large crowds of unmasked people.
BTW CDC Guideline of 10 days (this is 9 days) is a *guideline*. This is a unique individual (in many ways) who received monoclonal antibodies, not expected to achieve mucosal immunity. And the early dexamethasone would suppress T cell response.
Read 4 tweets
8 Oct
We had the distinct privilege of talking with @cmyeaton about the pandemic, for which she has been a leading light. medscape.com/viewarticle/93…
w/ @cuttingforstone @Medscape w/ transcript
Here's some of the things we discussed and learned from @cmyeaton
1. What prompted her to become an epidemiologist?
2. Dr. Yeaton and colleagues wrote the essential report in April providing guidance for reopening. @JHSPH_CHS
If only the states had adhered to the guidelines, we could have achieved containment of the virus
Read 15 tweets
7 Oct
On today's message from Trump about his mAb treatment: "The gave me Regeneron" "at my suggestion" "I felt well immediately"
He now claims: "I call it a cure," "I've authorized the EUA" "Everyone will get them free"
All false. All predictable.
The things said were so far off the truth I made a tabular summary
Quotes from the video
More on monoclonals vs #SARSVoV2 and the unclear potential it had in this patient
Read 4 tweets

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