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Harlan Krumholz Profile picture
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4 Oct, 9 tweets, 6 min read
Very interested in @Regeneron therapy…2 non-competing neutralizing antibodies…one to receptor binding domain of the spike protein and one to the ACE receptor. They reported out early interim results for treatment of symptomatic people. Other studies pending Image
@Regeneron Inclusion criteria for the @Regeneron study was adult, non-hospitalized, symptoms <=7d, SARS-CoV-2 confirmed, and not on other COVID-19 therapies. Mean age was 44y. Half male. 42% obese. 7% (20 people) in the reported group were 65y and older.
@Regeneron The antibody cocktail to SARS-CoV-2 had a greater reduction in viral load for those whose viral load was higher at baseline. Image
@Regeneron The antibody treatment, in this interim analysis, seemed to resolve symptoms faster… but these are small numbers and admittedly an early look. And even w/high dose, about half have more than mild symptoms at a week. But early and interim. Image
@Regeneron For the antibody cocktail… the symptom benefit may be related to the baseline viral load. I am thinking about how this might be operationalized in practice. If this pans out, who would be treated? Would it be based on viral load? Image
@Regeneron No deaths so far in any of the groups studied in the reported interim results of the antibody cocktail for COVID-19. Including in the placebo group. Will really need to define well the risks and benefits of the treatment to understand its value. Look forward to more results.
@Regeneron And I do think @Regeneron presented a lot of data…but what makes the decision to present…and why not preprint rather than just through a press release. Preprint is a good alternative; a way to archive the results and make it easily available to the public. @medrxivpreprint
@Regeneron Here is the link to the @Regeneron presentation on their antibody cocktail. investor.regeneron.com/static-files/a… Image
@Regeneron And another important point from their interim analyses… they reported that viral load was higher in the seronegative group…and alleviation of symptoms better in seronegative group. I wonder if the President was seronegative. ImageImage

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More from @hmkyale

Harlan Krumholz Profile picture
24 Sep
On the #COVID19 transparency front: JNJ has announced that they will share the Clinical Study Report and clinical trial participant data from their vaccine trial with researchers through @Yale Open Data Access (YODA) Project. @YaleMed @jsross119 @JNJNews jnj.com/coronavirus/le…
@Yale @YaleMed @jsross119 @JNJNews To provide context for the JNJ vaccine data sharing, @Yale YODA Project provides access to data to researchers w/ credible scientific proposal, agreement to report results, & commitment to protect participant privacy. Access decision is independent. yoda.yale.edu
@Yale @YaleMed @jsross119 @JNJNews To date, @Yale Open Data Access (YODA) Project has resulted in 42 submitted publications (31 published) based on JNJ participant-level data sharing. JNJ (Janssen) has committed to sharing data from all their drug and device trials through the YODA project. jnj.com/coronavirus/ou…
Read 6 tweets
Harlan Krumholz Profile picture
16 Sep
Worth reading, policymakers please take note. “Vaccine hesitancy: why American values matter” The argument for transparency and independent evaluation in vaccine evaluation. Brillant and needed piece by @davidbeier1747 @LawrenceGostin @TomBollyky biocentury.com/article/630376 Image
@davidbeier1747 @LawrenceGostin @TomBollyky The authors 'We argue that two concrete policy steps could go a long way toward establishing public trust in COVID-19 vaccines:full and public disclosure of all data used to justify approval of a vaccine, and the creation of an independent and bipartisan committee to advise FDA.'
@davidbeier1747 @LawrenceGostin @TomBollyky They go on to say: 'We believe that the last chapter of this steeplechase will be whether enough people get vaccinated. Current and expected levels of vaccine hesitancy are far too high to end the pandemic.’
Read 5 tweets
Harlan Krumholz Profile picture
5 Sep
I had an early look @TimothyDSnyder new book ‘Our Malady: Lessons in Liberty from a Hospital Diary’ A raw, honest, disturbing (and personal) look at American medicine & politics… and a challenge to do better. I highly recommend it. amazon.com/gp/product/B08… @CrownPublishing Image
@TimothyDSnyder @CrownPublishing The book has some tough observations about my institution, which I love even though we are imperfect, and my colleagues, who I admire even as we are imperfect. But I see this book not as blame of individuals, but a call for a system that better elevates our work and humanity.
@TimothyDSnyder @CrownPublishing The book wraps the experience of a patient (the author) in the erudite perspective of one of our leading historians. We in healthcare almost always benefit from seeing through the patients’ eyes. He challenges us to elevate the system. And address what leads to disparities.
Read 4 tweets
Harlan Krumholz Profile picture
31 Aug
Fascinating and important paper by @VirusesImmunity and team on sex differences in immune response to COVID-19. nature.com/articles/s4158… @YaleMed
@VirusesImmunity @YaleMed What they found… “First... levels of several important proinflammatory innate immune chemokines and cytokines such as IL-8, IL-18 (at base-line), and CCL5 (longitudinal analysis) were higher in male patients, which correlated with higher non-classical monocytes (at baseline)."
@VirusesImmunity @YaleMed "Second, [they] observed a more robust T cell response among female patients compared to male patients at baseline. In particular, activated CD8 T cells were significantly elevated only in female patients but not in male patients over healthy volunteers."
Read 4 tweets
Harlan Krumholz Profile picture
30 Aug
The SGLT2 inhibitors are now officially not ‘diabetes’ medications, but also drugs capable of risk reduction for people with heart failure and reduced systolic function. And more than one option. All good news for patients. Now to ensure access. #ESCCongress #ESC2020 @TheLancet Image
@TheLancet The key thing about the meta-analysis of the SGLT2 inhibitors is that the primary endpoint was The primary endpoint was time to all-cause death. Not a composite. Not something needing adjudication. 13% reduction in allcause death (pooled HR 0·87, 95% CI 0·77–0·98; p=0·018).
@TheLancet The absolute difference in deaths was 1-2% range; but when you look across other outcomes, including hospitalizations, it is substantial. For adverse effects, interestingly, severe hypoglycaemic events was low, with
no increase in the active treatment groups in both trials.
Read 4 tweets
Harlan Krumholz Profile picture
27 Aug
Folks, this may bring privacy issues to the forefront. “@Apple says the iOS 14 change is intended to give people more control over the information they share with advertisers. Companies like @Facebook see it as something else: an attack on their business model.” @theinformation
@Apple @Facebook @theinformation "Facebook Inc. said privacy changes in Apple Inc.’s latest operating system would cripple its ability to place personalized ads and deal financial blow to app-makers, highlighting high-stakes clash between tech titans over rules of the road in mobile-internet economy.” @WSJ Image
@Apple @Facebook @theinformation @WSJ “Apple’s policy change is accelerating a paradigm shift—that was already well under way—towards consumers having rightful ownership and control over their data,” said Matt Littin, co-founder and CEO of gaming company Lootcakes. @vgblogger
Read 6 tweets

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