In this episode we tackle treatment with remdesivir, management with anticoagulation, and presymptomatic transmission. Welcome back to COVID Cakes, a rundown of recent COVID articles and news stories. What does the latest Gilead medication have to offer? Why should we wear masks? And if you thought 6 feet was THE safe distance…we’ve got some bad news about running. But it’s not all bad! We’re joined by everyone’s favorite Curbsider/Internist/Epidemiologist, Rahul Ganatra MD MPH (@rbganatra), who provides critical appraisal of the newest COVID-19 treatment article. Pull up a chair, bring your own syrup, and join us!
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**Updates: 1) NIH Press Release about Remdesivir RCT with accelerated recovery from April 27, 2020. 2) Wang Y et al article from Lancet published April 29, 2020.**
Grein, J et al. Compassionate Use of Remdesivir for Patients with Severe Covid-19. NEJM. April 10, 2020 [https://www.nejm.org/doi/full/10.1056/NEJMoa2007016]
For a step-by-step breakdown of the study, follow along with Dr Ganatra (@rbganatra) on his twitter learning thread, #HowIReadThisPaper.
Think about how data get in and come out of any study. How patients (and their data) get in is all about patient selection (and selection bias), and how data comes out is all about ascertainment (and ascertainment bias).
Even though the primary results of this study were descriptive, meaning no comparison was done, are there still sources of bias that could threaten the authors’ conclusion that remdesivir is promising? Yes.
Sources of selection bias: The denominator (how many total compassionate use applications submitted) is unknown, time from symptom onset to treatment was 12 days (meaning patients had to survive the first 12 days of COVID-19), and 8 patients contributed no follow-up data.
Sources of ascertainment bias: The likelihood of having complete follow-up data depended on how sick patients were – all patients with mild disease at enrollment achieved clinical improvement or discharge; 8 patients with severe disease (requiring ECMO or intubation) achieved neither clinical improvement, discharge, or death by day 28.
Without a control group, it is impossible to tell whether the observed outcomes in this selected population are due to RDV. Selection bias limits both comparison to other cohorts and the generalizability of these results. Well-designed RCTs are needed.
Thachil J et al. ISTH interim guidance on recognition and management of coagulopathy in COVID19. J Thromb Haemost. 25 March 2020 [https://onlinelibrary.wiley.com/doi/epdf/10.1111/jth.14810]
Tang, N et al. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 27 March 2020. [https://onlinelibrary.wiley.com/doi/abs/10.1111/jth.14817]
Anticoagulation policies vary widely, from prophylactic to treatment dosing for hospitalized patients, depending on institution. We recommend that you follow your institutions guidelines until we have more data to guide practice.
Sutton D et al. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. NEJM. 13 April 2020. [https://www.nejm.org/doi/full/10.1056/NEJMc2009316]
He, X et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nature Medicine. 15 April 2020. [https://www.nature.com/articles/s41591-020-0869-5]
Leung N et al. Respiratory virus shedding in exhaled breath and efficacy of face masks. Nature Medicine. 2 April 2020 [https://www.nature.com/articles/s41591-020-0843-2]
Bae S et al. Effectiveness of surgical and cotton masks in blocking SARS–CoV-2: A controlled comparison in 4 patients. Annals of Internal Medicine. 6 April 2020. [https://annals.org/aim/fullarticle/2764367]
Antibody testing : Letter from FDA summarized (Jwatch summary)
Seroprevalence study from Santa Clara, CA (MedRxiv study):
“Don’t just do something, stand there” – advice from Paul Sax blog re IDSA guidelines
More hydroxychloroquine: MedRxiv: Retrospective on US VA 368 patients
Is Coronavirus on my hair? My shoes? My newspaper? A reassuring read from the New York Times for family, friends, and all of us!
For Runners, Is 15 Feet the New 6 Feet for Social Distancing? Another less reassuring but hopefully still helpful NYT article.
Listeners will hone their skills in critical appraisal as they update themselves on all things COVID-19
After listening to this episode listeners will…
The Curbsiders report no relevant financial disclosures.
Ganatra R, Chiu CJ, Okamoto E, Roberts SP, Watto MF. “COVID Cakes: Remdesivir, anticoagulation, and presymptomatic transmission”. The Curbsiders Internal Medicine Podcast. http://thecurbsiders.com/episode-list April 29, 2020.
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Comments
I was somewhat disappointed in the ending of this episode. There was an amazing amount of discussion on research and what constitutes quality that we should follow as clinicians until the end when the discussion changed to running with a mask on. The study referenced in this section was a computer simulation that does not take into account additional wind patterns or viral inoculation requirements outside. We need to continue to focus on promoting heathy strategies. Having to wear a mask to exercise would be the one thing that keeps someone from making the choice to go outside and make changes that benefit their long term health.
The biggest bias is Gilead being involved in the study. In my opinion It makes the study very biased. Multiple studies have showed clinical outcome bias with pharm Sponsorship involvement.