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Earlier today President Trump received a polyclonal antibody cocktail made by the company Regeneron. Here’s what we know about this drug, and the additional drugs a patient in his situation might receive in the coming days.
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The cocktail is a combo of 2 lab-generated antibodies. The goal here is to boost an individual’s immune system rather than waiting for the body’s response to kick in on its own. When given early in the course of infection, this can theoretically shorten the length of illness 2/n
No peer-reviewed studies have examined whether Regeneron’s cocktail is safe or effective. Just 3 days ago the company announced (but did not publish) preliminary data from its ongoing trial. 3/n https://investor.regeneron.com/news-releases/news-release-details/regenerons-regn-cov2-antibody-cocktail-reduced-viral-levels-and
The initial findings suggest that the drug reduced viral load in some patients, but there’s no evidence yet that it reduces severity of symptoms or mortality. More importantly, a press release alone should never form the basis of clinical decision-making. 4/n
Patient care is always about balancing potential risks & benefits. Any infusion of monoclonal antibodies is associated w/ possible adverse reactions, ranging from mild to life-threatening. In addition, this drug isn't FDA-approved, so its full safety profile is unknown. 5/n
Given potential risks & the President’s reportedly "mild" symptoms, the risk-benefit ratio here would ordinarily tilt away from an unproven drug. The fact that his physicians gave the drug & that Trump is now being moved to Walter Reed suggests we don't know the full picture 6/n
Once a patient is hospitalized, management of COVID changes somewhat compared to those who are well enough to remain at home. If the President requires supplemental oxygen at Walter Reed, most guidelines suggest starting remdesivir & dexamethasone. 7/n https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/
Unlike w/Regeneron's cocktail, we DO have data supporting these drugs (although not full FDA approval). A UK-based trial found low-dose dex reduced 28-day mortality compared w/ usual care among patients requiring oxygen. 8/n https://www.nejm.org/doi/full/10.1056/NEJMoa2021436
Another multinational trial of >1000 patients found that remdesivir was associated with faster time to recovery (median 11 vs 15 days w/placebo) in COVID patients with pulmonary involvement. 9/n https://www.nejm.org/doi/10.1056/NEJMoa2007764?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
Hopefully none of this is necessary, and the President has a swift recovery. But his use of Regeneron's drug will certainly focus attention on a company that, until this week, was only giving patients access if they enrolled in clinical trials. 10/n https://www.nytimes.com/2020/10/02/health/trump-antibody-treatment.html
Monoclonal antibodies hold promise for managing COVID-19. But they are expensive, difficult, and time-consuming to produce, and not without risks. Today's high-profile use shouldn’t obscure the reality that more studies are needed to determine which patients they can help. 11/11
