Covid-19 roundup: NIH spotlights blood thinners in its next big trial; All it took was a pandemic to get JPM out of SF
After immune modulators and antibodies, blood thinners are the next class of drugs to be put through a Phase III trial organized under the NIH’s ACTIV initiative.
Three different anticoagulants have been named for the master protocol: heparin, aspirin and apixaban. Informed by studies suggesting that many patients who died from Covid-19 have formed unusual blood clots throughout their bodies — including in their smallest blood vessels — the NIH wants to see which therapies are the most effective at preventing or reducing them and thus improving outcomes for patients.
“There is currently no standard of care for anticoagulation in hospitalized COVID-19 patients, and there is a desperate need for clinical evidence to guide practice,” agency head Francis Collins said in a statement. “Conducting trials using multiple existing networks of research sites provides the scale and speed that will get us answers faster.”
For the inpatient trial, patients will be given either a low dose or a high dose of heparin.
But hospitalized patients are just one of two groups now being recruited to ACTIV-4, which also includes an outpatient trial — broken down into four cohorts given placebo, aspirin, or a low or therapeutic dose of the blood thinner apixaban. The goal there is to reduce life-threatening cardiovascular or pulmonary complications in newly-diagnosed Covid-19 patients who don’t need hospital admission.
Gary Gibbons, director of the National Heart, Lung, and Blood Institute, said while heparin has shown promise, physicians “really need clinical trial data to determine how much blood thinner, or even anti-platelet medication, to give.”
A third trial will start soon involving patients who had moderate or severe disease but have been discharged after hospitalization. It has a slightly different design, with the key metric being whether patients develop thrombotic complications (think heart attack, stroke, blood clots in major veins or arteries and death) within 45 days of being hospitalized.
As is custom in these master protocols, researchers may switch out candidates or add in new therapies as clinical data emerge.
NHLBI is coordinating and overseeing the program, while Operation Warp Speed is providing the funding. — Amber Tong
#JPM21 goes virtual
The JP Morgan Healthcare Conference just got a whole lot cheaper.
On Thursday, the bank told clients that the famed conference was going virtual. That means no more packing into ballrooms and conference halls, no more dashing between different hotel rooms for an endless circle of meetings, and crucially no more $2,000 suites and $150 rent-a-tables. Instead, there will only be what there has been for the last 6 months: Endless circles of Zoom meetings, looped in infinite recursion from San Diego to Boston to Cambridge, UK.
The virtual conference means that, after years of chatter, the conference will finally, at least for a year, leave San Francisco. In theory, though, you could still go. A room at the Westin is selling for only $276, breakfast not included. — Jason Mast
Would you take a vaccine before November 3?
Longtime FDA officials and drug companies are trying to shore up public confidence in an eventual Covid-19 vaccine, but a new poll suggests that, at least until the election, they could be facing an uphill battle.
The poll, conducted by the Kaiser Family Foundation, found that most adults, both Republican and Democrat, are wary of taking a vaccine before the election. Six in ten adults, meanwhile, were worried that the Trump Administration would pressure the FDA to rush an approval. The poll was conducted between August 28 and September 3 — days after a heavily politicized emergency use authorization for convalescent plasma stoked fears that a vaccine would be authorized under similar conditions.
Fear of political pressure was most acute among Democrats, 51% of whom said they were “very worried” and 85% of whom were at least “somewhat worried.” A majority of Republicans said they were “not too worried” or “not at all worried,” although 35% expressed some concern.
As to whether they would take a vaccine, though, the splits are reversed. Half of Democrats were willing to take a vaccine, but only 36% of Republicans said they would. These numbers are in line with long-running differences between Democrats and Republicans on vaccination, though it does suggest that recent events may have dented views. A Gallup poll conducted in late July and early August found 81% of Democrats and 47% of Republicans were willing to take an “an FDA-approved vaccine to prevent coronavirus/COVID-19” if it “was available right now at no cost.” Those questions, though, did not directly reference the election.
Still, most respondents did not think such an eventuality was likely. Eighty-one percent of people, regardless of party, did not expect a vaccine to come before November 3.
The polls come as officials in the US struggle to shore up confidence in any eventually approved vaccine. Earlier this week, 9 major drug companies signed a pledge to only submit vaccine data when it meets safety and efficacy standards and 8 FDA career officials published an open letter in USA Today on their commitment to science. Even before the latest concerns of political interference, public health experts have talked for months about how rising rates of vaccine hesitancy could pose a barrier in pandemic response. Bill Gates has called getting people to actually take a vaccine “the final hurdle.”
New data highlight how critical messaging can be on vaccine uptake. A large study published this morning in The Lancet tracked global vaccine hesitancy from 2015 to 2019 identified misinformation as one of the key factors in places with growing skepticism of vaccines, including South Korea, Malaysia, and Georgia. Anthropologist and director of the Vaccine Confidence Project Heidi Larson, the study’s author, said messaging in the US and elsewhere that focused on speed wasn’t helping.
“There’s a lot of anxiety about the speed of vaccine development (for COVID-19),” she told Reuters. “But the public is not really keen on speed – they’re more keen on thoroughness, effectiveness and safety.” — Jason Mast
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