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The big National Institutes of Health (NIH) effort on long COVID is rolling. It hasn’t come easily or quickly and the NIH has a lot of catching up to do. The world has known long COVID is a serious problem since last summer, but you wouldn’t have known it by the NIH. If it weren’t for NIH Director Francis Collins’s blogs on long COVID, and one workshop, one would have wondered if the NIH even knew long COVID existed.

funding long COVID

Congress gave the NIH $1.15 billion dollars to understand and find a cure for long COVID. Now the NIH has to make good on that investment.

No program announcements or grant efforts were created. The only thing I’ve been able to find that the NIH did was to allow add-ons for previous grant applications. A recent search on NIH’s Project Reporter site over a year after it was clear that long COVID was a real and serious condition, uncovered precious few NIH-funded long- COVID grants. For those in the chronic fatigue syndrome (ME/CFS) community, it seemed like a bad case of déjà vu. The NIH was once again ignoring a mysterious but often disabling post-infectious disease.

Then in jumped Congress. If the NIH wasn’t going to lift a finger to help long-COVID patients, Congress would, and at the end of December, President Trump signed a bill that gave the NIH a whopping $1.15 billion dollars to study long COVID over four years.

Now the NIH is on the hook for answers. You don’t provide that kind of change without an expectation that answers will be coming – and as quickly as possible. The NIH, though, is facing enormous challenges – challenges it itself helped to create. It’s dealing with a new disease entity in a field (post-infectious disorders) it’s almost completely ignored. It certainly had the opportunity to explore the field with chronic fatigue syndrome (ME/CFS) – the poster child for infectious diseases.

ME/CFS, with its high rates of disability and its horrifying impacts on functioning – significantly worse than found in heart disease, heart attack, diabetes, and multiple sclerosis – provided ample warning that a pandemic would likely leave hordes of significantly impaired people in its wake.

Given that, it was kind of hilarious to hear NIAID Director Anthony Fauci say that the idea of a pandemic kept him up at night, as he failed to provide even pitiful amounts of funding for the 1-2/12 million people with ME/CFS.

NIH head in sand

Decades neglecting post-infectious illnesses meant the NIH was almost completely unprepared for the advent of long COVID.

Those decades of neglect meant the NIH doesn’t have set protocols, a deep knowledge base, or a large bench of researchers or doctors to draw on as it tries to tackle long COVID. Virtually everyone the NIH funds will in some way be new to this game. Learning on the fly is not a great way to carry out a project like this.

Now that Congress had given the NIH funding, though, it appears to have fully embraced its mission. It could have chosen to open its coffers to all sorts of grant applications – resulting in the chaos we often see in medical research. Instead, in his February blog, “NIH launches new initiative to study Long COVID”, NIH Director Francis Collins indicated the NIH was taking a highly, organized, methodical approach to long COVID.

The groundwork for that approach was laid with three enormous infrastructure grants (48 million dollars – New York University of Medicine; $46 million – Mass General Hospital, $40 million – Mayo Clinic) that were announced in spring/summer. That meant the NIH spent almost $140 million – 12% of its total long-COVID funding – to develop the core infrastructure (Science Core, Data Resource Core, Biorepository Core, Interactive Data Portals / Robust Analytic Tools) for the massive effort.

The NIH provided short-term grants in May and June to no less than 30 institutions simply to develop the master protocols for the studies. The standardized trial designs and research methods that resulted, though, will allow researchers to speak the same language, enabling them to quickly glean insights from the studies underway. The harmonized data will go into large databases that will provide the meat for large analytical studies.

NIH Recover Infrastructure

The NIH has quickly marshalled an impressive, organized effort to understand long COVID

Patient samples of all sorts of tissues will go into a central biorepository. Wearables, smartphone apps, electronic health records, and telehealth will take advantage of digital-age technologies. Large, long-running cohorts such as the Framingham study that will be integrated into the study, will help researchers understand who gets long COVID and how it’s affecting them. These studies are particularly valuable because they will be able to provide long-COVID biological data – making it easier to see how having long COVID has changed a person’s biology.

Thirty to forty thousand people will be followed long term. Hundreds of clinical research sites should be announced soon. Other post-infectious cohorts including ME/CFS, and healthy controls, will serve as control groups. Correction – Apparently the NIH will not be including people with ME/CFS in its initial grant package. The NIH specifically mentioned ME/CFS in its grant information and prominently featured the below statement featuring ME/CFS on the FAQ section of the RecoverCOVID website.

“… may also help improve our understanding of other post-viral syndromes, such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and autoimmune diseases—conditions in which the body’s immune system attacks healthy cells.”

It took nine months after NIH knew it was getting funds for the NIH to announce what its major effort entailed. Was this the NIH lagging behind on long COVID? Not at all.

This is actually what the NIH on speed looks like. The NIH typically takes six to eight months to create a grant package. This time it created the long-COVID infrastructure package in two months. It usually takes months and months to review the grant applications it gets. The NIH reported though, it’s already awarded $500 million in grant awards – almost half the money provided by Congress – to over 100 researchers at more than 30 institutions. The NIH is actually moving with blazing speed. Director Collins said it would ordinarily take the NIH 2-4 years to produce something like this.

Urgent Request for Long-COVID Clinical Trials

In August, the NIH did something remarkable. It created an “Urgent” request for long-COVID clinical trial applications. This request, perhaps more than anything, demonstrates how the NIH is casting aside old behaviors as it attempts to quickly deal with long COVID

The NIH states that it will not fund clinical trials for ME/CFS because it doesn’t believe an evidence base exists that could produce positive results. Dr. Koroshetz has warned that moving too fast into clinical trials could doom later trials for ME/CFS if the early trials didn’t work out. The NIH believes the science needs to be built up first.

Even before we know anything substantive about long COVID, the NIH has put out an “urgent” call for clinical trials.

That’s clearly not the stance it’s taking with long COVID. The NIH is urgently asking for clinical trial applications long before we know anything substantive about the disease. The Request, “Urgent Request for Applications (RFA) to Repurpose Existing Drugs to Treat Long COVID”, stated: “There is an urgent public health need to find therapies to ameliorate COVID-19 disease sequelae”. The RFA will support Phase I or II clinical trials with this effort and is particularly looking for “novel” treatments.

The NIH Is willing to plow through quite a few failed trials and spend quite a bit of money, to find a few things that work. That’s completely contrary to how the NIH usually works but it’s apparently what happens when Congress hands over a billion dollars and says figure this thing out. Given the overlap we’ve seen between long COVID and ME/CFS, it would be surprising, indeed, if some of those clinical trials didn’t open opportunities for people with ME/CFS as well.

Enormous Challenge – Enormous Opportunity

While the challenges are enormous, so is the opportunity. The NIH has been given funds to bring all its resources, all its talent, and all its organizational and technological expertise to bear on a brand-new disease entity. This is its chance to show what it can do. If it works out, I imagine this effort will set the template for future others.

It’s taken 9 months to get to this point, but Collins doesn’t expect it will take years to glean important insights into long COVID – he expects they will begin showing up in the “coming months”.

“… these studies are expected to provide insights over the coming months into many important questions including the incidence and prevalence of long-term effects from SARS-CoV-2 infection, the range of symptoms, underlying causes, risk factors, outcomes, and potential strategies for treatment and prevention.”

Time will tell how this highly organized and quite impressive approach will fare. We won’t know who has been funded, what the studies are assessing, or whether ME/CFS or other post-infectious disease cohorts will be involved until the grant data has been released.

With 100 researchers funded thus far to the tune of some $250 million, it appears that the NIH has been focused on funding large studies that are running into the tens of millions of dollars. If that’s right, that kind of large study probably cuts out just about every ME/CFS researcher in the book – potentially leaving a lot of knowledge and expertise on how to understand and work with post-infectious diseases on the table. With about $650 million left, the NIH still has plenty of money to engage smaller research efforts in the fight.

The NIH may be the biggest medical funder in the world, but it’s certainly not the only one. Long-COVID studies are starting to pour in from countries across the globe. Those studies will be the subject of an upcoming blog.

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