The National Institutes of Health is preparing to launch a “flurry” of large clinical trials to test new approaches to treating Covid-19, according to the agency’s director, hoping to expand what for now remains a limited arsenal of therapies to help people with the disease.
In an interview, NIH Director Francis Collins characterized the studies as “really well-powered, rigorously designed clinical trials.”
Among the trials, he said: studies of antiviral monoclonal antibodies to treat Covid-19 in both hospitalized patients and patients who can be treated at home; studies of drugs to quell overreaction of the immune system that the agency has picked from dozens of approved treatments; and studies of blood thinners in very sick Covid-19 patients to prevent problems caused by blood clots. Those treatment studies will be on top of the work that the NIH is also doing on vaccines, including the Covid-19 vaccine being developed by Moderna Therapeutics.
Currently, only two drugs have been shown to be effective in patients with the disease. In clinical trials, Gilead’s remdesivir reduced the time it took patients to recover; dexamethasone, a steroid, prolonged survival in the sickest patients in a study conducted in the U.K.
Collins, who has been at the NIH for 27 years before becoming director in 2009, said he has become “obsessed” with the agency’s efforts to test medicines as treatments for Covid-19. He compared the tense and urgent effort to test Covid-19 treatments and vaccines to his time running the Human Genome Project, when there was a heated competition to deliver results before a private-sector project. He said the current effort is far more important.
“Nobody was going to die if we didn’t get the genome project done on a certain day,” Collins said.
Roughly a hundred people across government, academia, and industry have been working to organize large, systematic trials as part of the NIH’s Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) effort. The goal of the public-private partnership is to develop a coordinated approach to prioritizing and speeding development of treatments and vaccines.
Researchers have registered with the U.S. government to begin more than 1,200 Covid-19 studies, according to a STAT analysis. But 38% were small — consisting of fewer than 100 patients. That disorganized effort is unlikely to deliver clear answers about what treatments work and what treatments don’t. Collins said that’s why ACTIV is important. “I think it has been just what was needed to keep us from going down a pathway of continued small studies and chaos about results,” Collins said.
The new trials will be part of that effort. Regeneron Pharmaceuticals, which is developing an anti-Covid-19 antibody cocktail and is participating in an NIH trial on using such antibodies for prevention, will not be included in the antibody treatment trial. But Collins said that other major drug makers would be included. The decision of whether to participate in the studies is entirely up to the manufacturers, and he said that he has no complaints when a company, such as Regeneron or, on vaccines, Pfizer, decides it can move faster on its own.
Collins also warned that the science around both treatments and vaccines is complicated and unpredictable, and requires doing lots of different things with the knowledge that some will fail. But the only solution, he said, is to run many studies in parallel.
Collins said the NIH has aimed not to duplicate efforts being undertaken elsewhere, which is why the U.S. studied remdesivir but not dexamethasone. However, the NIH, the U.K., and the World Health Organization all conducted their own randomized studies of hydroxychloroquine in hospitalized patients; all were negative.
Regardless, Collins promised that the government is going to make sure that trials are conducted rigorously “so that you’re not wasting time, money, or people’s willingness to volunteer.” And he promised that despite the need for speed in vaccine development, there would be no cutting corners.
“We will not put something out, and FDA won’t let us, that is not safe and effective. That’s the bottom line,” Collins said. “Even if we come up empty, I will not tolerate the idea that you put something out that’s actually harmful.”
The NIH is also trying to fix another problem: the need for better, faster Covid-19 tests, through a $1.5 billion effort called the Rapid Acceleration of Diagnostics or RADx initiative,which Collins and his colleagues described in an editorial in the New England Journal of Medicine on Wednesday.
Current testing technology based on the polymerase chain reaction “doesn’t seem to work very well in terms of handling the demand when the demand starts going up higher and higher,” Collins said. RADx has settled on a “Shark Tank”-like format where small startups audition technologies to receive NIH support. Applications have come from 600 efforts, of which 27 have entered the shark tank stage; one is getting ready to begin efforts aimed at manufacturing scale up and clinical validation. Most of these efforts, Collins said, are point-of-care tests.
The goal, he said, is to have an impact soon. Said Collins: “We’re not going to invest in any test that can’t be scaled up to sufficient numbers to have an impact in the coming months.”
If specific vaccines are delayed, or proven not to be durable, effective or safe, low cost and scalable alternatives exists: nitric oxide delivered as a prodrug via oral administration is one such consideration. Inhaled nitric oxide (in clinical) and transdermal nitric oxide and immunologically boosted nitric oxide via non-specific immunity, ie, BCG (trials underway) have merit as well. Nitric oxide will likely be proven to lower viral burden and restore endothelial function…
… it’s unfortunate that HHS BARDA is so wedded to vaccines and remdesivir with little, if any consideration, of low cost, scalable alternatives.
How can I cure thee? Let me count the ways.
Commentary by Thomas E. Levy, MD, JD
He is a Cardiologist as well.
So it’s no promises if going to work r not
I am surprised you fail to mention leronlimab, a monoclonal antibody that recently completed a Phase 2 clinical trial for mild to moderate Covid patients, and is mid-way through a Phase 3 registrational trial for severe to critical Covid patients.
In that leronlimab has been used effectively, and with no serious adverse events, in 700 HIV patients, and has been used to treat over 65 Covid patients on an emergency use basis, with excellent results, this should be the one drug that is focused upon by commentators, the administration, and the FDA.
I want to know if the other medications can be used on any particular patient? The doctor has used remdesivir and the antibody but, not the other medication. I need to know if this is available in the USA.
My brother is fighting for his life and I refuse to give up on him. I need any trial to help him
If the US would look at what is already in advanced trials in the rest of the world, then it would not waste time re-inventing the wheel for a “made in America” solution. Which will be chosen based on hugely increased Pharma lobby moneys, thus eliminating the bright small fast innovators that could produce far better treatments. In the US, money speaks way too loud.
SV Findings in COVID-19 patients
Structural variations analysis was conducted using whole genome optical mapping approach (Bionano, Inc). Different classes of SVs were interrogated in a systematic approach and compared to the reference genome and also compared against the frequency of those SVs in the control database. A two-fold analysis was performed on COVID-19 positive samples. First, all variants were studied for patterns and impact. Second, a focused invesigation was performed on all COVID-19 related genes from literature. Our study revealed that severely ill patients had the following SVs in key genes implicated in immune response to virus/ SARS-CoV-2 infection.
How dare you state “Currently, only two drugs have been shown to be effective in patients with the disease.” ?? Incredibly incorrect. There are far more Covid treatments in advanced trial stages : nitric oxide (inhaled), a combi of 3 antivirals (interferon beta1, lopinavir, ribavarin, the last 2 already approved as combi for HIV since 2000), another combi of 3 antivirals (famciclivir, dipyridamole, mehtylprednisolone), acalabrutinib (already approved in US for blood cancers), colchicine (old safe cheap in multiple US trials), sofosbuvir + daclatasavir (in Iran), itolizumab (safety proven in lupus and asthma trials), favipavir (in Japan), budesonide (inhaled cortico-steroid) in phase 3 trial in different combinations with LAMA glycopyrollate and/or LABA formoterol. And that’s just the tip of the iceberg. Do your homework, Matthew !!
1 years worth of vitamin D for 2 adults is less than USD 40 on iherb, vitacost of lucky vitamins.
Vitamin D and covid is over and basic preventation for so much more. measure the vitamin D levels of people in old age homes and see below and you know why they died. A proefssor of medicene in Australia sent 60 pages on Vitamin D as preventative to hundreds of politicians in march and it was ignored,. Now we know he was right Vit D levels up and we are Ok.
Please read this and let it sink in.
Mainstream medicine is obsessed with drugs and vaccines and forgotten vitamin and nutrient level and frankly basic nutrition. No wonder the USA spends 17.7 of GDP on health and has got such a poor result, Australia and the UK spend 9% and live 3-5 years longer. The USA and much of the western world has our regulators and the industry far too intertwined and corrupted.
Thank you for this article. While a safe, tested vaccine or treatment drug available, we need to endure the virus. So, it is imeperative that we get ‘Rapid, Point of care Testing’ available.
Do you have any insight into this so called “15 sec rapid test with both finger prick or saliva” by an Austin based diabetes test company ? It appeared in NY news channel https://newyork.cbslocal.com/2020/05/05/coronavirus-covid-19-decision-diagnostics-testing/
According to them, it works by taking a finger-prick drop of blood and through sophisticated micro-processing, and arrives at a result within 30 to 45 seconds. The device costs $15 and the test strip kit costs $30. This could change the world.
I am baffled that at this point in time, having to wait many hours to take the test & then 2-8 days for the test result to come back due to volume!
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