Covid-19 roundup: Counting 1,087 trials for coronavirus, R&D experts say much of it is a complete waste; WHO scientist portends it will be 'years' before Covid-19 threat will be contained
There are good examples of R&D programs for Covid-19 drugs and vaccines, such as CEPI’s plan to advance a slate of new programs. But if you pull back and look at a landscape of more than 1,000 clinical trials now underway trying to make a mark, the field is a mess.
That, in blunt translation, is the point of a new op-ed piece in the BMJ penned by Paul Glasziou, director of the Institute for Evidence Based Healthcare, and colleagues.
Titling their piece “Waste in covid-19 research,” the team notes:
Before the pandemic, it was estimated that up to 85% of research was wasted because of poor questions, poor study design, inefficiency of regulation and conduct, and non or poor reporting of results. Many of these problems are amplified in covid-19 research, with time pressures and inadequate research infrastructure contributing.
The authors counted 1,087 clinical trials for Covid-19 interventions on clinicaltrials.gov, “and though some will provide useful information, many are too small and poorly designed to be helpful, merely adding to the covid-19 noise. Of the 145 registered trials of hydroxychloroquine, for example, 32 have a planned sample size of ≤100, 10 have no control group, and 12 are comparative but non-randomised. Outcome measures vary widely, and only 50 seem to be multicentre. Strikingly, only one provides a protocol, and even limited registry details reveal unjustified outcome switching.”
One of the other problems with the frantic rush into Covid-19, they add, is that non-drug interventions, such as the use of masks in preventing the spread of the virus, are being ignored. — John Carroll
WHO scientist portends it will be ‘years’ before Covid-19 threat will be contained
Painting a grim picture at the Financial Times’ Global Boardroom digital conference, the World Health Organization’s chief scientist predicted it will take some four to five years before Covid-19 is controlled.
Apart from therapeutics, there is a feverish effort to develop a vaccine globally, with some scientists hoping to have an early taste of data by the end of this year or early 2020. Pretty much all researchers agree that a safe and effective vaccine is the only way out of the crisis, but production and equitable distribution hurdles remain.
On Wednesday, the WHO’s Soumya Swaminathan indicated a myriad of factors would determine how long the threat of the coronavirus will remain in play, including whether it mutates, the containment measures imposed and whether a vaccine is developed.
Peter Piot, professor of global health at the London School of Hygiene and Tropical Medicine who was also speaking on the FT panel and is himself recovering from the viral infection, said countries should be thinking about the situation in terms of years, not months, and find ways to change the paradigm from lockdowns to more “granular, targeted types of interventions,” according to the FT report.
He also stressed the importance of testing, in line with the WHO’s recommendations. There is “no option but to invest more in testing,” Piot said. — Natalie Grover
Swiss drugmaker Novartis thinks a realistic vaccine timeline is “one and a half to two years”
Vaccines are hard to make. On average, in the pre-pandemic era, a decade was a reasonable timeframe to develop a vaccine, although some viruses such as HIV have proved elusive so far to the scientific toolbox. The record for the fastest-ever vaccine is for Ebola, which ravaged Western Africa between 2014 and 2016 — and that timeline is five years.
But the global impact of Covid-19 has triggered a gargantuan effort from scientists the world over, with some researchers promising their first batch of solid data by the end of this year — for example, the group at Oxford hopes to have viable data by the fall.
Vas Narasimhan, chief of Novartis — a company that is not developing a vaccine — said that a vaccine will likely only be available in “one and a half to two years” in line with a cautiously optimistic view of the pharmaceutical industry, Bloomberg reported, citing an opinion piece published by the CEO in a Swiss publication.
While health regulatory bodies in Europe and the United States have generally agreed to weaken the evidentiary standards for early vaccine studies given the expanse of the coronavirus crisis, scientists and experts have preached caution against these ambitious timelines.
Bill Gates, who was elected to pour substantial resources as part of his foundation to fight Covid-19, has said it could take between 9 months to two years to deliver a vaccine. The vaccine partnership between Oxford, AstraZeneca and Vaccitech — which aims to make 100 million doses by the end of 2020 — includes provisions to distribute the vaccine to low and medium-income countries, although the details are sparse. President Donald Trump’s recently-announced “Operation Warp Speed,” seeks to produce 300 million immunizations by the end of this year. — Natalie Grover
France’s Abivax kicks off big Covid-19 trial with drug that is engineered to have a three-pronged attack on Covid-19: antiviral, anti-inflammatory and tissue repair
With the French drugs and ethics agencies signing off on a 1,034-patient placebo-controlled phase IIb/III trial, called miR-AGE, of the company’s experimental drug, ABX464, Abivax is hoping the drug will help prevent severe inflammation that leads to acute respiratory distress syndrome in elderly or high-risk patients suffering from Covid-19.
The Parisian biotech’s oral therapy, which is also being evaluated as a treatment for ulcerative colitis, has been shown to upregulate miR-124, a “physiological brake” of inflammation, as well as tamp down cytokines involved in the Covid-19 cytokine storm. Separately, in vivo data suggest ABX464 inhibits replication of SARS-CoV-2, the virus behind Covid-19, the company said.
“Unfortunately, no prophylactic or therapeutic treatment has shown much efficacy in any rigorous trial to treat the severe form of COVID-19; helping clinicians prevent respiratory distress and death in COVID-19 patients and limit longer-term pulmonary damage is of paramount necessity,” said Abivax chief Hartmut Ehrlich in a statement. “The robust, rigorous design of the miR-AGE ABX464 trial ensures we will draw valid scientific and medical conclusions …We already have ABX464 capsules in stock to treat app. 50,000 patients and could scale-up ABX464 manufacturing for over one million patients within months.”
Gilead’s antiviral remdesivir is the only drug that has been granted emergency use authorization in the United States (it is also under review at the EMA) on the basis of placebo-controlled clinical trial data. However, only the top-line numbers have been released; the detailed data are still to come. Meanwhile, distribution and access are fraught, with its maker donating its initial supply of doses for roughly 140,000 patients to the federal government, because there is no portal for hospitals to apply for access to the medicine or outlined criteria for how the drug will be distributed and to whom, causing consternation and despair for doctors and patients alike. — Natalie Grover
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