Covid-19 roundup: RECOVERY trial halts recruitment for colchicine study after finding ‘no convincing evidence’; Italy blocks AstraZeneca vaccine shipment meant for Australia
It may be the end of the road for colchicine, an inexpensive oral anti-inflammatory drug commonly used to treat gout, as a potential Covid-19 treatment — at least in hospitalized patients.
The UK’s RECOVERY trial put out the word on Friday that it’s halting enrollment in its colchicine study after a data monitoring committee saw “no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any pre-specified subgroup.”
In a preliminary analysis of 11,162 patients randomized to receive either colchicine or standard care alone, there was no significant difference in the primary endpoint of 28-day mortality, according to researchers. The mortality rate was 20% in the colchicine group versus 19% in the usual care group. The final results will be published “as soon as possible,” according to a statement.
The RECOVERY trial was established to test a range of potential treatments for Covid-19. Recruitment to all the other treatment arms — including aspirin, baricitinib, Regeneron’s antibody cocktail, and (in selected hospitals) dimethyl fumarate — will go forth as planned.
“We do large randomised trials to establish whether a drug that seems promising in theory has real benefits for patients in practice,” Oxford University and joint chief investigator Martin Landray said in a statement. “Unfortunately, colchicine is not one of those.”
RECOVERY trial update:
— Martin Landray (@MartinLandray) March 5, 2021
The news comes just over a month after Montreal researchers read out some controversial data on colchicine’s effect as a Covid-19 treatment. While that study also failed its primary endpoint, researchers said the drug “reduces the composite rate of death or hospitalization” in non-hospitalized patients.
Out of 2,235 patients in the colchicine group, 104 had been hospitalized or died; among 2,253 in the placebo cohort, 131 reported those events. That translates to a 4.7% event rate versus 5.8% on the primary endpoint — or an odds ratio of 0.79 — with a p-value of 0.08. Five patients died in the colchicine arm, versus nine in the placebo group. On the secondary endpoint, 11 patients taking colchicine required mechanical ventilation while 21 who were given placebo did.
But if you look only at the 4,159 patients with PCR-confirmed Covid-19, investigators wrote, the difference widens slightly to 4.6% versus 6.0% and the 0.75 odds ratio becomes statistically significant (p=0.04).
Landray commented that it was a “travesty” that investigators in the trial had stopped enrollment with only 75% of patients, adding that it resulted in inconclusive results and uncertainty. — Nicole DeFeudis
Italy blocks AstraZeneca vaccine shipment meant for Australia
The AstraZeneca/Oxford vaccine rollout has run into yet another speed bump.
As the British drugmaker prepped a vaccine shipment for Australia of about 250,000 doses, Italy decided to prevent the delivery from leaving its borders, per a Financial Times report. It’s the first such intervention in vaccine exports since the European Union introduced new rules governing such shipments outside the bloc in late January.
Per the FT report, the EU had the power to object to Italy’s move and block their effort, but did not do so. And early Friday morning, France backed Italy’s plan to stop the shipment headed to Australia.
The controversial export plan was put into place by the EU in the wake of AstraZeneca saying it wouldn’t be able to provide the amount of doses pledged in its contracts a little over a month ago. Their hope is to force companies to disclose export plans, the FT cited European officials as saying, as the bloc seeks to reassert control of doses manufactured inside its borders.
Several countries had been exempted from the plan, allowing for AstraZeneca shots to be able to flow to poorer nations and those without their own production capabilities. EU officials drew harsh criticism, however, after including the UK on the exemption list despite leaving off other industrialized nations like the US and Japan.
Friday’s developments follow a rocky road for the AstraZeneca/Oxford vaccine. Though Britain and the EU have authorized the shot for use, there has been slow uptake around the world as the drugmaker and the bloc fought publicly over the doses the company would provide. And some people in European countries are reportedly shunning the vaccine in favor of mRNA-based shots with higher topline efficacy levels. — Max Gelman
Germany allows use of AstraZeneca’s vaccine in seniors — report
Days after Canadian officials said AstraZeneca’s Covid-19 vaccine should not be used on seniors, Germany has reversed its decision to restrict the jab from those 65 and older.
The German Health Ministry’s Permanent Vaccine Commission OK’d the vaccine for use on seniors on Thursday, and announced it would update guidance to incorporate a new recommendation that doses be spaced 12 weeks apart, BBC reported.
Health Minister Jens Spahn called the decision “good news for older people who are waiting for an injection,” per BBC.
The move was based on new evidence that AstraZeneca and Oxford University presented last month, which they said proves their vaccine is more effective when administered over the course of 12 weeks. The new regimen has already been approved by the UK.
Investigators wrote in a Lancet study:
In our study, vaccine efficacy was higher, after the second dose, in those with a longer prime-boost interval, reaching 82.4% in those with a dosing interval of 12 weeks or more. Point estimates of efficacy were lower with shorter dosing intervals, though it should be noted that there is some uncertainty as confidence intervals overlap. Higher binding and neutralising antibody titres were observed in sera at the longer prime-boost interval, suggesting that, assuming there is a relationship between the humoral immune response and efficacy, these may be true findings and not artefacts of the data.
Back in January, an expert panel in Germany recommended against giving AstraZeneca’s vaccine to those over the age of 65, citing “insufficient data available to assess the vaccine efficacy.”
While a Canadian panel of vaccine experts said earlier this week that vaccines from Pfizer/BioNTech and Moderna are preferred for those over 65, France also decided Monday to allow the vaccine’s use in seniors. — Nicole DeFeudis
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