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.”

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 

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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