Some additional comments on the design of the study conducted by the University of Kentucky

While we are cur­rent­ly work­ing on oth­er urgent mat­ters and have hard­ly any time to fol­low up on the the throat dis­in­fec­tion com­plex, let us – very briefly – make the fol­low­ing addi­tion­al com­ments with regard to the study under­way in Kentucky. If noth­ing else, they may serve as a men­tal check to the study inves­ti­ga­tors (who we will make aware of them, of course).

  1. The pri­ma­ry end­point of the study appears to be to not “test pos­i­tive for COVID-19”. Since the study design­ers them­selves acknowl­edge that “up to 50% of infect­ed patients may be asymp­to­matic or with neg­li­gi­ble symp­to­ma­tol­ogy”,1 we reit­er­ate that one should dif­fer­en­ti­ate between a “SARS-CoV-2 infec­tion” on the one hand – which for about half of all infect­ed peo­ple is real­ly more or less “noth­ing” – and COVIDisease-19 on the oth­er, mean­ing that the infec­tion leads to severe symp­toms, pos­si­bly to pneu­mo­nia and in extreme cas­es to death. So we would again like to stress that the ques­tion is not so much one of avoid­ing an infec­tion alto­geth­er in 100 % of cas­es – while this would doubt­less be desir­able -, but to make sure that an infec­tion can eas­i­ly be man­aged and has lit­tle to no symp­to­matic con­se­quences, because the immune sys­tem – most­ly already the innate immune response – is aid­ed suf­fi­cient­ly in cop­ing with any virus “suc­cess­ful­ly” infect­ing (some) pha­ryn­geal cells. Logically, one end­point of the study, in addi­tion to not test­ing pos­i­tive, should be symptom/disease sever­i­ty. For if the pro­pos­al we have made ensures that many more, and hope­ful­ly essen­tial­ly all, infect­ed per­sons can join the ranks of the 50 % who remain asymp­to­matic in the first place, this would suf­fice to declare vic­to­ry over the pandemic.
  2. This is a phase 2 study, for which the inves­ti­ga­tors esti­mate to enroll about 250 sub­jects. As we under­stand it, these 250 sub­jects are divid­ed into health care work­ers and vol­un­teer patients, and then in both groups into a test and a con­trol arm. So not real­ly the large study that would be desir­able in the con­text of a pan­dem­ic of the scale of COVID-19, and not large enough to test for the end­point “dis­ease sever­i­ty” as out­lined under “1.” above.
  3. We have already men­tioned yes­ter­day that we find it regret­table that study par­tic­i­pants are not asked to employ throat anti­sep­sis also imme­di­ate­ly before going to sleep, for the rea­sons out­lined ear­li­er.2
  4. We are not sure about the log­ic of lim­it­ing health care work­ers’ par­tic­i­pa­tion in the study to a mere three weeks when the study is sched­uled to go on for a year. Results obtained would be much more mean­ing- and pow­er­ful if health care work­ers were to adhere to the pro­to­col for at least sev­er­al months and pos­si­bly the entire dura­tion of the study. One could then also seek to com­pare the rate of detect­ed SARS-CoV-2 infec­tions, as well as estab­lished dis­ease sever­i­ty, in patients with that of hos­pi­tals who do not par­tic­i­pate in the study. Once it becomes clear that the mea­sure is suc­cess­ful, since this is an open label study, one could imme­di­ate­ly pro­ceed to intro­duce nasopha­ryn­geal anti­sep­sis as a gen­er­al pro­tec­tive measure.
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  1. https://clinicaltrials.gov/ct2/show/record/NCT04364802[]
  2. https://loico.com/the-logic-of-surviving-the-coronavirus-pandemic/, https://loico.com/additional-thoughts-regarding-benefit-throat-disinfection-covid-19-like-epidemics/[]
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A group of researchers from the UK (Cardiff and Cambridge), the US (Denver, Colorado), Spain (Barcelona), and Canada (Ottawa) has now picked up the idea we have put forward almost exactly two months ago for preventive throat disinfection with virucidal agents that are known to be effective against coronaviruses and safe to use in the throat. The WHO should now even more seriously consider including it in its recommendations.
COVID-19, many believe, has thrown the world into unprecedented disaster, and to those believing so, the future looks bleak at best. But what if the opposite will prove to be true? Speculation is a noble occupation, futures studies an academic discipline, so we hazard a brief preview of the enormous economic and societal gains for which the COVID-19 crisis may have just sown the seeds.
While in recent weeks we have been focused on establishing and comprehending as deeply as possible the immunological “big picture” in viral epidemics from so far only partly interconnected evidence in the specialist literature, in order to derive actionable recommendations, we briefly summarize what has emerged in terms of feedback as well as additional insight with regard to our first article since it appeared.

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A group of researchers from the UK (Cardiff and Cambridge), the US (Denver, Colorado), Spain (Barcelona), and Canada (Ottawa) has now picked up the idea we have put forward almost exactly two months ago for preventive throat disinfection with virucidal agents that are known to be effective against coronaviruses and safe to use in the throat. The WHO should now even more seriously consider including it in its recommendations.
COVID-19, many believe, has thrown the world into unprecedented disaster, and to those believing so, the future looks bleak at best. But what if the opposite will prove to be true? Speculation is a noble occupation, futures studies an academic discipline, so we hazard a brief preview of the enormous economic and societal gains for which the COVID-19 crisis may have just sown the seeds.
While in recent weeks we have been focused on establishing and comprehending as deeply as possible the immunological “big picture” in viral epidemics from so far only partly interconnected evidence in the specialist literature, in order to derive actionable recommendations, we briefly summarize what has emerged in terms of feedback as well as additional insight with regard to our first article since it appeared.