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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