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).
- 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.
- 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.
- 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
- 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.