RE: Home trial USA?16 Dec 2020 23:59
Noted Matterhorn, though remember that ethics applications and approvals are a moving feast. See SG016. Started out as an in-hospital P2 trial. That has reported in the Lancet but it is the vehicle that is doing the home testing patients still (as an add-on).
The main P3 ethics is granted without home trial with the following as three of the inclusion criteria
2. Admitted to hospital due to the severity of their COVID-19.
3. Positive virus test for SARS-CoV-2 using a validated molecular assay (e.g. RT-PCR). Patients who had positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test was performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection.
4. Require oxygen therapy via nasal prongs or mask (OSCI score of 4).
However it is plausible that that same vehicle (SG018) can morph to include other elements via the same ethics committee, should the FDA wish it to have a home-trial supported by Warp-Speed, if Synairgen wish to. Or they could start another P3 application. I think the latter is highly unlikely, the least number of RCTs set up the cheaper and faster it is. IMHO