It's impossible to know the exact details of the trial without seeing the protocol, but we can guess.
Apparently will have 12 healthy cohorts, as you suggested:
1A - healthy controls, single dose, syrup or gummy, 3 dose levels = 6 cohorts, presumably 3 in each?
Observe for 2 days.
1B - healthy controls, multiple daily doses x 5 days, syrup or gummy, 3 dose levels = 6 cohorts, presumably 3 in each? Observe for 7 days?
Presumably this would be N=36 here for healthy controls.
Then also after that, will include N=36:
1B - mild to moderate Covid, NOT expected to require hospitalization within 48 hours. Have no idea if will dose these by syrup or gummies, and which dose level(s) they will use. Maybe they will do the same thing they did for healthy controls, with 12 cohorts of 3 each, starting with single dose of syrup or gummies at lowest dose, and working up dose levels, then also try multiple doses the same way?
It's interesting that they specify that Covid patients will be expected NOT to require hospitalization for clinical purposes within 2 days. Does that mean they will admit them 7 days of observation still, or treat them at home / as an outpatient and have them come back only if they get worse? Probably admit them only for the study, and they don't want people they will actually need to treat for Covid so quickly.
Why exclude kids and elderly? Probably because too much hassle for kids (usually get to them after it's proven safe in adults) and don't want more frail elderly (want to minimize possibility of bad outcomes if they are more frail to start).
So, playing it safe until they show safety, then can include kids, elderly, and sicker subjects.
Ha, yes, Diwan continues to be inappropriately overly promotional in just about everything he says!
But at least he is finally running a trial.
The trial results will help start to sort out the truth from the Diwan BS.
Theoretically, the nanoviricides are independent of the host and safe for all hosts. But of course that needs to be proven in large trials.
BTW, apparently Diwan is able to manufacture enough nanoviricide material in a consistent way that satisfies the Indian medical regulatory authorities. It seems like they will use ~300g of NV-CoV-2 for this trial (assuming average subject ~70 kg).
So I guess that is 2 mega-oft-repeated opinions that have been proven wrong so far?
We still don't know if nanoviricides are safe (but they seem to be so far at doses studied) or effective in humans. We also don't know how much will be required for each dose. For Covid, it could be 20 mg/kg/day * 70 kg * 5 days = 7 g per course. Can they manufacture a 5-10 g / dose course at a good profit margin? What is their production capacity?
