A press release from Enlivex reports positive top-line results from phase II clinical trial evaluating its drug Allocetra in severe and critical COVID-19 patients.
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“This is possibly a promising drug for treatment of very severely ill patients with Covid-19 (and other diseases for which it has been intended). It is possibly useful at the same stage of disease as that in which patients treated with dexamethasone has shown to be effective in large randomised controlled trials.
“The results here are not from a randomised or controlled trial and is effectively an observational study. Even though the results look encouraging with no patients dying out of 16 treated in the Phase 2 study, the results are statistically compatible with a mortality rate of over 20%.
“These results should therefore be treated with great caution, and it would be good to see properly randomised controlled trials comparing this, as yet unlicensed, drug with the cheap and easily available proven effective treatment of dexamethasone in similar patients.”
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Prof Stephen Evans: “No conflicts of interest. I am funded (one day per week) by LSHTM. They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them. I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI. I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs. I am a participant in the Oxford/Astra Zeneca trial, and on 13th January 2021 learnt I had received the active vaccine.”