Current SUPERNOVA Clinical Trial for Reformulated EVUSHELD for preventing COVID-19 infection for immune-impaired individuals

[Classicaljazz]

A Phase II sub-study of SUPERNOVA clinical trial (2023) is currently operating to test the efficacy and safety of AZD3152 as a component of a reformulated version of EVUSHELD mAbs prophylaxis for immune-impaired individuals who cannot mount antibody responses to COVID-19 vaccines.

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study (SUPERNOVA). (2023 December 18). Identifier NCT05648110. U.S. National Library of Medicine. clinicaltrials.gov/study/NC...

Some of the exclusion criteria are:

Receipt of IV or SC immunoglobulin within 6 months prior to Visit 1 or expected to receive IV and SC immunoglobulin 6 months after dosing.

Receipt of convalescent COVID-19 plasma treatment within 6 months prior to Visit 1.

Previous receipt of a mAb against SARS-CoV-2 within 6 months prior to Visit 1.

Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.

Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1.

COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at home testing])

[Eucalyptus22]

This trial has been ongoing in UK since spring/summer last year. Although the trial is not due to be completed until October this year I understand that the MHRA and NICE will be looking at the data early this year. It is interesting that the French authorities have approved Supernova under emergency licence already. One to watch!

[Mijoed]

The Supernova trial has been running for over six months now in the UK. I was one of the first to be dosed. Your comments for exclusion criteria , especially immunoglobulins, apply for the whole trial.

Initially they either gave AZD3152 or a double dose of the original Evusheld as placebo. Now, for the second dose, they have switched the placebo to water due to the ineffectiveness of original Evusheld against current versions of Covid.

I received my second dose back in December and performed an antibody test a few weeks later. Unfortunately it looks like I received the original Evusheld first time and water for the second. Antibodies after the first dose >2500 U/ml. Antibodies prior to the second dose 196 U/ml and 52 U/ml afterwards.

I took part in the Provent trial for two years during the pandemic and was able to get on with life as normal. Hopefully there won’t be long delays in approving the new drug.

[TerryGrigsby]

Beware of Evusheld. I had one dose in the spring of 2022…had a heart attack in Nov. 2022…Didn’t have cholesterol or plaque buildup, therefore no stent, but a blood clot to a major artery. My hematologist at Dana-Farber advised against getting the second dose. he is seeing people have heart issues with no issues before taking Evusheld.

[johnliston]

Came across this post this morning right before my routine appointment and labs for the Supernova trial that I've been on since last spring. I've already had both shots and I've been on IVIG the whole time. I brought this to their attention and they weren't sure what happened. They guessed that this restriction wasn't in place when I started the trial, but they really weren't sure. Nobody ever said anything to me about it and I didn't sign anything that said I was aware of this restriction. Anyway, they said if someone made a mistake they might have to exclude might data, but it shouldn't harm me. Makes you wonder who's running these trials.

john

[tesoro5858 in reply to johnliston]

Coincidentally, I also had received IVIG the month prior to my first injections on the Supernova trial. I did not hide this fact and do not recall if they asked me about IG. I have not been receiving IVIG during the trial, however. My second injection was in November so I am now 8+ months into the trial.