“Game-changing” antibody cocktail prevents COVID-19 in the chronically ill

New Atlas ^ | August 22, 2021 | Rich Haridy

[Boomer]

A new monoclonal antibody treatment has been found to protect chronically ill adults from developing COVID-19. The Phase 3 trial results suggest the novel antibody cocktail, delivered by intramuscular injection, could offer up to 12 months protection.

[Boomer]

I don't know if this is the same antibody vaxx we've been talking about in other threads. Maybe someone can clarify. What strikes me is this is for those who are in the high risk category. Well; why not use it for everyone then if it's safe, proven, and tested long term? Kick the experimental unproven untested mRNA vaccines to the curb.

[Robert A Cook PE]

Might have zinc, eh?

[Gene Eric]

Even if acceptable, we still have the problem of passports, badges, etc

[Pollard]

Phase 3 trial results suggest

Yay, more brand new drugs. Who's going first?

[skimbell]

If this works it's going to cost at least $10K a shot, or it will wind up where ever all of those 300-500 mpg carburetors go.

[nuconvert]

This is not the same. It’s new

[AndyJackson]

Ban this. We need everyone to get vaxxed. EVERYONE!

[nuconvert]

The monoclonal antibody treatment now is only for early onset, in the 1st 10 days of symptoms, and only gives about a month of protection and is an infusion not an injection. This is my understanding I’m not an MD.

[King_Corey]

HCQ
Ivermectin
Zinc
Vitamin D
Chicken Noodle Soup
Sunlight
Fresh Air
Chlorinated swimming pool
Drink Water
Rest and relax

[ProtectOurFreedom]

Let's go to the source, the AZ press release on August 20 (below). Some key points:

• AZD7442 is a combination of two long-acting antibodies (LAAB; tixagevimab [AZD8895] and cilgavimab [AZD1061])
• It is derived from B-cells donated by convalescent patients after SARS-CoV-2 virus
• It reduced the risk of developing symptomatic COVID-19 by 77%
• >75% of trial participants had co-morbidities
• Single dose administered via two intra-muscular injections. Good news that you don't need an infusion.
• It is designed to minimise the risk of antibody-dependent enhancement of disease
• Development sponsored by the U.S. Government. Interestingly, the CDC and Fauci's organization are NOT on the list of USG sponsors.

Here are the guts of the press release:

Positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial showed AstraZeneca's AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial's primary endpoint.

AZD7442, a combination of two long-acting antibodies (LAAB; tixagevimab [AZD8895] and cilgavimab [AZD1061] - derived from B-cells donated by convalescent patients after SARS-CoV-2 virus), reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90), compared to placebo. The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.

There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. In the placebo arm, there were three cases of severe COVID-19, which included two deaths.

AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial.

The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The primary analysis was based on 5,172 participants who did not have SARS-CoV-2 infection at baseline.

More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination.

The LAAB was well tolerated and preliminary analyses show adverse events were balanced between the placebo and AZD7442 groups.

AZD7442 was optimised using AstraZeneca’s proprietary YTE half-life extension technology, which could afford up to 12 months of protection from COVID-19, and is delivered by intramuscular injection.

Preliminary ‘in vitro’ findings from investigators at Oxford University and Columbia University demonstrate that AZD7442 neutralises recent emergent SARS-CoV-2 viral variants, including the Delta variant.

AstraZeneca will prepare regulatory submission of the prophylaxis (PROVENT and STORM CHASER) data to health authorities for potential emergency use authorisation or conditional approval of AZD7442. Full results from PROVENT will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting.

PROVENT is a Phase III, randomised, double-blind, placebo-controlled, multi-centre trial assessing the safety and efficacy of a single 300mg dose of AZD7442 compared to placebo for the prevention of COVID-19. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium. 5,197 participants were randomised in a 2:1 ratio to receive a single intramuscular (IM) dose of either 300mg of AZD7442 (n = 3460) or saline placebo (n = 1,737), administered in two separate, sequential IM injections.

Approximately 43% of participants were 60 years and over. In addition, more than 75% had baseline co-morbidities and other characteristics that are associated with an increased risk for severe COVID-19 should they become infected, including those with immunosuppressive disease or taking immunosuppressive medications, diabetes, severe obesity or cardiac disease, chronic obstructive pulmonary disease, chronic kidney and chronic liver disease. Approximately 73% were White/Caucasian, 17% Black/African American, and 3% Asian. Approximately 15% of participants were Hispanic.

AZD7442 is derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. The half-life extension more than triples the durability of its action compared to conventional antibodies and could afford up to 12 months of protection from COVID-19 following a single administration. The reduced Fc receptor binding aims to minimise the risk of antibody-dependent enhancement of disease - a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.

AZD7442 is being studied in a comprehensive clinical trial programme for both prevention and treatment of COVID-19 in over 9,000 participants. Ongoing trials include TACKLE COVID-1913, a Phase III treatment trial in an outpatient setting and collaborator treatment trials in outpatient and hospitalised settings. AZD7442 is being assessed in both IM and intravenous administration routes.

AZD7442 is being developed with support from the US Government, including federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.

[laplata]

“HCQ
Ivermectin
Zinc
Vitamin D
Chicken Noodle Soup
Sunlight
Fresh Air
Chlorinated swimming pool
Drink Water
Rest and relax”

Hey, you’re using reason, common sense and logic. That’s not allowed.

[ProtectOurFreedom]

You got most of it wrong. See Post #11.

[nuconvert]

I don’t see anything I got wrong. Explain

[nuconvert]

Your post #11 is about this trial injection. My post was on the currently used infusion

[ProtectOurFreedom]

Ah, sorry about that. I didn’t see the word “now” in your post.

Yes, the current MAB is for after exposure. This new one is for pre-exposure prophylaxis.

BTW, the current MAB can definitely be administered via injection, not just infusion. There are restrictions on who can get it via injection, though.

[sauropod]

Bk

[Sergio]

bkmk

[sitetest]

“Preliminary ‘in vitro’ findings from investigators at Oxford University and Columbia University demonstrate that AZD7442 neutralises recent emergent SARS-CoV-2 viral variants, including the Delta variant.”

Probably because it’s using antibodies that developed after exposure to the whole virus, so the antibodies “remember” more details about the virus than just the spike.

[corkoman]

"Long-acting" antibodies? Or is it that the IM injection releases the antibodies over a sustained period of time.

I have a feeling its the latter. But just how much material can you inject into a muscle for 12 months of effective treatment? Is there a golf ball sized lump on your glute??