Clinical Trials of Monoclonal antibodies A... - Leukaemia CARE

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Clinical Trials of Monoclonal antibodies AZD7442 against SARS=CoV-2 (COVID19) - majority of sites in UK and USA

Jm954
Jm954

There are two clinical trials of monoclonal antibodies that target covid19.

AstraZeneca is developing mAbs to the SARS-CoV-2 S protein. The SARS-CoV-2 spike protein contains the virus's RBD, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, is expected to block infection. Amino acid substitutions have been introduced into the antibodies to both extend their half-lives, which should prolong their potential prophylactic benefit and decrease Fc effector function in order to decrease the potential risk of antibody-dependent enhancement of disease.

Monoclonal antibodies are artificially produced in a laboratory and designed as possible medical treatments. They are designed to be injected directly into the body, unlike vaccines which ‘train’ the immune system itself to produce antibodies.

AZD7442 is a combination of 2 of these mAbs (AZD8895 and AZD1061) and is being evaluated for administration to prevent and/or treat COVID-19.

The first trial is called STORM CHASER - a Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults. This is two doses of antibody. STORM CHASER is exploring the use of a combination of monoclonal antibodies given intramuscularly in those who have been exposed to SARS-CoV-2 – a setting where vaccination would not have time to work and we have no other proven therapies to date. This makes STORM CHASER an important study that may have a large impact on our ability to control this infection.

The second is called PROVENT - a Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adults. This is a single dose of antibody and the trial is for people who may not respond to vaccination (for instance where someone has a compromised immune system) or are at increased risk of Covid-19 infection due to factors such as age and existing conditions. As licensed vaccines become available to qualifying trial participants, a mechanism will be put in place to enable them to safely leave the study if deemed medically beneficial. Being a trial participant in one of the studies will not delay the process of receiving a vaccination and should not prevent patients being involved in other studies if they do develop an illness related to Covid-19. Note that there is currently no provision to cross over if the MAB arm proves beneficial.

BOTH trials involve the use of placebo as the comparator arm with a 2:1 randomisation of AZD7442:saline placebo so you may not get the antibody. The trials are double blinded so not even your doctor or trial worker will know what you have received.

The vast majority of sites are in the USA but STORM CHASER has sites 6 UK sites with 1 London site (NW1 2BH) recruiting at the moment. Other UK sites include Southampton SO16 6YD; Wakefield WF1 5RH; Hull HU3 2KZ; and Manchester M8 5RB; and another London site EC1A 7BE.

PROVENT is also massively recruiting in USA but also France, Belgium, Spain as well as the 8 UK sites which include Enfield, EN1 1LJ; Hayle, TR27 5DT: London,WC1N 3BG; Preston, PR1 6YA; Rochdale, OL11 4AU; Southampton, SO16 6YD; Torpoint, PL11 2TB; Wakefield, WF1 4DG

More here: uclh.nhs.uk/news/uclh-doses...

STORMCHASER: clinicaltrials.gov/ct2/show...

PROVENT: clinicaltrials.gov/ct2/show...

Jackie

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HAIRBEAR_UK
HAIRBEAR_UKAdministrator

Thanks for the post Jackie. Interesting trial and roll of the dice.. The science is moving quickly.

2003UK
2003UKChampion

Thanks for the details of these clinical trials. Take care and stay safe.