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Monoclonal Antibodies Enter Phase 3 Clinical Trials

At this time convalescent plasma is either a therapeutic "breakthrough" for Covid-19 or an unproven therapy to passively transfer antibodies from a recovered Covid-19 patient, because no randomized control trials were completed.  Thousands of patients have been given convalescent plasma and yet  Phase 3 randomized, placebo-controlled trials have not been done.  

Very specific monoclonal antibodies, which are directed against the spike protein of coronavirus, are now entering Phase 3 Clinical Trials, and hopefully these will be both effective, safe, and scientifically proven.    

Monoclonal Antibodies:

This technology was first developed in the 1970s and is now being used to create many types of therapy, including cancer "drugs".  In the classic method, cells from previously infected patients are fused with a antibody producing cells that are grown in cell cultures.  These cells become a protein factory which manufacture just one potent neutralizing antibody against the virus. They can then be infused into patients.

Several monoclonal antibody phase 3 trials were just started and everyone is hoping that these highly specific antibodies against SARS-CoV-2 will be able to prevent infection after a close contact.  Continue Reading: 

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One of the monoclonal antibodies is from Lilly-NIAID (NIH) and contains one antibody to the spike protein that was made from blood of an early Covid-19 patient. They started enrolling patients on Aug 2nd and they plan to enroll 2400 subjects.  Subjects must be at high risk of infection either residing at, or working in a skilled nursing home or an assisted living facility. This is a randomized controlled study with half the patients receiving placebo.  It is also double blind meaning neither the patient, nor staff know what was administered.  Subjects will be followed up for 24 weeks.

The second monoclonal antibody, developed by Regeneron, is actually a "cocktail" of two antibodies which are directed against different places on the virus spike protein.  It too was manufactured from a recently infected Covid-19 patient. They plan to enroll 2000 asymptomatic adult patients who were exposed to a Covid-19 patient living at the same address.  The Phase 3 trial is randomized, placebo-controlled, and blinded to patient, staff, and oversight board so they won't know who received antibodies or placebo until the end of the study.  They will assess subjects for infection at 1 month and continue to follow them for 7 months for safety data.  They started enrolling patients on July 13th. 

 

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