Qualmedica Research is currently enrolling two clinical trials focused on a new antibody therapy developed by Eli Lilly. The BLAZE 1 study is for patients 0 – 17 years old with underlying risk factors. The BLAZE 4 study is recruiting patients 12+ with underlying risk facdtors or for patients 18+ with no underlying risk factors (see table 1). You may qualify if you test positive for COVID-19. If you are exhibiting symptoms of COVID-19, Qualmedica Research may administer a free rapid antigen test to see if you qualify for one of these studies.
The investigational drug is a monoclonal antibody (or a cocktail of two different antibodies) that prevents the virus that causes COVID-19 from binding to human cells thereby blocking the virus from rapidly replicating itself. Administration of the drug is by intravenous (IV) infusion and must be started within 3 days of a positive test for COVID-19 if a patient wants to enter one of the studies.
Eli Lilly Granted Emergency Use Authorization for New Antibody Therapy
The FDA has granted Eli Lilly an Emergency Use Authorization (EUA) for this important new therapy. The BLAZE-1 data show that one of the monoclonal antibodies being tested, when given early in the course of disease, may help patients clear the virus and reduce COVID-related hospitalizations. The working hypothesis is that neutralizing antibodies can be an important therapeutic option for patients fighting this virus. The US Government has purchased 300,000 doses of this antibody treatment for distribution across the country. Patients will need to meet specific criteria to be eligible for the therapy and distribution issues are still being worked out. If the therapy is not available in your area or if you do not qualify for treatment, you might consider volunteering for one of the BLAZE clinical trials.
How do the BLAZE -1 and BLAZE-4 Clinical Trials Work?
Clinical trials are highly controlled research studies. Before the study enrolls its first patient, the lead researcher has written a study protocol that explains in great detail how the study will be conducted. The protocol is reviewed in accordance with well documented standards for technical design and ethical concerns.
Volunteers sign an informed consent and must meet certain criteria to join the study. Usually the trial will be placebo controlled. Neither the patient nor the study team know if the patient receives active therapy. For the BLAZE-1 and BLAZE-4 studies, patients will be dosed by IV infusion or IV push and monitored closely for treatment related side effects. The follow-up schedule includes several in-office visits for specimen collection interspersed with telephone contacts over a 1-month period, then safety follow-up visits at the two- and three-month time points. Patient volunteers can withdraw from the study at any time and there is never a fee to participate in a study. Patient stipends and reimbursements may be available.
|Table 1: Primary Inclusion Criteria|
|BLAZE 1 Study||BLAZE 4 Study|
|Pediatric Arm: 0 - 17 years with underlying risk factors||12 - 17 with underlying risk factors (this is an open label study and permits prior COVID19 vaccine)|
|18+ with underlying risk factors (this is an open label study and permits prior COVID19 vaccine)|
|18 - 64 with no underlying risk factors (this arm is placebo controlled and prohibits prior COVID19 vaccine)|
What are the Benefits of Participating One of these Clinical Trials?
Patients volunteer to participate in our studies for different reasons. Sometimes they join a study as a last resort – they have tried available therapy, and nothing has worked. Sometimes their insurance company denies them access to current drugs or they cannot afford the drugs. Many people volunteer because it brings them closer to medical discoveries that improve quality of life for themselves and others.
There are many benefits. In addition to treatment options and personal satisfaction, all patients get close monitoring and free medical visits during the study. They have the support of their research team – the doctors, study coordinators, and office staff that make your visits as comfortable as possible. Most studies include some form of patient reimbursement or stipend. The BLAZE-1 and BLAZE-4 clinical trials have the added benefit of giving COVID-19 patients an option used in combination with the standard of care they receive at their physician’s office. The investigational drug is provided in addition to other COVID related therapies.
How do Patients Volunteer for the BLAZE-1 or BLAZE-4 Clinical Trials?
The study is being conducted at our clinical trial sites in Owensboro Kentucky and Evansville Indiana. If you have recently been diagnosed with COVID-19, or if you feel sick with one or more symptom, volunteers can call Qualmedica Research and telephone screen for study participation. The investigational drug will need to be administered within three (3) days of being diagnosed. If you have tested but are waiting for results, or if you have not yet been tested but exhibit one or more common symptom, Qualmedica Research can administer a rapid antigen test in our office.
Common symptoms include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms or shortness of breath with exertion.
Call for more information:
Bowling Green, KY – (270) 904-4334
Owensboro, KY – (270) 685-4589
Evansville, IN – (812) 205-2475
Toll Free – (888) 866-8020