By the time you learn about a new medication, it has been in the research pipeline for many years. The final phases of clinical research, called clinical trials, are conducted by highly experienced physicians across the country, including Dr. Safia Shaikh and Dr. Chrisette Dharma at Southwest Family Medicine Associates in Dallas. Clinical trials depend on volunteers who would like the opportunity to try cutting-edge treatments. Now actively enrolling patients for two different Covid clinical trials. If you have any questions or would like to participate in clinical research, please call the office today at 469-893-1242.
AstraZeneca will look at a combination of two monoclonal antibodies for the treatment of COVID-19. The study is looking at how well the antibodies work in the treatment of COVID-19 positive patients or those with symptoms of Covid-19.
In this study, adult participants will be randomly assigned (by chance) to receive two injections at one time of either the investigational monoclonal antibodies or a placebo (injection of water). Participants will not know if they receive investigational antibodies or a placebo. There is 50% chance of receiving the investigational antibodies than of receiving the placebo.
Research has shown that certain diseases and medications may impact people differently based on their age, gender, and genetic background, including race and ethnicity. For example, COVID-19 has disproportionally impacted both older people and minority populations.
Our aim is to bring this cutting-edge medication to the ethnic communities disproportionately affected by social determinants of health which are barrier to getting health care needs addressed, such as access and affordability. Your help is appreciated in decreasing the burden of COVID 19.
Patient qualifies if:
We are located at 8877 Harry Hines Blvd Suite # 100 Dallas Texas 75235.
There is no cost to either you or your insurance provider for participation in this trial. You will be reimbursed $165 for your time and travel.
No, health insurance is not required to participate in the TACKLE trial.
The TACKLE trial will last a little over 1 year for all participants. During this time, you will have approximately 10 trial visits, where you will undergo a series of assessments. Some of the visits will require you to attend the trial clinic, while others may be conducted in your own home, depending on your preference, health and any current restrictions. It is important to remember that once you consent to participate in the TACKLE trial, you are free to withdraw at any time.
All enrolled participants would receive the investigational medication or a placebo by injection on Day 1 of the trial, and then would be closely monitored during approximately eight further trial visits (home or trial clinic) until the end of the trial.
If you are not currently experiencing symptoms, either because your symptoms have cleared or you have never had COVID-19 symptoms, then you are not eligible to participate. If, however, you start to experience symptoms, you may then become eligible. You may call us back at 469.893.1242 to see if you may be eligible at any time.
No, if you have already been administered the COVID-19 vaccine, you are not eligible to take part in the trial.
If you are offered access to the COVID-19 vaccine whilst on the trial, this can be discussed with your Research Doctor (Dr. Chrisette Dharma).
During your first visit to a TACKLE trial site, you will learn more about the trial. You’ll be able to speak with a doctor or trial coordinator about your participation in the trial. You can ask any questions you may have about the TACKLE trial or clinical research in general. You can determine if the TACKLE trial is right for you. If you decide that it is, then you will be asked to sign a consent form. The research staff will then perform a series of screening assessments to determine if you’re eligible to participate.
The TACKLE clinical trial is researching the investigational medication, AZD7442, which is aimed at targeting SARS-CoV-2 (the virus causing COVID-19). AZD7442 is a combination of two monoclonal antibodies. By their combined action, the two antibodies may be able to prevent the virus from entering human cells, and therefore reduce the amount of virus spreading inside the body. It is thought that this may be able to prevent severe disease and damage.
Antibodies are substances that are made naturally by the body. They are made by the body’s immune system, to help fight infections. A monoclonal antibody is a manufactured antibody, similar to the type of antibody that is most abundantly produced by the body. Each monoclonal antibody is designed to ‘stick’ to a single specific thing, such a specific infection. The antibodies being used in the TACKLE trial are similar to the ones made naturally by the body in response to an infection of COVID-19.
The investigational medication has been tested in small numbers of healthy volunteers. In the TACKLE trial, we are looking to test this in a larger group of people with a current COVID-19 infection.
Is there a placebo? Participants in the TACKLE trial will be randomly assigned to either the investigational medicine or a placebo. There is a 50% chance of receiving the investigational medicine, and neither you nor the trial staff will know what you are assigned. All participants will still receive standard of care treatment regardless of whether you are assigned a placebo or the investigational medicine.
You should not discontinue any medication unless advised to do so by either the trial staff or by your primary care physician. If you do have to stop taking your regular medication or therapy during the trial this will be fully discussed with you at the trial site.
Clinical trials are rigorously designed to test the investigational medicine for safety and effectiveness. One or more of your answers to our questions have placed you outside of the strict eligibility guidelines for this particular trial. That does not mean however, that you will not qualify for different research trials either now or in the future.
Let’s make a difference together
in finding new ways
to prevent and treat Covid
so we can back to our lives.