Dallas Covid trials is a subsidiary of Southwest Family Medicine Research center.
We are excited to present our latest COVID-19 study: Tackle, a study to treat COVID-19 positive individuals to help stop this pandemic.
TACKLE: Treating acute COVID-19 infection with a monoclonal antibody given as I/M injection.
Age: ≥ 18 years old
Laboratory-confirmed SARS-CoV-2 infection (by PCR; antigen or nucleic acid from any respiratory tract specimen) OR signs/symptoms of COVID 19 present within 6 days.
No history or current hospitalization for COVID-19.
Compensation is $165 per visit, with total of more than a $1000 for completing all components of the study.
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:
They have not been vaccinated with a COVID-19 vaccine.
Age is ≥ 18 years.
Have had COVID-19 symptoms for the past 7 days or has a Lab confirmed SARS-CoV2 test (by PCR, Antigen, or Nucleic acid from any respiratory sample).
No History of Hospitalization due to COVID-19 or previous COVID-19 infection.
We will compensate you for your time $165 after completion of each visit. The total sum is nearly $1000. Last but not least we will provide transportation to those in need.
COVID Trial Q & A
Where are the trial sites located?
We are located at 8877 Harry Hines Blvd Suite # 100 Dallas Texas 75235.
Will participating in this trial cost me anything?
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.
Do I need health insurance to participate?
No, health insurance is not required to participate in the TACKLE trial.
How long is the 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.
What does trial participation involve?
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.
What if I am not currently experiencing symptoms?
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.
Can I participate if I have already received the COVID-19 vaccine?
No, if you have already been administered the COVID-19 vaccine, you are not eligible to take part in the trial.
Will I still be able to have the COVID-19 vaccine?
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).
If pre-qualified, what can I expect on my first visit to the trial site?
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.
What is the investigational medicine that is being tested?
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.
What is a monoclonal antibody?
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.
Has this investigational medicine been tested before?
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.
What about my current medication?
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.
Why I did not qualify?
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.