A research study testing an experimental COVID-19 treatment called anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG).
What Does the Study Involve?
The Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) study is testing hIVIG as a treatment for COVID-19 (SARS-CoV-2).
What is hIVIG? hIVIG stands for “hyperimmune intravenous immunoglobulin.” hIVIG is made from blood plasma donated by healthy people who have recovered from COVID-19. Plasma is the liquid part of your blood.
The plasma is collected and purified to make hIVIG. It contains high levels of antibodies that fight the virus that causes COVID-19. Antibodies are natural proteins made by the body to fight or prevent infection.
The OTAC study is testing hIVIG to answer the following questions:
- Can this drug help people have fewer COVID-19 symptoms?
- Can the drug help people with COVID-19 stay out of the hospital?
- Is this drug safe for people with COVID-19 who may have a higher risk of getting very sick from their infection?
If you join this study, you will receive one dose of either hIVIG or a placebo (salt water which has no drug in it). Your chance of receiving the study drug will be 50%, which is just like flipping a coin. You will get the drug or placebo as a drip through a small plastic tube that is put into a vein in your arm. The study team will watch you while the dose is being given. They will also watch you after the dose is given. You will get the usual standard care for COVID-19 that you would receive even if you were not in a study. Your decision to join the study is purely up to you, and you can change your mind at any time.
How hIVIG Production and Administration Works
- Plasma is removed from blood donated by other people who have gotten better from COVID-19.
- Antibodies are separated from the plasma in a lab.
- This results in a drug product with a high-concentration of antibodies against SARS CoV-2, the virus that causes COVID-19.
- hIVIG is given in OTAC through a plastic tube placed in a vein (blood vessel).
- The antibodies may attach to SARS CoV-2 and prevent it from entering cells and multiplying. This may reduce the amount of virus in the body.
Who Can Participate?
If you recently tested positive for COVID-19, this study may be for you. Clinical trials testing investigational COVID-19 treatments need people from diverse backgrounds. This will help researchers find treatments that work for more people. Each person who takes part in the OTAC study will meet specific conditions, including:
- Age – At least 55 years old OR at least 18 years old with a weakened immune system or on medication that suppresses the immune system
- COVID-19 Status – Not currently in the hospital, and tested positive for COVID-19 within the past 5 days
- Symptoms – No symptoms OR COVID-19 symptoms for no longer than 5 days
There are other requirements that the study team will explain to you. If you do not meet the requirements, or if there is not a study site near you, there may be other COVID-19 studies that you can participate in.
Where Is It Taking Place?
Visit ClincialTrials.gov to find an OTAC trial site near you.
Number of Visits Required
Your participation in this study will last for 28 days. You will check your temperature and your oxygen levels at home. Your study team will give you easy-to-use equipment at no cost to you to do this. Your study team will check on your health the day after the dose and then four more times after that. Most of the health checks can be done over the phone.
- Day 0 – Study drug or placebo given; blood and nose swab samples taken
- Days 1-7 – You take your temperatures at home and measure your oxygen levels every day
- Day 1 – Phone check-in
- Day 4 – Phone check-in
- Day 7 – Phone check-in or visit to study site; blood and nose swab samples taken
- Day 14 (+/-2) – Phone check-in
- Day 28 (+/-2) – Phone check-in
Steps to Participate
If you are interested in joining the OTAC clinical trial or you would like more information email email@example.com.
Study Information Video
Study Information Downloadable Presentation
Answers to Other Questions You Might Have
What Are Clinical Research Studies?
A clinical research study helps experts find treatments that are safe and effective. It is important that these studies include people from diverse backgrounds. This helps researchers develop and test new treatments that will work for more people.
What Is a Placebo?
The placebo looks like the study medication but does not have any active ingredients in it. Researchers compare how people react to both placebos and medications to learn if the medication is safe and helps people recover more quickly. If you join this study, you will get the usual care for COVID-19.
Can I Change My Mind After I Join the Study?
Yes. Taking part in this clinical trial is voluntary; it is your choice. You can change your mind at any time and leave the study.