YOU DID IT – THANKS!

What’s My Next Step?

You will receive an email and a text message with an update of your status. If you qualify, you will just need to head to the testing facility.

Be on the lookout for the email or the text because spots are filling up quickly.

Remind Me Of Why This Is Awesome?

Only 10% of Americans participate in clinical research which seems crazy. You, on the other hand, have figured out the following benefits:

  • Study-related care at no cost
  • Compensation for your time and participation
  • Helping to advance research and discover new treatments

f.a.q.

Frequently Asked Questions

What is the purpose of this study?

The purpose of this study is to see if the study medication, upamostat, will help people with COVID-19 to recover sooner. The study will also test the safety of two different doses of upamostat.

What is upamostat?

Upamostat is a drug in the form of a capsule that will be taken orally. Upamostat has not been approved by the FDA for the treatment of any disease, and its use in this study is investigational.

If I have COVID-19, can I participate in this study?

Yes, to participate in this study you must have either a confirmed COVID-19 diagnosis or symptoms of COVID-19 and be willing to take a COVID-19 test provided by a study staff member. You must have started having symptoms or had a positive test for COVID-19 within 5 days.

If I think I have COVID-19 but haven’t been tested, can I participate in this study?

Yes, if you have experienced symptoms of COVID-19 within the last 5 days you may be eligible to participate in this study. Prospective participants will complete a COVID-19 rapid test during eligibility screening for this study to determine if they qualify.

Is this a vaccine study?

No, this is not a vaccine study. The purpose of this study is to determine if upamostat reduces symptoms of people who have COVID-19. The intention of this study is not to determine if upamostat prevents COVID-19.

Will I be compensated for my participation?

Yes. Participants will be compensated based on their completion of study tasks. In addition to financial compensation, you will also be allowed to keep some of the provided study devices to continue personally tracking your vital signs.

Are there any direct benefits to be being in this study?

Your condition may get better, stay the same or worsen during the study. All subjects in the study will be monitored more carefully than they would be if not taking part in the study, including home health visits which are generally not provided to people with this condition.

The information collected during this study may help researchers, scientists and doctors learn more about the study treatment that may benefit you and other people with COVID-19.

How do I know if I am eligible?

Prospective participants will complete an eligibility screening with a member of the study team to confirm full eligibility. Primary requirements include having symptoms of COVID-19 disease and a diagnosis of COVID-19. If you have symptoms, but no diagnosis we can provide you with a test to confirm presence of the virus. You must have started having symptoms or had a positive test for COVID-19 disease within 5 days, whichever is greater, from the planned start of study treatment.

What does my involvement entail?

By participating in the study, you will receive an immediate test for the presence of the COVID-19 virus. If the test shows that you have the infection and you qualify for participation, you will be monitored closely for changes in your health, including the use of devices to check your vital signs. You will be seen by a home health care provider 4 times at your home. The home health care provider will examine you, take blood, and perform a nasal swab test to better understand your condition.

The maximum time you will be in the study is about 57 days. You will only be taking the study medication for about the first 14 days of the study. The remainder of the time you are in this study you will be asked to do various tasks.

What should I expect if I participate in this study?

If you choose to take part in this study, you will be expected to do the following:

  • Take the study drug as you are instructed to do so
  • Complete the study diaries daily as provided via the study app on your smartphone
  • Wear the “BioSticker,” a medical device the size of a credit card that is designed to be discreetly worn on the upper left chest to remotely capture data pertaining to your heart rate, respiratory rate (how many breaths you take), and temperature throughout the 8-week study. This device will continuously capture these measures while being worn and send data to the study team.
  • Record your blood pressure and oxygen level twice a day using a blood pressure monitor and a pulse oximeter provided.
  • Record your weight three times weekly using the scale provided.
  • Record your ECG (electrical tracing of heart activity) up to three times a week using an ECG monitoring device provided.
  • Allow in-person visits from a home health nurse at certain timepoints throughout the trial to record vital signs, perform blood draws, COVID testing, and review health status.
  • Attend 2 remote telehealth visits with the study doctor or staff during the trial to review study and health status.
Are there risks or discomforts to me by taking this study medication?

Some unexpected risks and side effects may occur when you take part in a clinical research study. The study doctor will closely monitor, treat, and try to prevent any side effects that you might experience while participating in this research study. Other drugs and procedures may be provided to make side effects less serious and less uncomfortable.

Will I receive any results from this study?

Using the study devices, participants will be able to monitor various bodily measurements, such as temperature and heart rate. The overall results of the study may be published; however, all protected health information (PHI) that could potentially identify you will be completely removed and all data presented will be de-identified in accordance with HIPAA. The sponsor will not provide any individual results from this study, nor provide results directly to participants.

Are there any direct costs to me for my participation?

You and your insurance company will be billed for all standard care procedures and labs. All costs related to the study are paid by the sponsor.

Is the confidentiality of my health information protected?

The study doctor and some members of the study team will be able to see your health information and it will be used for the purpose of this study ONLY.

Is my participation voluntary, and can I withdraw at any time?

Yes. Your decision to be a part of this study is entirely voluntary. You can decide to stop study treatment at any time during the study. If you wish to stop taking the investigational drug, please let your study doctor know. 

At 1nHealth, we hope you’re as excited as we are to build the future of health together.