The supplement is a commercially available dietary supplement that is extracted from plants.
We are not trying to promote unproven treatments for COVID-19, therefore we will not describe the contents of the trial treatment at this time.
When the study is complete, we will announce what the supplement contains.
Are there side effects?
Prior human studies of the supplement have show that most people experience no side effects. However, some patients do experience gastrointestinal upset (such as nausea, gas, bloating, and mild diarrhea).
Taking the supplement with food is expected to decrease these side effects.
One of the purposes of this study, it to determine the side effects that patients with COVID-19 taking this supplement will experience.
What am I expected to do if I enroll in the study?
You will be asked to take 2 capsule of either the supplement or placebo (we won't know which until the study is over) 4 times per day for 15 days.
You will also take 2 capsules containing Vitamin D on just the first day of the study.
Each day, before bedtime, we ask that you complete an online survey to report how you are doing. The daily survey is expected to take about 5 minutes.
There will also be longer (approximately 20 minute) surveys on days 1, 8, 15, 21, 30, and 60. These longer surveys are important to identify possible adverse events.
What does it cost to participate in the study?
The are no fees to you or your insurance to participate in this study.
You will be provided, free of charge, with the study supplement (or placebo) as well a finger pulse oximeter (a device to measure your oxygen and heart rate).
You or your insurance provider will be responsible for all other costs related to your illness. (the consent form provides more details).
What if I am hospitalized during the study?
You will be asked to discontinue the study supplement. The supplement is not a replacement for your usual medical care.
Who can enroll in the study?
The study is by invitation only. Participants will be 45 years and older.
Patients will be recruited from outpatients who test positive for COVID-19 from within the Mt Carmel Health System.
Can I withdraw from the study?
Participation is this study is completely voluntary.
You can withdraw at any time.
The consent form provided during enrollment covers the details.
Can I take other medications while on this supplements?
There are some medications take may interact with the supplement being studied, and might exclude you from this study. This will be reviewed during the enrollment process.
We will also ask that you do NOT take other over-the-counter dietary supplements while participating in this study.
Enrollment in the study is NOT a replacement for your usual medical care. If not excluded during enrollment, you will continue to take your usual medications as prescribed by your primary care provider.
You may also take medications as usual to treat the symptoms of COVID-19 (e.g. cough medications and fever reducers).
We will ask you not to enroll in any other COVID-19 treatment studies while on this medication.