About the Study
The goal of this study is to examine the effectiveness of lactoferrin, an over-the-counter dietary supplement isolated from bovine milk whey, in treating early COVID-19. Currently, there are few treatment options available for those with COVID-19; lactoferrin potentially represents a commercially available treatment option to those with COVID-19 who are not sick enough to be hospitalized. To assess the effectiveness of lactoferrin as an early treatment option, the study will provide either lactoferrin or a placebo to people newly diagnosed with COVID-19 for 14 days and measure their viral load through a series of COVID-19 tests throughout the treatment duration. The study will also record changes in symptoms throughout the course of treatment. The hope is that this study will provide evidence that lactoferrin is an affordable, effective option for the treatment of COVID-19.
What would my participation look like?
This study will be fully remote, meaning that if you participate, you will not have any in-person contact with the study team. The study team will reach out to you following a positive test result for COVID-19 through the University Health Service or the U-M Community Sampling and Tracking Program, both of which are available only to University of Michigan students or employees. If you have received a positive test result through one of these services and have not yet heard from a study team member, you may also contact us using the contact information found on the bottom of this page. We are not accepting volunteers who were tested outside of these services for students and employees.
A study team member will discuss the study with you and answer any questions you may have prior to having you sign a consent form remotely. After you have signed consent, you will be shipped a package containing either the lactoferrin or placebo (you will not know which you receive and neither will the study team), collection kits for at home COVID-19 testing, a pulse oximeter to measure your oxygen saturation, and a thermometer to take your temperature. You will be asked to take the provided medication 4 times a day for 14 days, 1 tablet each time, preferably on an empty stomach. You will also use the provided kits to do an at home COVID-19 mid-turbinate swab on day 0 (the day you receive your package), and days 2, 4, 6, 8, 10, and 14. These swabs will be picked up from you by a courier working with the study and brought back to the University.
In addition to taking the tablets and completing the at-home swabs, you will also be asked to report any medications you are using to treat your COVID-19 and track your symptoms by completing a daily symptom diary sent to you through either a text or email. Your participation in the study will be complete after a 30-day follow-up interview where the study team will check in with you to see how you are doing.
What will I receive for participating in the study?
You will potentially receive lactoferrin as a treatment for your COVID-19, however, both you and the study team remain blinded as to which group you are in. This study does not provide monetary compensation.
How do I know if I am eligible to participate?
You are eligible to participate in this study if:
- You are at least 18 years old
- You have not been admitted for hospitalization due to COVID-19 at the time of enrollment
- You have had a positive COVID-19 test within 48 hours of enrollment from University Health Service or through the U-M Community Sampling and Tracking Program
- You are available to complete the study and follow the procedures and medication regimen
- You are able to read and understand the informed consent
- You are able to understand/read/speak English
There are some factors that may prevent you from participating even if you meet the above criteria, but the study team will discuss these with you to see if they apply to you.
Who can I contact for more information about this study?
Study Coordinators:
| Ashley Cawthon
Phone: (734) 764-7987 Email: acawthon@med.umich.edu |
Elaine Brady
Phone: (734) 647-4794 Email: embrady@med.umich.edu |
The lactoferrin used in this study is being provided by Glanbia Nutritionals, Inc.
This study is pending approval from the University of Michigan Medical School Institutional Review Board.