Research Center: University of California San Diego
Location: This is a virtual study within Southern California
Lead Researchers: Gordon Saxe, MD, PhD; Andrew Shubov, MD
IRB Committee: This study has been reviewed and approved by the University of California San Diego Institutional Review Board

Background

Despite biomedical advances, medical intervention for COVID-19 is largely limited to vaccination and supportive care during the later stages of the disease. Mother Nature’s pharmacy offers several promising antiviral and immunomodulatory therapeutics that have been used for thousands of years and warrant studying. 

Researchers at the University of California San Diego are investigating two separate natural products to treat non-hospitalized COVID-19. The study product will be administered orally through capsules. This is a virtual research study, meaning that all interactions are done from the comfort of home, and is the first-ever study to receive FDA approval to evaluate mushrooms and Chinese herbs to potentially treat COVID-19.

Interested participants must have been diagnosed with COVID-19 and are aged 18 years or older. Participants must comply with the necessary study requirements.

Why Participate? 

• You will potentially receive an experimental natural treatment for COVID-19 at no cost.
• You will contribute valuable information that may benefit the community during this pandemic.
• You may help develop a natural therapy to fight COVID-19.
• You may experience improvements in your symptoms. 
• You will help to advance research on COVID-19 and natural medicine.
• You will receive $250 for your participation upon completion of the study.

Your Rights

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

• Participants must be 18 years of age or older and have been diagnosed with COVID-19 within the past 72 hours.
• Participants must not be experiencing symptoms that need medical attention (i.e.,  hospitalization).
• Participants must be able to commit to this virtual study for approximately 60 days. The greatest time commitment will be during the first 14 days, and the overall time commitment for this study will be about 5 hours. Participants will be assigned to one of 3 groups at random.
• Participants will be sent a study kit and capsules (the study team will provide all the details on the process). Participants must be willing to take 8 capsules of the investigational product 3 times a day for 14 days as instructed by the study team.
• Participants must be willing to communicate with the study team via phone calls, texts, or emails as well as fill out diary entries, answer various surveys and assessments. This study involves blood samples being drawn twice at your home. The study will collect 25ml of blood, and participants have the option to also provide an additional 50ml if they so choose.

About the Research Centers:

Please note:

Due to the current situation with the COVID-19 pandemic,  please note the following:

• This is a virtual study, which means you will participate from the comfort of your own home. 
• There will be no in-person clinic appointments. The only in-person contact will be two visits to your home by a phlebotomist to draw blood samples. The rest of the communication will be via phone, email, or text.