Purpose of the Study

This research is conducted by Donald Milton, MD, DrPH and researchers at the University of Maryland. It is funded by the University and federal government sources including the U.S. Department of Health and Human Services. The purpose of this research is to find out how people transmit COVID-19 and how to prevent transmission. Daily surveys and weekly testing of healthy people will help us identify people with infections early and without symptoms. Breath testing of people who have recently been infected will help us answer several important questions. How much airborne virus does an infected person exhale? How much virus is released into the air when an infected person breathes, talks, or sings? How well do surgical and homemade masks block release of airborne virus? This work will help us understand whether airborne transmission is important and how to prevent it. Another goal is to gather samples that can be used to better understand how the body fights the infection. This will help with future research to develop new medications and vaccines to treat and prevent COVID-19. We invite you to participate because you have expressed interest in being screened because of possible exposure to persons with COVID-19.

Procedures

➢Study Overview

We will ask you to participate in daily surveys and weekly testing to detect COVID-19 early, even if there are no symptoms. You will:

• Sign up online and answer an online survey

• Answer a daily survey on your phone about your

  • Symptoms

  • Temperature

  • Exposure to the virus

• Collect your own saliva (or nasal swab):

  • Once (at most twice) a week

  • Bring it to the College Park campus

You can also get a wearable electronic device to test whether it can detect early signs of infection.

➢Factsheet and Consent Form

Please read this consent form and the “Factsheet–Understanding Your COVID-19 Test Results”. The fact sheet explains what the testing means and how results will be handled. Please note: the results of this testing are for deciding on your eligibility for research. This testing cannot be used for diagnosis. The results are for research only.

If you decide to participate, you must correctly answer a few questions about the study at the bottom of this consent form to make sure you understand. After you complete the short quiz we will ask you to sign this form online. We will email you a copy of the signed form.

➢Enrollment Questionnaire

Immediately after you agree to participate (by signing this form) we will ask you to complete a secure online survey. The survey will ask for your:

• Contact information: name, email address, affiliation with UMD and UID (if any), mobile phone number, local residential address, and emergency contact including primary medical provider.

• Demographic information: date of birth, sex, race, ethnicity, education, employment, and income category.

• Medical history and health behaviors such as tobacco and alcohol use.

• Up-to-date vaccination status.

• Residential conditions.

• Symptoms that you may have had over the previous seven days.

➢Testing for COVID-19

After you complete the questionnaire, we will instruct you on how and when to collect your samples for COVID-19 testing. We may ask you to collect a sample of your saliva r to swab the inside of your nose. The type of sample we ask you to collect will depend on current conditions during the pandemic. We will tell you where at the UMD campus to pick up and drop off your sample kit. One location will be an outdoor protected area at the School of Public Health. The place and time for sample pick-up and drop-off will be arranged via phone, email, or text.

You will be asked to collect and drop off your sample 1-2 times per week and at least once every two weeks, depending on testing capacity. It typically takes only a few minutes to collect your sample. (See below for a brief description of how to collect these samples.) You may be asked to download and use an application on your phone for sample collection. This app will gather information including sample collection date and time, drop-off time, and sample barcode number.

➢Daily symptom reporting and temperature measurement

After you join the study, we will send you a daily text message that contains a link to a secure online survey. This will ask you to rate several important symptoms and whether you’ve consulted a healthcare provider. We will ask whether anyone else in your household has recently been sick or you have been around someone with COVID-19. We will also ask you to take your temperature and record it. If you don’t have a thermometer, we may be able to supply one. This typically takes 30 seconds to less than one minute each day.

We will review your symptoms and temperature every day. After we do the review, we may ask you to give an extra saliva or nasal swab for testing. Or, we may ask you to come to the research clinic for follow-up.

➢ COVID-19 case assessment (if indicated)

If the temperature and symptoms you tell us about on the daily survey meet our criteria, we may ask you to provide a nasal swab or saliva sample for research testing as soon as possible.

If your sample tests positive for COVID-19 we will contact you immediately. We will review the fact sheet with you. We will remind you that our test is for research only. You will need to have a test in a certified clinical lab to diagnose infection. We will ask you to contact the University Health Center or your medical provider. We will also notify the University Health Center or your

medical provider and the county health department. The medical providers and the health department will decide what testing and treatment you need.

If your sample was in a pool that tested positive, we will contact you immediately. We will instruct you to go to the University Health Center, your primary care medical provider, or another site for a certified clinical test. Only a certified clinical test can be used to diagnose you. We will notify the University Health Center and your medical provider that your sample was in a positive pool. We may also ask you to provide another sample for additional research testing.

If your individual sample is positive, we will invite you to participate in a separate aerosol shedding and transmission part of the study. We will ask you to schedule an appointment to be seen at the research clinic as soon as possible. We will send you a separate consent form that describes in detail what you would be asked to do.

If your symptoms suggest you may meet CDC or Maryland Department of Health criteria for triage to urgent medical care, or if a supervising clinician determines that you require urgent medical intervention, we will not ask you to come to the research clinic. We will instead advise you to seek medical attention, calling 911 if indicated.

➢ Oral Temperature

When measuring your oral temperature, we ask you to wait 10-15 minutes after eating or drinking. This is particularly important if food or drink is not at room temperature, to help ensure an accurate reading. Place the tip of the standard oral thermometer probe under your tongue on one side of your mouth. You should place it as far back as possible, next to the back molar. Be sure to follow the thermometer directions, and repeat if necessary to get a good result.

➢ Saliva Samples

If we are using saliva to test for COVID-19, we will send you an instruction sheet to show you how to collect your saliva sample. We will also send directions for how to pick up and drop off of your saliva sample kit. We will ask you to collect approximately 0.5-1 mL of your saliva, which can usually be accomplished by spitting into the tube 2-3 times. Please make sure that you collect your saliva sample immediately after getting up and before brushing teeth, eating, drinking, or chewing gum in the morning.

➢ Self-collected Nasal Swabs

If we are using nasal swabs to test for COVID-19, we will send you an instruction sheet to show you how to swab your nose. We will also send directions for pick-up and drop-off of your nasal swab kit. We will ask you use a small, soft swab that is specially made for this type of sample. You will need to gently insert the swab about 1.5”-2” into one of your nostrils until the stopper along the swab shaft is just outside the opening of your nose. We will ask you to leave the swab in place and gently rotate it for up to 15 seconds before removing it. Next, we want you to repeat this process on the other nostril with the same swab. Immediately after swabbing your nose please place the swab into the collection tube in the kit.

Potential Risks and Discomforts

There is a risk of incorrect test results. We believe the risk is fairly small, but we don’t know for sure. The University of Maryland research lab performing the tests has years of experience with similar tests. We use a commercial test kit that that is used by many clinical laboratories. However, our research lab is not a certified clinical laboratory. Your sample may be tested in a pool with other samples. If we get a positive result from a pool we may need to ask you to collect a second sample or refer you to a clinic or testing center. Please see the “Factsheet–Understanding Your COVID-19 Test Results” for a detailed description of the tests and what the results mean.

Risk of catching COVID-19 through study participation will be no greater than the risk you have anytime you leave your home. Sample kits are prepared by staff who are monitored and excluded if possibly infected. Staff members use gloves and masks to prevent contamination of the sample kits. Sample pick up and drop off locations and times will be arranged to ensure physical distancing at all times.

Your participation in this study may take time away from other activities or time you may have spent resting and recovering, if you become sick. We ask that you come to campus 1-2 times per week to drop off your saliva sample or nasal swab for testing. Providing a saliva sample involves clearing the throat and may be uncomfortable if you have a sore throat. You may experience some mild pressure or discomfort, a tickling sensation, eye watering, or sneezing when you swab your nose. In rare instances, swabbing inside the nose may cause minor bleeding.

You may not feel well while participating in the study due to symptoms from an illness. There is no reason to believe that study participation would worsen your symptoms any more than a visit to a health care provider. You may feel some embarrassment when providing information about your medical history or habits. We will minimize your potential embarrassment by allowing you answer the questions in a private setting on a computer, tablet, or smartphone. There is a small risk to your privacy and confidentiality, since we are collecting personal data from you. We will do our best to keep your personal information confidential and limit access to only essential study personnel. All data will be transmitted between the electronic device used to enter your data (a computer, tablet, or your phone) and the server via encrypted connections. The server will be housed in a high security data center as described below under confidentiality.

Potential Benefits

You could potentially benefit from participating. If you test positive, you may be infected with COVID-19. Early detection of COVID-19 may give you the chance to get early medical treatment from a healthcare provider. Early detection may help you to avoid infecting family members. Please be aware that all of the tests we perform are for research only. Our tests are not FDA-approved clinical diagnostic tests. If your sample is positive, we will immediately refer you for medical follow-up. The medical provider and the county health department will decide if you need an FDA-approved test. We will also suggest you stay away from others to decrease the chance of spreading the infection.

We hope that, in the future, other people might benefit from this study through improved understanding of COVID-19. We want to find out whether mild early infection is associated with shedding airborne viruses. This will help develop better ways to reduce the spread of the infection. If you become infected and participate in other parts of the study, your blood samples will be used to study the body’s immune response to the virus. This may assist in the development of medical treatments.

Confidentiality

Any potential loss of confidentiality will be minimized by storing all data in an encrypted database maintained on a secure server in a high security data center. Only essential study personnel have access to this data. Access to data is limited. Only staff with an operational need for particular information will have access to sensitive information. Undergraduate research assistants only have access to the database while working in the clinic under senior staff supervision. You have been assigned a subject ID number which will be used by research staff to access your records in the database.

All biologic samples will be labeled with a unique sample ID number. This can only be linked to your personally identifiable information by Dr. Milton and his designated research staff. The sample labels will not contain your name or other personally identifiable information. Samples will be stored in laboratories with controlled access at the School of Public Health. Some samples may be deposited in a secured storage system maintained by the University of Maryland or the National Institutes of Health. This system is for long term storage and distribution of samples to other laboratories for research on respiratory infections, especially COVID-19. Samples will be retained indefinitely until used up or there is no longer sufficient scientific justification for the cost of maintaining them in storage.

We will not disclose personally identifiable information about you to anyone outside of the research team, unless you test positive for COVID-19 or another infection where public health reporting is required. If you test positive for COVID-19 we will inform you and the State and County Health Departments and CDC. We will immediately refer you for medical follow-up and isolation.

Collaborators within and outside the University of Maryland will conduct analyses on your samples or data for research purposes. All such samples or data will always be de-identified. We may report a summary of group results on our study website. If we post information on the website or write a report about this research project, your identity will be protected to the maximum extent possible.

Your information may be shared with representatives of the University of Maryland, College Park or governmental authorities in certain special situations. We must share your information if you or someone else is in danger or if we are required to do so by law. The Code of Maryland Regulations (COMAR) 10.06.01.03 C, requires reporting certain infectious diseases to the Maryland Department of Health and Mental Hygiene. This includes reporting personally identifiable information in the event of any disease outbreak that poses a danger to public health, such as COVID-19. It also requires reporting of cases of Measles, Mumps, Pertussis and Legionellosis, which may be tested for in samples that we collect. Measles is a highly contagious virus that causes respiratory infection and rash. Mumps is a somewhat less contagious viral illness that typically causes swollen tender salivary glands. Pertussis, also known as whooping cough, is a highly contagious bacterial respiratory infection. Legionellosis (also known as Legionnaire’s Disease) is a bacterial infection that can cause pneumonia or flu- like illness. Measles, Mumps, and Pertussis can all be prevented through proper vaccination.

Any unanticipated problems involving risks to participants or others such as unexpected or serious adverse events, non-compliance, audits, and investigation reports will be promptly reported to the University of Maryland Institutional Review Board. We will also send a report to the U.S. Department of the Navy and Naval Information Warfare Center Pacific Human Research Protection Programs, if applicable.

Medical Treatment

The University of Maryland does not provide any medical, hospitalization or other insurance for participants in this research study. The University of Maryland will not provide any medical treatment or compensation for any injury sustained as a result of participation in this research study, except as required by law.

Compensation

No monetary compensation.

Right to Withdraw and Questions

Your participation in this research is completely voluntary. You may choose not to take part at all. If you decide to participate in this research, you may stop participating at any time. If you decide not to participate in this study or if you stop participating at any time, you will not be penalized. You will not lose any benefits to which you otherwise qualify. Your academic standing as a student or employability at UMD will not be affected by your participation or non-participation in this study.

Special notice for research assistants: If you are a student working on the study and are earning course credit for your work, your grade will not be affected by your decision to participate (or not participate) in this study.

If you decide to stop taking part in the study, if you have questions, concerns, or complaints, or if you need to report an injury related to the research, please contact the investigator:

Dr. Donald Milton

Room 2234V, SPH Building 255

University of Maryland

College Park, MD 20742

Telephone: 301-405-0389

Email: dmilton@umd.edu

Participant Rights

If you have questions about your rights as a research participant or wish to report a research-related injury, please contact:

University of Maryland College Park

Institutional Review Board Office

1204 Marie Mount Hall

College Park, Maryland, 20742

E-mail: irb@umd.edu

Telephone: 301-405-0678

This research has been reviewed according to the University of Maryland, College Park IRB procedures for research involving human subjects.

Statement of Consent or Assent and Permission

Your signature indicates the following:

• You are age 18 or older. If you are younger, your signature indicates that you are either enrolled as a student at the University of Maryland or that your parent will also sign to give permission.

• You have read this consent form or have had it read to you.

• Your questions have been answered to your satisfaction.

• You voluntarily agree to participate in this research study.

You will be sent a copy of this signed consent form via email, which you may print.

Use of samples: Your signature also indicates that you agree to use of your samples for research on COVID-19 and other infections, immune response to infections, and for similar future research studies for which they may be helpful. Your samples may be used by researchers both inside and outside of the University of Maryland. For example, researchers at the University of California, Irvine may measure antibody levels in your blood samples. We may also send your samples to the Walter Reed Army Institute for Research for viral DNA sequence analysis. Please note that no personally identifiable information will be provided to researchers outside of Dr. Milton’s laboratory. If you do not want us to use your samples in this manner you should not sign this consent form.