FREQUENTLY ASKED QUESTIONS ABOUT COVID-19 CLINICAL STUDIES
We have several procedures in place to protect both our participants and our staff. These include maintaining social distancing, following prevention guidelines such as face coverings, sanitization, and temperature readings, and increased clinic sanitization.
Additionally, some of the study procedures might take place electronically, by phone, or using person-to-person video conferencing.
No. We will enroll people who may be more likely to be exposed to SARS-CoV-2 infection and COVID-19 illness in their everyday lives, like where they work. Some participants will get the vaccine, and some will get a placebo, which is a sterile saline solution that does not have any vaccine in it – this what the “randomized controlled trials” are designed. We expect that some people will be exposed to the virus in their everyday lives, and may become sick. We will compare the 2 groups to see if there are fewer people who get sick in the vaccine group than in the placebo group. This is how we will know if the vaccine works.
No, you cannot get COVID-19 from a COVID-19 vaccine or any other study product we are testing.
The vaccines we are testing do not contain real severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) virus, which is the virus that causes coronavirus disease 2019 (COVID-19). Instead, these vaccines use man–made imitations of pieces of the virus. The idea is to trick your body’s immune system into creating a response to a threat that isn’t there. Hopefully, then, if you are ever exposed to SARS-COV-2, your body will know how to fight it.
Think of it like parts of a car. If someone handed you a steering wheel and some tires, you would know they were parts from a car, and you could practice steering or changing a flat. But you couldn’t use just those parts to get yourself across the Bay Bridge.
Yes, people who join a study get compensated for their time, transportation, and inconvenience. You will be paid up to $150 for each visit, depending on the visit. You will also be provided with free COVID testing.
All vaccines can cause fever, chills, rash, aches and pains, nausea, headache, dizziness, and feeling tired. Vaccines can also cause pain, redness, swelling, or itching where you got the injection. Most people can still do their planned activities after getting a vaccine. Rarely, people experience side effects that limit their normal activities or make them go to the doctor.
Rarely, a vaccine can cause an allergic reaction, including a rash, hives, or difficulty breathing. Allergic reactions can be life-threatening. You should tell us if you have ever had a bad reaction to any injection or vaccine. There may be other side effects that we don’t yet know about.
We are often recruiting for more than one study at the same time. When you call us, we’ll be able to figure out which study is the best fit for you. Studies can last from several months to a few years.
No. We need and want participants from all over the Bay Area. However, you will need to come to our clinic in San Francisco for your visits.
The short answer is we don’t know. It could take a short amount of time or it could several years. We do know that a COVID-19 vaccine is the only way we will stop this pandemic and to find a vaccine we need thousands of people, like you, to volunteer for research studies.
All research activities at Bridge HIV are in full compliance with international standards of ethical protections for research studies. We get—and pay attention to—input from our Community Advisory Group, and the UCSF Institutional Review Board oversees studies every step of the way. We put many safeguards in place to protect your privacy.
Participant safety is always our top priority. Before enrolling, study participants go through a process called informed consent, during which they learn all of the risks, benefits, and responsibilities of study participation. We tell you everything you need to know up front.
Participants have access to study staff at all times to address any questions or concerns. Participants can withdraw from the study at any time.
Additionally, during this time of COVID, we are taking additional safety precautions in our clinic.
Unlike guinea pigs, people can say yes or no about joining a study. All study volunteers go through a process called informed consent that ensures they understand all of the risks and benefits of being in a study, and those volunteers are reminded that they may leave a study at any time without losing any of their rights or benefits.
There is no approved vaccine against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), which is the virus that causes coronavirus disease 2019 (COVID-19). Scientists are working very hard to develop a vaccine and an antibody and do the research to determine whether they are safe and effective against SARS-CoV-2.
No. We want to ensure that vaccine access is fair and equitable. In order to find a vaccine that works in all kinds of people, it is necessary to test them in all kinds of people. This is especially true for groups of people that have been hardest hit by the COVID-19 pandemic. Protecting the well-being of study volunteers is the greatest responsibility in every study, and we work to make sure that our studies follow the highest ethical standards. These studies are done in collaboration with local scientists and researchers and community representatives with oversight by ethics and regulatory groups in each country. Many studies are done in sub-Saharan Africa, Europe, North America, and South America at the same time and follow the same procedures and international standards no matter where the study takes place.
No. The vaccines being tested are preventive products. They must be tested on volunteers who do not have COVID-19, because the goal is to keep people healthy.
It is true that vaccines often have side effects, but those are typically temporary (like a sore arm, low fever, muscle aches and pains) and go away after a day or two.
Many studies have proven that there is no link between vaccines and autism. And, the study often referenced to show a link between vaccines and autism was found to be a fraud. There is also no link between childhood vaccination and autism. The British doctor who originally published the finding about vaccines and autism has since been found to have falsified his data and was stripped of his license to practice medicine. The value of protection among vaccinated individuals and to the public has made vaccines one of the top public health measures in history, second only to having a clean water supply.
FREQUENTLY ASKED QUESTIONS ABOUT COVID-19
A novel coronavirus is a new coronavirus that has not been previously identified in people. The new virus called severe acute respiratory syndrome coronavirus type 2, also known as SARS-CoV-2, causes coronavirus disease 2019, also known as COVID-19. This is not the same as the coronaviruses that commonly infect people and cause mild illness, like the common cold.
No. People of all ages can be infected by SARS-CoV-2, the virus that causes COVID-19. However, older people and people with some chronic health conditions are more likely to get sick.
No. COVID-19 can affect anyone, regardless of their race or ethnicity. However, data show that it is disproportionately impacting Black, Latinx, and Native American communities. This is largely due to social and structural factors that impact some communities more than others. These factors include poverty, housing inequality, poor access to medical care, and limited resources, among others.
No. Antibiotics help stop bacterial infections and are not effective against viruses such as SARS-CoV-2.
No. Some people who get SARS-CoV-2, the virus that causes COVID-19, experience flu-like symptoms. However, COVID-19 currently has a higher death rate than the flu and is easier to spread than the flu.
Yes. Scientists have found that people who have SARS-CoV-2 and have no symptoms (i.e., asymptomatic) can still pass SARS-CoV-2 to others. In fact, people infected with SARS-CoV-2 seem to be most infectious for the two days before they start to show symptoms.
The FDA is reviewing many drugs as potential treatments, but nothing has yet been approved to treat or prevent COVID-19. The FDA is also identifying treatments, such as Remdesivir, to help ease the symptoms and help people recover more quickly. Remdesivir has emergency use authorization from the FDA for use among hospitalized patients with severe COVID-19 disease.
Face masks can reduce your chances of getting SARS-CoV-2, but the primary purpose of face masks is to protect others from you in case you are infected, especially if you are not showing symptoms. It is recommended that the public wear face coverings, including homemade masks, to help prevent transmitting the virus to other people.
Vaccines against other diseases do not offer protection against SARS-CoV-2. This is a new virus that will need its own vaccine, and researchers are working on developing a safe and effective one.
There are simple things you can do to help keep yourself and others healthy. Wash your hands often with soap and water for at least 20 seconds, especially after blowing your nose, coughing, sneezing, going to the bathroom, and before eating or preparing food. When in public, wear a face mask that covers your mouth and nose. Avoid touching your eyes, nose, and mouth with unwashed hands. Stay home when you are sick. Cover your cough or sneeze with a tissue, then throw the tissue in the trash. Stay 6 feet apart from other people when you are out in public.
No. You can help stop COVID-19 by knowing the signs and symptoms, which can include:
- Shortness of breath
- Sore throat
- New loss of taste and/or smell
Seek medical attention immediately if you or someone you have been exposed to has emergency warning signs, including:
- Trouble breathing
- Persistent pain or pressure in the chest
- New confusion or not able to be woken up (from sleep)
- Bluish lips or face
This list of symptoms is NOT all inclusive and is being updated as new information becomes available. Visit the CDC’s Symptoms of Coronavirus & self-checker page for more information. Please consult your medical provider for any other symptoms that are severe or concerning.