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COVID-19 Clinical Trials

COVID-19
 

As U.S. scientists ramp up a national effort to evaluate COVID-19 vaccine candidates at clinical trial sites across the country, researchers at Saint Louis University’s Center for Vaccine Development have been tapped to join the historic effort to find a COVID-19 vaccine that can prevent the illness. This month, we will begin enrolling 1000 participants in the first COVID-19 vaccine trial and several additional trials are expected to begin later this year. Researchers say it will be critically important to enroll participants who are likely to be exposed to COVID-19 or those at risk for severe disease from COVID-19, including participants over age 65.

Interested in Volunteering for a COVID-19 Prevention Clinical Study?

The purpose of this screening registry is to create a list of potential volunteers who want to take part in current or future COVID-19 prevention clinical trials. You must be 18 years or older to participate. Participation involves completing a short online survey that includes some personal questions. Your participation is voluntary.

COVID-19 Screening Registry

Frequently Asked Questions About COVID-19 Clinical Studies

Q: Does a vaccine or antibody against SARS-CoV-2 or COVID-19 already exist?
A: There is no licensed vaccine or antibody 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.
Q: Will study participants be given SARS-CoV-2 or COVID-19 as part of the study? 
A: No. That type of study design is known as a challenge study. Instead, we are using a design known as “randomized, blinded, placebo-controlled” studies. We will enroll people who are more likely to be exposed to SARS-CoV-2 infection and COVID-19 illness. 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. 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. 
 Q: Is joining a COVID-19 vaccine or antibody study like being a guinea pig?
A: Unlike guinea pigs, people can say yes or no about joining a study. All study volunteers must 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. The COVID-19 Prevention Network (CoVPN) takes great care to make sure people understand the study fully before they decide whether or not to join. All CoVPN studies follow US federal regulations on research, as well as international ethical standards and any country-specific requirements for the countries where our research is conducted. 
 Q: Are Western scientists unfairly using people in developing countries to test COVID-19 vaccines?

A: In order to find a vaccine or antibody 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 the CoVPN works 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 we follow the same procedures and international standards no matter where the study takes place.

 
 Q: Does a person have to be infected with SARS-CoV-2 to be in a COVID-19 vaccine or antibody study?
A: No. The vaccines and antibodies being tested by the CoVPN are preventive products. They must be tested on volunteers who do not have COVID-19, because our goal is to keep people healthy. There are other research groups that are conducting studies of treatments that might be used for people who already have COVID-19. 
Q: Are vaccines safe? 
A: 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. 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.
Q: Do study participants get paid? 
A: Yes, people who join a study get compensated for their time and inconvenience. The amount per visit varies depending on how long the visit is and the procedures that take place. The amount also varies from city to city, because the cost of living is different between large metropolitan areas compared to smaller towns and rural areas. The details about compensation will be explained when a person goes through the informed consent process at a local clinic to join a study. 

Frequently Asked Questions About COVID-19 Disease

Q: Does COVID-19 only affect older people?

A: 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 pre-existing health conditions are more at risk of severe illness. 

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Q: Does COVID-19 only affect people from certain racial or ethnic groups?

A: COVID-19 can affect anyone, regardless of their race or ethnicity. However, data show that it is disproportionately impacting Black, Latinx, and Native American populations. This is largely due to social and structural factors that impact some communities more than others. These factors include poverty, poor housing conditions, challenges with accessing medical care, and limited resources, among others.

Q: Can antibiotics prevent and treat SARS-CoV-2?

A: No. Antibiotics help stop bacterial infections and are not effective against viruses such as SARS-CoV-2.

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Q: Is COVID-19 like the seasonal flu?

A: No. Some people who do get SARS-CoV-2, the virus that causes COVID-19, experience flu-like symptoms. COVID-19 currently has a higher death rate than the flu and appears to be more contagious than the flu. We do not know yet whether COVID-19 will change with the seasons like influenza. In the US, the CDC recommends that everyone aged 6 months and over receive an influenza vaccine every year.

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Q: Can you give SARS-CoV-2 to someone even if you do not have symptoms?

A: Yes. Scientists have found that people who have SARS-CoV-2 and have no symptoms (i.e., asymptomatic) can still pass along SARS-CoV-2 to others. In fact, people infected with SARS-CoV-2 seem to be most infectious before they even show signs and symptoms.

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Q: Is there currently an FDA-approved treatment for COVID-19?

A: 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.

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Q: Can a face mask protect you from SARS-CoV-2?

A: 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 cloth masks, including homemade masks, to help prevent transmitting the virus to other people.

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Q: Can SARS-CoV-2 be transmitted through mosquito bites?

A: To date there is no information or evidence to suggest that SARS-CoV-2 can be transmitted by mosquitos. This disease is a respiratory virus spread primarily through droplets when an infected person coughs, sneezes or has discharge from the nose.

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Q: Can vaccines against pneumonia provide protection against SARS-CoV-2?

A: 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.

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Q: Can SARS-CoV-2 spread in hot and cold climates?

A: SARS-CoV-2 can be transmitted in all areas, including hot/humid and cold climates.

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Q: Does drinking a lot of water and gargling with warm salt water or vinegar eliminate the virus?

A: While gargling with warm saltwater can make a sore throat feel better, it has no effect on SARS-CoV-2.

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Q: Is there anything I can do to decrease my chances of getting SARS-CoV-2?

A: 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 cloth 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.

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Q: Are a cough or runny nose the only symptoms associated with SARS-CoV-2?

A: No. You can help stop COVID-19 by knowing the signs and symptoms, which can include:

  • Fever

  • Cough

  • Shortness of breath

  • Chills

  • 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. Please consult your medical provider for any other symptoms that are severe or concerning.

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Further Information on SARS-CoV-2 and COVID-19

What we know about the virus, SARS-CoV-2, and the disease, COVID-19, is constantly changing. To stay up to date on the most current information, we recommend that you visit the following websites for reliable and accurate information:

Information about how the epidemic is impacting the world (mathematical modeling):