Frequently Asked Questions About COVID-19 Clinical Studies
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.
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 in their everyday life. 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.
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 South Africa Health Products Regulatory Agency regulations on research, as well as international ethical standards and any country-specific requirements for the countries where our research is conducted.
A: No. 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 including South Africa. 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.
A: No. The vaccines and antibodies being tested through the CoVPN are preventive products. However, a small proportion of persons with COVID-19 may be allowed to participate. 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 have COVID-19.
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.
Here are some of the differences that enable us to speed up the search for vaccines and monoclonal antibodies against COVID-19. When scientists develop a vaccine or an antibody, they usually don’t start phase 2 studies until the phase 1 studies have finished. And they don’t start phase 3 studies until after the phase 2 studies have ended. In the search for a COVID-19 vaccine or antibody, we are overlapping some steps instead of doing them one after the other. We are also planning studies that are much larger, such as 30,000 participants instead of 4,000-5,000. Having more people means that study objectives can be met in a shorter period of time. Additionally, enrolling more participants from varied backgrounds enables us to ensure that the products we are testing will be safe for everyone.
Another big difference is the financial investment that has been made. These investment has made it possible for companies to manufacture larger amounts of their vaccines in advance without having to take all of the financial risks themselves. If a study shows that a vaccine is not effective, the vaccine doses that have been made can be destroyed, without causing the company to fail financially
A third factor is the commitment from regulatory groups like the South African Health Products Regulatory Authority (SAHPRA). They have very strict standards and regulations that must be followed to approve a vaccine or an antibody.
These changes to the process, investments, and regulatory standards mean that we will be able to find a preventive vaccine or antibody sooner, without compromising the safety of people who join the studies or the general public.
A: No, there is no way to guarantee whether you will get the vaccine or the placebo. All the studies will be blinded, which means that neither you nor the clinic staff will know who is getting which product. When someone decides to enroll, it will be a computer who makes a random assignment to the study product group or the placebo group, and only the pharmacist will know which product you get. These steps are necessary to ensure that no assumptions are made, and any immune responses or side effects are dealt with equitably, without favoritism.
A: The trials are enrolling people with a whole variety of health conditions, because we know that having underlying health conditions is one of the factors that puts people at risk for more severe COVID-19 illness. We can't comment on the specifics of any particular study, because each one is different. You can have a more specific conversation to address your particular concerns and health conditions with the research site or clinic staff.
A: We have clinics all over the country, click on this link for locations. Different clinics will be running each of the different studies that are coming up in the next several months. Some trials will also be done internationally. Additional sites are often added to a study to follow where COVID-19 outbreaks are happening or to better serve priority populations, and some sites may close early if they have enrolled their allotted number of participants.
The list of clinics that are participating can change frequently.
Interested in volunteering for a COVID-19 Prevention Clinical Trial? Select the button below for more information about the COVID-19 Clinical Trial and how you can become a volunteer.
A: No, you do not get paid for participating but we will reimburse you for your time, transport and inconvenience. The amount per visit varies depending on how long the visit is and the procedures that take place. The details about compensation will be explained when a person goes through the informed consent process at a local clinic to join a study.
A novel coronavirus is a new coronavirus that has not been previously identified in people. Coronavirus disease 2019 (COVID-19) is caused by the new virus called severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2). This is not the same as the coronaviruses that commonly circulate among humans 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 pre-existing health conditions are more at risk of severe illness.
COVID-19 can affect anyone, regardless of their race or ethnicity. However, data shows that its impact may be disproportionate largely due to social and structural factors that impact some communities more than others.
No. Antibiotics help stop bacterial infections and are not effective against viruses such as SARS-CoV-2.1
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. Generally it is recommended that everyone aged 6 months and over receive an influenza vaccine every year.
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.2 In fact, people infected with SARS-CoV-2 seem to be most infectious before they even show signs and symptoms.
A number of drugs are being reviewed as potential treatments, but nothing has yet been approved to treat or prevent COVID-19. Other treatments, such as Remdesivir and Dexamethasone, have shown some benefit in certain groups of people.3
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.4
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.
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.
SARS-CoV-2 can be transmitted in all areas, including hot/humid and cold climates.
While gargling with warm saltwater can make a sore throat feel better, it has no effect on SARS-CoV-2.5
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.2 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
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:
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.
The COVID-19 Prevention Network does not provide personal medical advice or diagnoses.
If you are experiencing a medical emergency, call 0800 029 999 and notify the operator if you think you might have COVID-19.
If you think you have been exposed to COVID-19 and develop a fever and symptoms such as a cough or difficulty breathing, call your healthcare provider immediately for medical advice.
World Health Organization, Coronavirus advice for the public: Myth busters
Centers for Disease Control and Prevention (CDC), Coronavirus COVID-20
Centers for Disease Control and Prevention (CDC), Key Facts
Johns Hopkins Bloomberg School of Public Health, COVID-19 Myths vs. Realities
Johns Hopkins Medicine, Coronavirus Disease 2019: Myth vs. Fact