We’re enrolling adults and adolescents who have tested positive for COVID-19 and are at an increased risk of severe illness.
We’re working closely with doctors to conduct a clinical trial for high-risk adults and adolescents with COVID-19 to determine if a potential antiviral treatment can safely and effectively help with recovery. This clinical trial will determine if a potential antiviral treatment can safely and effectively help with recovery without interacting with current medications or causing unwanted side effects.
By choosing to participate, you will receive care from a team of dedicated healthcare professionals while helping to advance what could be a breakthrough treatment for people around the world. So, thank you for taking the time to learn more.
Who may participate
This clinical trial is enrolling adolescents 12 years and older and adults 18 years and older who are at higher risk of developing severe COVID-19 or complications from COVID-19.
This study may be an option if you:
- Have COVID-19
- Developed symptoms within the last 5 days
- Have not received a COVID-19 vaccine in the last 4 months
- Have risk factors like;
o Older than 65
o Obesity with a BMI (Body Mass Index) over 30
o Current smoker
o Chronic lung disease
o Asthma requiring daily prescribed therapy
o Cardiovascular disease
o Type 1 or Type 2 diabetes mellitus
o Renal impairment (kidney disease)
o Sickle cell disease
o Have a condition or take medication that weakens your immune system
Condition
COVID-19
Age
Adults 18+ years and Adolescents 12+ years
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
Get started — See if you may be eligible
Answer a 5-minute questionnaire.
A first step as you consider this study is to answer a 5-minute online questionnaire about your health and medical history. If your answers show the study might be a good fit for you, you may choose to be referred to a study clinic that you select.
Speak with a study representative.
If you’re interested, you will then be asked to provide your contact information for a study representative to contact you and discuss the next steps.
Confirm your eligibility.
Your answers to these questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.
What to expect
If this clinical trial is a good fit for you and you agree to take part, you will have a 1 in 2 chance (50%) of receiving the study medicine or placebo. The placebo looks just like the study medicine but does not contain any active ingredients.
This clinical trial will last for around 24 weeks, and you will have 12 appointments (some appointments may be by telephone).
You will take the study medicine or placebo by mouth (pill) twice a day for 5 days (10 doses total). Whether you receive the study medicine or placebo, you may still take a standard of care medicine for COVID-19 while in the clinical trial. This means you will be cared for using the current best practices determined by your study doctor.
Length of study treatment
5-6 days (10 doses)
Number of study visits
About 12
Long-term follow up
About 6 months (24 weeks)
About the study treatment
The study medicine is an antiviral (pill that is taken by mouth) and has been designed to prevent coronavirus from multiplying in cells. It may potentially decrease the risk of developing severe COVID-19 or complications from COVID-19 and we are conducting this clinical trial to find out more.
Frequently asked questions
Coronaviruses comprise a large family of viruses, some of which cause respiratory illnesses in humans, ranging from common colds to more severe conditions. The coronavirus involved in the outbreak that began in 2019 was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease it causes was named “coronavirus disease 2019” or “COVID-19.”
Immunocompromised or high-risk refers to people that have weakened immune systems. These participants may already be on other medications for pre-existing conditions. Examples of people who may be immunocompromised include those with T or B cell immunodeficiencies, or those taking chemotherapy, biologics or corticosteroids.
There are several factors that may make someone high risk including:
- Body Mass Index over 30
- Current smoker
- Chronic lung disease
- Asthma, requiring daily prescribed therapy
- Cardiovascular disease
- Type 1 or Type 2 diabetes mellitus
- Mild to moderate renal impairment
- Sickle cell disease.
- Have a condition or take medication that weakens your immune system
