The COVID antiviral clinical trials are committed to finding potential treatment options for people recently diagnosed with symptomatic COVID-19.
These clinical trials are researching if an oral study medicine called PAXLOVIDTM reduces the length of time and/or severity of illness for people who have developed symptoms and are recently diagnosed with COVID-19. Participating in a study is an important and personal decision. We want you to know that we will be with you every step of the way.
Participating in these studies
Each COVID antiviral study will have its own unique requirements for who may participate called eligibility criteria.
The requirements may include a certain age or health condition as well as having at least one symptom of COVID-19.
You can talk with the study doctor to find out which study may be right for you. Joining a clinical trial is an important decision for your family and we thank you for your interest.
Male or Female
This information is a summary of the eligibility criteria across the studies in this program. Each study will have its own unique requirements for who may participate (eligibility criteria). To learn more about the requirements for a study that is actively recruiting, visit the study’s webpage below. Only the research study staff can determine if you qualify to enroll in the study.
COVID-19 Antiviral Treatment Clinical Trials
A Phase 2/3 study assessing how PAXLOVIDTM is changed and eliminated from the body, as well as its safety and effectiveness in children and teens who are at increased risk of severe illness.
A Phase 1 study assessing how PAXLOVIDTM is changed and eliminated from the body, as well as its safety in adults with severe renal impairment.
A Phase 2 study assessing the effectiveness of different courses of PAXLOVIDTM in immunocompromised adults and adolescents.
A Phase 2 study assessing the effectiveness of an additional course of PAXLOVIDTM in adults and adolescents with COVID-19 rebound.
COVID-19 is caused by a virus called the SARS-CoV-2 coronavirus. You can get COVID-19 through close contact with another person who has the virus. COVID-19 illnesses have ranged from mild to severe, including illness resulting in hospitalization or death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse.
Older people and people of all ages with medical conditions like heart disease, lung disease, and diabetes, for example, seem to be at higher risk of severe COVID-19 illness.
About the study medicine
The COVID-19 antiviral studies are evaluating the safety and effectiveness of the study medicine, PAXLOVIDTM, which is given orally. PAXLOVIDTM is a combination of the medicines nirmatrelvir and ritonavir. Nirmatrelvir is intended to reduce SARS-CoV-2 virus, thereby reducing the duration and severity of symptoms and the risk of hospitalization and death in SARS-CoV-2 infected patients. Ritonavir is a medication to boost the absorption of the study drug, nirmatrelvir.
PAXLOVIDTM was studied in a previous clinical trial of non-hospitalized adults with symptomatic COVID-19 who had at least 1 risk factor for progressing to severe COVID-19. The results from that study showed that participants who received PAXLOVIDTM were less likely to be hospitalized or die from COVID-19 compared to participants who received a placebo (medicine with no active ingredient).
PAXLOVIDTM has not been approved but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The emergency use of PAXLOVIDTM is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner.
About the study medicine
The importance of representation
Diversity among study participants is important to understand whether potential treatments work in different people. Race, ethnicity, age, and sex can all impact how different people respond to the same treatment.
When groups of people aren’t well represented in research, we cannot know if the study medicine may work properly for the people it is trying to help. When you take part in a study, you’re helping to represent both your community and all people who are affected by COVID-19.