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Pregnant Women With Recently Diagnosed, Symptomatic COVID-19

A COVID-19 clinical research study is underway to compare the pharmacokinetics (how a drug is absorbed, distributed, and processed in the body) and tolerability of PAXLOVID™ in pregnant versus non-pregnant women ages 18 to 50 with mild-to-moderate symptomatic COVID-19.

Now Enrolling

To connect with a member of the study, call 800-887-7002 and provide NCT05386472.

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About The Study

This study is evaluating how the COVID-19 oral treatment PAXLOVID™ (a combination of nirmatrelvir and ritonavir) is absorbed and used in the body, and if it is tolerable for women who are pregnant. If you have recently been diagnosed with COVID-19, please call 800-887-7002 to see if this study may be right for you.

Who May Participate

Joining a clinical trial is an important and personal decision. Thank you for considering this study.

This study may be an option for women who are 18 to 50 years old and meet the requirements below:

  • Tested positive for COVID-19 within the last 5 days
  • Currently have at least 1 symptom related to COVID-19 in the last 5 days
  • In the 2nd or 3rd trimester of pregnancy (14 weeks to 34 weeks and 6 days)

Note: There are other requirements to participate in this study. A study team member will help determine if this study is right for you.

To connect with a member of the study, call 800-887-7002.

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What to Expect

All participants will receive 10 doses of PAXLOVID. You will take the first dose on the same day you enter the study or within 2 days after. You will then take the following 9 doses at home twice daily over 5 or 6 days. You will track your doses of PAXLOVID in an electronic diary (eDiary). You will also be asked to collect blood samples to measure the amount of PAXLOVID in your blood. The study team will provide instructions and help you with this.

If you are pregnant, you will be in the study for about 36 days or until you deliver your baby, whichever comes later. After Day 36, you will not have additional study visits until you deliver your baby. If you are not pregnant, you will be in the study for about 36 days.

Throughout the study, you will need to attend at least 8 appointments (or 7, if not pregnant) so the study team can monitor how you are doing. At least 3 appointments (or 2, if not pregnant) will be in-person.

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