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Protease Inhibitor

Nirmatrelvir + Ritonavir for COVID-19 in Pregnancy

Phase 1
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Current use of any medications that are highly dependent on CYP3A4 for clearance, and which are contraindicated in combination with nirmatrelvir/ritonavir
Has received or is expected to receive monoclonal antibody treatment, convalescent COVID-19 plasma, or anti-viral treatment (eg, molnupiravir) for the current SARSCoV-2 infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is seeking to learn about the safety and how study medicine is eliminated from the body for pregnant women with mild to moderate COVID-19 compared to non-pregnant women with mild to moderate COVID-19.

Who is the study for?
This trial is for pregnant women in their second or third trimester with mild to moderate COVID-19, and non-pregnant individuals with the same condition. Participants should be expecting a healthy baby, not need hospitalization, have no major health risks that could affect the study or pregnancy outcome, and not be on certain medications.
What is being tested?
The trial studies Paxlovid (nirmatrelvir plus ritonavir) in pregnant versus non-pregnant women with COVID-19. It aims to understand how this medication is processed by the body and its safety profile over a period of up to 6 months.
What are the potential side effects?
While specific side effects are not listed here, participants will report any they experience while taking Paxlovid. The drug's known side effects include taste disturbances, diarrhea, high blood pressure and muscle aches.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
You are currently taking medications that are not safe to use with nirmatrelvir/ritonavir.
Select...
You have been treated or will be treated with specific medications for your current COVID-19 infection.
Select...
You have moderate to severe kidney problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 2 trial • 436 Patients • NCT05567952
10%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nirmatrelvir 300 mg + Ritonavir 100 mg
Placebo + Ritonavir 100 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
Non-pregnant women
Group II: Cohort 2Experimental Treatment2 Interventions
Pregnant women in their third trimester
Group III: Cohort 1Experimental Treatment2 Interventions
Pregnant women in their second trimester
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nirmatrelvir
2022
Completed Phase 2
~450
ritonavir
2011
Completed Phase 4
~2000

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,660 Previous Clinical Trials
17,877,278 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,545 Previous Clinical Trials
14,918,443 Total Patients Enrolled

Media Library

Nirmatrelvir (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05386472 — Phase 1
Coronavirus Research Study Groups: Cohort 1, Cohort 2, Cohort 3
Coronavirus Clinical Trial 2023: Nirmatrelvir Highlights & Side Effects. Trial Name: NCT05386472 — Phase 1
Nirmatrelvir (Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05386472 — Phase 1
Coronavirus Patient Testimony for trial: Trial Name: NCT05386472 — Phase 1
~6 spots leftby Apr 2025
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