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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth through 24 hours after birth or until study day 34 (whichever is later)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and at birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent Oral Clearance (CL/F)
Apparent Volume of Distribution (Vz/F)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
+5 more
Secondary outcome measures
Body length of newborn infants
Body weight of newborn infants
Gestational age of newborn infants
+16 more

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
4,575 Previous Clinical Trials
10,923,053 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,482 Previous Clinical Trials
8,099,314 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial currently open?

"Per data hosted on clinicaltrials.gov, this medical study is recruiting participants as of the present time. It was initially posted on June 22nd 2022 and underwent its last edit November 8th 2022."

Answered by AI

What criteria must participants meet to be accepted into this scientific investigation?

"This clinical trial is seeking 45 individuals between 18 and 50 years of age who have been diagnosed with Covid-19. They must meet the following criteria: Mild to moderate COVID-19 symptoms confirmed in a specimen collected within 5 days prior to enrollment, presence of at least one symptom on the day of enrolment, expecting single baby depending on whether they are in their second or third trimester gestational age; and lastly being judged as healthy by medical history review, physical examination, and general judgement."

Answered by AI

Are there numerous locations in Canada that have implemented this research study?

"This trial is currently recruiting patients from a total of 19 sites, among them Clinical Research Prime Rexburg in Rexburg, University of Alabama at Birmingham Women & Infant Center in Birmingham and Boeson Research (GTF) in Los Angeles."

Answered by AI

What is the upper limit for particpants in this trial?

"Affirmative. The information on clinicaltrials.gov reveals that this medical study is currently enrolling participants, as the original post was made June 22nd 2022 and recent updates were applied November 8th of the same year. Nineteen different sites are recruiting for a total of 45 patients."

Answered by AI

Has nirmatrelvir been granted authorization from the FDA?

"The tentative safety rating of nirmatrelvir is 1, as this Phase 1 trial has only provided limited evidence to support its efficacy and security."

Answered by AI

Does this study accommodate individuals older than fifty years of age?

"To participate in this medical trial, patients must be between 18 to 50 years old. Separately, 137 studies are open for minors and 899 research projects are designed for seniors over the age of 65."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Texas
What site did they apply to?
St. David's Medical Center
Abby's Research institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I don't have it but would try prevention methods.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
2022. "A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05386472.
All > Covid 19 > Coronavirus
~13 spots leftby Feb 2025
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