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Protease Inhibitor

PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis for COVID-19

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 34
Awards & highlights

Study Summary

This trial will test the safety of a drug for mild-moderate COVID-19 in adults with severe renal impairment. 24 adults will take the drug for 5 days and have follow-up visits over 34 days.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 34
This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 34 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events and Serious Adverse Events
Number of Participants With Treatment Emergent AEs and SAEs (TEAEs)
Secondary outcome measures
Apparent Oral Clearance (CL/F) of PF-07321332 (nirmatrelvir)
Apparent Volume of Distribution (Vz/F) of PF-07321332 (nirmatrelvir)
Area Under the Curve from Time Zero to end of dosing interval (AUC 0-tau) PF-07321332 (nirmatrelvir)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysisExperimental Treatment1 Intervention
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
Group II: PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment not on hemodialysisExperimental Treatment1 Intervention
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,858 Total Patients Enrolled
67 Trials studying COVID-19
1,438,668 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,026 Total Patients Enrolled
49 Trials studying COVID-19
1,427,445 Patients Enrolled for COVID-19

Frequently Asked Questions

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

How many participants are currently being recruited for this clinical experiment?

"This clinical trial necessitates the enrolment of 24 participants who meet the pre-determined eligibility requirements. Patients can partake in this study from Northridge Kidney Center, located in California, or Fresenius Kidney Care Tampa #1130 situated near Meridian, Idaho."

Answered by AI

Are more participants being welcomed for this clinical trial?

"Evidently, this medical inquiry is in the process of recruiting participants. According to clinicaltrials.gov, it was first announced on September 7th 2022 and has been subject to revisions up until November 8th 2022."

Answered by AI

Is the combination of PF-07321332 (nirmatrelvir) with ritonavir particularly hazardous for individuals suffering from advanced renal disease and requiring hemodialysis?

"The safety of PF-07321332 (nirmatrelvir)/ritonavir for those experiencing severe renal impairment on hemodialysis is estimated to be 1, as there are limited data points available in regards to its efficacy and the protection it provides."

Answered by AI

What is the geographic distribution of sites running this clinical trial?

"The clinical trial is running at Northridge Kidney Center in California, Fresenius Kidney Care Tampa #1130 in Idaho and Fresenius Kidney Care-Meridian in Tennessee. Additionally, it is also available at 37 other medical centres across the country."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Grand Prairie Dialysis Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
2022. "A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05487040.
~6 spots leftby Apr 2025
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