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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.

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Who is running the clinical trial?

PfizerLead Sponsor
4,582 Previous Clinical Trials
14,634,782 Total Patients Enrolled
67 Trials studying COVID-19
1,438,369 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,487 Previous Clinical Trials
11,811,657 Total Patients Enrolled
50 Trials studying COVID-19
1,427,190 Patients Enrolled for COVID-19
~5 spots leftby Jun 2025
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