COVID-19 Clinical Trial
Official title:
A PHASE 1, OPEN-LABEL, NON-RANDOMIZED STUDY TO INVESTIGATE THE SAFETY AND PK FOLLOWING MULTIPLE ORAL DOSES OF PF-07321332 (NIRMATRELVIR)/RITONAVIR IN ADULT PARTICIPANTS WITH COVID-19 AND SEVERE RENAL IMPAIRMENT EITHER ON HEMODIALYSIS OR NOT ON HEMODIALYSIS
| Verified date | May 2024 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to learn about the side effects (safety) of the study medicine PF-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate COVID-19 infection in adults with severe renal impairment. The study will also look at the amounts of study drug in your blood. There will be 24 participants in this study; 12 of them will have severe renal impairment and not be on hemodialysis and 12 of them will be on hemodialysis. All participants in this study will take PF-07321332 (nirmatrelvir)/ritonavir by mouth for 5 days. During this time, they will have to collect blood samples to measure the study drug levels in their blood. After taking the study drug for 5 days, the participants will have follow-up visits for about another 28 days for a total of about 34 days in the study. The study team will check how each participant is doing during regular visits at the study clinic.
| Status | Terminated |
| Enrollment | 15 |
| Est. completion date | July 11, 2023 |
| Est. primary completion date | July 11, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Covid-19 infection - Severe kidney disease (on hemodialysis or not on hemodialysis) Exclusion Criteria: - Hospitalized - Take medications that are not allowed - Renal transplant patients - HIV infection This is not a complete list. Other inclusion and exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Arlington Nephrology | Arlington | Texas |
| United States | South Arlington Dialysis Center | Arlington | Texas |
| United States | Fresenius Kidney Care-Boise | Boise | Idaho |
| United States | Fresenius Kidney Care- Caldwell | Caldwell | Idaho |
| United States | University of Virginia Health System | Charlottesville | Virginia |
| United States | Swedish Covenant Hospital | Chicago | Illinois |
| United States | DaVita Evanston Renal Center | Evanston | Illinois |
| United States | NorthShore University HealthSystem - Evanston Hospital | Evanston | Illinois |
| United States | Fresenius Kidney Care Ft Lauderdale #2036 | Fort Lauderdale | Florida |
| United States | DaVita Glen Dialysis | Glenview | Illinois |
| United States | NorthShore University HealthSystem - Glenbrook Hospital | Glenview | Illinois |
| United States | Amicis Research Center | Granada Hills | California |
| United States | Amicis Research Center - Granada Hills | Granada Hills | California |
| United States | Grand Prairie Dialysis Center | Grand Prairie | Texas |
| United States | Fresenius Kidney Care / Roane County #2829 | Harriman | Tennessee |
| United States | NorthShore University HealthSystem - Highland Park Hospital | Highland Park | Illinois |
| United States | Apogee Clinical Research, LLC | Huntsville | Alabama |
| United States | Fresenius Kidney Care Chase | Huntsville | Alabama |
| United States | Fresenius Kidney Care Endeavour | Huntsville | Alabama |
| United States | Fresenius Kidney Care Huntsville | Huntsville | Alabama |
| United States | Fresenius Kidney Care Parkway | Huntsville | Alabama |
| United States | Fresenius Kidney Care Rocket City | Huntsville | Alabama |
| United States | Nephrology Consultants | Huntsville | Alabama |
| United States | DaVita Inglewood Dialysis | Inglewood | California |
| United States | Fresenius Kidney Care / Cedar Bluff #6942 | Knoxville | Tennessee |
| United States | Fresenius Kidney Care / Fort Sanders #1597 | Knoxville | Tennessee |
| United States | Knoxville Kidney Center, PLLC | Knoxville | Tennessee |
| United States | South Florida Research Institute | Lauderdale Lakes | Florida |
| United States | Fresenius Kidney Care Florida Kidney Center #1095 | Lauderhill | Florida |
| United States | Fresenius Kidney Care-Meridian | Meridian | Idaho |
| United States | Boise Kidney & Hypertension Institute, PLLC | Nampa | Idaho |
| United States | Liberty Dialysis- Nampa | Nampa | Idaho |
| United States | Northridge Kidney Center | Northridge | California |
| United States | Clinnova Research - Redondo Beach | Redondo Beach | California |
| United States | GCP Research, Global Clinical professionals | Saint Petersburg | Florida |
| United States | Santa Clarita Dialysis | Santa Clarita | California |
| United States | NorthShore Immediate Care Center - Skokie at Old Orchard Woods | Skokie | Illinois |
| United States | NorthShore University HealthSystem - Clinical Trials Center | Skokie | Illinois |
| United States | NorthShore University HealthSystem - Skokie Hospital | Skokie | Illinois |
| United States | laurel Canyon Dialysis | Sun Valley | California |
| United States | Fresenius Kidney Care Tamarac-JV #6606 | Tamarac | Florida |
| United States | Fresenius Kidney Care Carrollwood #1805 | Tampa | Florida |
| United States | Fresenius Kidney Care Hillsborough #100706 | Tampa | Florida |
| United States | Fresenius Kidney Care Tampa #1130 | Tampa | Florida |
| United States | Fresenius Kidney Care Town and Country #100474 | Tampa | Florida |
| United States | Fresenius Kidney Care Ybor City #1863 | Tampa | Florida |
| United States | Genesis Clinical Research, LLC | Tampa | Florida |
| United States | Desert Cities Dialysis - Hesperia | Victorville | California |
| United States | Desert Cities Diaylsis | Victorville | California |
| United States | Brookview Hills Research Associates | Winston-Salem | North Carolina |
| United States | Northside Dialysis Center | Winston-Salem | North Carolina |
| United States | Piedmont Dialysis Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent AEs and SAEs (TEAEs) | Through Day 34 | ||
| Primary | Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events and Serious Adverse Events | Through Day 34 | ||
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-07321332 (nirmatrelvir) | Treatment Day 1 to Day 5 | ||
| Secondary | Apparent Oral Clearance (CL/F) of PF-07321332 (nirmatrelvir) | Treatment Day 1 to Day 5 | ||
| Secondary | Apparent Volume of Distribution (Vz/F) of PF-07321332 (nirmatrelvir) | Treatment Day 1 to Day 5 | ||
| Secondary | Area Under the Curve from Time Zero to end of dosing interval (AUC 0-tau) PF-07321332 (nirmatrelvir) | Treatment Day 1 to Day 5 | ||
| Secondary | Plasma Decay Half-Life (t1/2) of PF-07321332 (nirmatrelvir) | Treatment Day 1 to Day 5 | ||
| Secondary | Pre-dose Plasma Concentration (Ctrough) of PF-07321332 (nirmatrelvir) | Treatment Day 1 to Day 5 | ||
| Secondary | Dialyzer Clearance (CLd) (nirmatrelvir) | 0 Hour to approximately 4 Hours | ||
| Secondary | Fraction of drug removed during dialysis (Fd) (nirmatrelvir) | 0 Hour to approximately 4 Hours |
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