A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized
NCT ID: NCT05799495
Last Updated: 2024-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2023-05-23
2023-10-11
Brief Summary
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The study is seeking for participants who:
* are 18 years of age or older at the time of entering the study.
* have a positive rapid antigen test within 48 hours before entering the study. Rapid antigen test is a test done to confirm the presence of a specific virus in the body.
* have onset of signs or symptoms of COVID-19 within 5 days before entering the study.
* have at least 1 of the specified signs or symptoms of COVID-19 present on the day of entering the study.
Around 228 participants with a confirmed case of COVID 19 are planned to be taken into the study. Participants will be randomly grouped to receive PF-07817883. Three groups will receive 100, 300, 600mg of PF-07817883 and one of the groups will receive placebo (a pill that doesn't have any medicines) orally every 12 hours for 5 days.
The study is going to last up to 5 weeks. This includes the initial period of selecting participants, participants receiving the medicine or the placebo and then a 4-week follow-up period after giving the participants the last medicine.
The study team will monitor how each participant is doing with the study treatment during the study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1: low dose
PF-07817883
Arm 1: low dose Arm 2: medium dose Arm 3: high dose
Arm 2: medium dose
PF-07817883
Arm 1: low dose Arm 2: medium dose Arm 3: high dose
Arm 3: high dose
PF-07817883
Arm 1: low dose Arm 2: medium dose Arm 3: high dose
Arm 4: Placebo
Placebo
Placebo
Interventions
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PF-07817883
Arm 1: low dose Arm 2: medium dose Arm 3: high dose
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* WOCBP may be enrolled.
* All fertile participants must agree to use a highly effective method of contraception.
2. Confirmed SARS-CoV-2 infection as determined by RAT in NP specimen collected within 48 hours prior to randomization. Investigator sites will use test kits that are authorized for use in this study and the test result must be available to confirm eligibility.
3. Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified signs/symptoms attributable to COVID-19 present on the day of randomization.
Exclusion Criteria
2. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh Class B or Class C, or acute liver failure.
3. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator.
4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
5. Immunocompromised with ≥1 of the following:
1. Solid organ (eg, liver, heart, lung or kidney) transplant recipient who is receiving immunosuppressive therapy.
2. Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or receiving immunosuppressive therapy.
3. Moderate or severe primary immunodeficiency (eg, DiGeorge syndrome, Wiskott-Aldrich syndrome).
4. Use of at least 1 of the following immune-weakening medications:
iii. Has received corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days within 30 days prior to study entry.
iv. Active treatment causing significant immunosuppression, including alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents, TNF blockers, or other highly immunosuppressive drugs such as biologics.
5. Hematological malignancy (including leukemia, lymphoma and myeloma) or active immunosuppressive treatment for solid tumor.
6. HIV infection with CD4 cell count \<200 mm3 from known medical history within the past 6 months of screening.
6. known severe renal impairment (eGFR of \<30 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula12).
7. Oxygen saturation of \<92% on room air obtained at rest within 24h prior to randomization.
8. Has received or is expected to receive any other antiviral for the treatment of COVID 19, including remdesivir, PAXLOVID, molnupiravir, mAb treatment (within 30 days or 5 half-lives \[whichever is longer\] prior to screening) or received convalescent COVID-19 plasma within 12 months.
9. Expected to receive any dose of a SARS-CoV-2 vaccine within 14 days of randomization or during the study.
10. Current or previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.
11. Known prior participation in this trial
12. Known history of any of the following abnormalities in clinical laboratory tests (within past 6 months of the screening visit):
* T bili ≥2 × ULN (except for Gilbert's syndrome)
* AST or ALT ≥2.5 × ULN
* Abs neutrophil count \<1000/mm3.
18 Years
64 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Cullman Clinical Trials
Cullman, Alabama, United States
ClinMed
Phoenix, Arizona, United States
Epic Medical Research - Surprise
Surprise, Arizona, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Franco Felizarta, Md
Bakersfield, California, United States
Hope Clinical Research, Inc.
Canoga Park, California, United States
Velocity Clinical Research, Chula Vista
Chula Vista, California, United States
Benchmark Research
Colton, California, United States
Ascada Health PC dba Ascada Research
Fullerton, California, United States
Long Beach Clinical Trials
Long Beach, California, United States
Marvel Clinical Research - Santa Ana
Santa Ana, California, United States
Herco Medical and Research Center Inc
Coral Gables, Florida, United States
Advance Clinical Research Group
Cutler Bay, Florida, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States
Qway Research LLC
Hialeah, Florida, United States
Unlimited Medical Research Group LLC
Hialeah Gardens, Florida, United States
Angels Clinical Research Institute
Miami, Florida, United States
South Florida Research Center
Miami, Florida, United States
USPA Advance Concept Medical Research Group
Miami, Florida, United States
Bio-Medical Research LLC
Miami, Florida, United States
Coral Research Clinic Corp
Miami, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
DBC Research USA
Pembroke Pines, Florida, United States
GCP Research, Global Clinical professionals
St. Petersburg, Florida, United States
Javara - Privia Medical Group Georgia - Albany
Albany, Georgia, United States
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, United States
Centricity Research Columbus Acute Care
Columbus, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Snake River Research
Idaho Falls, Idaho, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Mercury Street Medical Group, PLLC
Butte, Montana, United States
Henderson Clinical Trials
Henderson, Nevada, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Wellnow Urgent Care and Research
Cincinnati, Ohio, United States
Remington-Davis, Inc
Columbus, Ohio, United States
WellNow Urgent Care & Research
Dayton, Ohio, United States
Kur Research @ Bon Secours Mercy Health, Inc - Urgent Care Easley
Easley, South Carolina, United States
Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
Conroe, Texas, United States
Javara - Privia Medical Group Gulf Coast - Cypress
Cypress, Texas, United States
DFW Clinical Research
Dallas, Texas, United States
Proactive Clinical Research LLC
Edinburg, Texas, United States
Next Level Urgent Care
Houston, Texas, United States
Laguna Clinical Research
Laredo, Texas, United States
Epic Clinical Research
Lewisville, Texas, United States
BFHC Research, LLC
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
Shenandoah, Texas, United States
Javara - Privia Medical Group North Texas - Stephenville
Stephenville, Texas, United States
Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
The Woodlands, Texas, United States
Eastside Research Associates
Redmond, Washington, United States
Countries
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References
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Mortezavi M, Sloan A, Singh RSP, Chen LF, Kim JH, Shojaee N, Toussi SS, Prybylski J, Baniecki ML, Bergman A, Banerjee A, Allerton C, Alami NN. Virologic Response and Safety of Ibuzatrelvir, A Novel SARS-CoV-2 Antiviral, in Adults With COVID-19. Clin Infect Dis. 2025 Mar 17;80(3):673-680. doi: 10.1093/cid/ciae529.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2022-002871-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506667-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
C5091003
Identifier Type: -
Identifier Source: org_study_id
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