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

NCT05799495 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: C50910032022-002871-122023-506667-34-00
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 53

Brief Summary

The purpose of the study is to understand the effects and safety of PF-07817883 treatment. The study wants to know how PF-07817883 treatment lowers the level of the virus that causes COVID 19. To understand that samples are collected from adult participants who have the symptoms of COVID 19 but are not hospitalized. 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.

Conditions

SARS-CoV-2 Infection

Keywords

COVID-19; SARS COVID-19

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Logarithm Base 10 (Log10) Transformed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribo Nucleic Acid (RNA) Level on Day 5

  Change from baseline in SARS-CoV-2 RNA level at Day 5 was analyzed using Mixed Effects Repeated Measures (MMRM) model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (\<=3 versus \[vs.\] \>3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4\*log10 copies/milliliter, missing, or not detected.

  Baseline (Day 1), Day 5

Secondary Outcomes (6)

• Change From Baseline in Log10 Transformed SARS-CoV-2 RNA Level on Days 3, 10 and 14

  Baseline (Day 1), Day 3, Day 10 and Day 14

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  From start of study intervention up to 28 days after last dose of study intervention (up to 33 days)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuations

  From start of study intervention up to 28 days after last dose of study intervention (up to 33 days)

• Number of Participants With Laboratory Test Abnormalities

  From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).

• Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities

  From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).

Study Arms (4)

Arm 1: low dose

EXPERIMENTAL

Drug: PF-07817883

Arm 2: medium dose

EXPERIMENTAL

Drug: PF-07817883

Arm 3: high dose

EXPERIMENTAL

Drug: PF-07817883

Arm 4: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PF-07817883 DRUG

Arm 1: low dose Arm 2: medium dose Arm 3: high dose

Arm 1: low dose; Arm 2: medium dose; Arm 3: high dose

Placebo DRUG

Placebo

Arm 4: Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants ≥18 to \<65 years of age at the time of the Screening Visit.
• WOCBP may be enrolled.
• All fertile participants must agree to use a highly effective method of contraception.
• 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.
• 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.

You may not qualify if:

• Current need for hospitalization or anticipated need for hospitalization within 24h after randomization in the clinical opinion of the site investigator.
• 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.
• History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator.
• Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
• Immunocompromised with ≥1 of the following:
• Solid organ (eg, liver, heart, lung or kidney) transplant recipient who is receiving immunosuppressive therapy.
• Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or receiving immunosuppressive therapy.
• Moderate or severe primary immunodeficiency (eg, DiGeorge syndrome, Wiskott-Aldrich syndrome).
• 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.
• Hematological malignancy (including leukemia, lymphoma and myeloma) or active immunosuppressive treatment for solid tumor.
• HIV infection with CD4 cell count \<200 mm3 from known medical history within the past 6 months of screening.
• 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).
• Oxygen saturation of \<92% on room air obtained at rest within 24h prior to randomization.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (53)

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

ClinMed

Phoenix, Arizona, 85004, United States

Location

Epic Medical Research - Surprise

Surprise, Arizona, 85378, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Franco Felizarta, Md

Bakersfield, California, 93301, United States

Location

Hope Clinical Research, Inc.

Canoga Park, California, 91303, United States

Location

Velocity Clinical Research, Chula Vista

Chula Vista, California, 91911, United States

Location

Benchmark Research

Colton, California, 92324, United States

Location

Ascada Health PC dba Ascada Research

Fullerton, California, 92835, United States

Location

Long Beach Clinical Trials

Long Beach, California, 90806, United States

Location

Marvel Clinical Research - Santa Ana

Santa Ana, California, 92704, United States

Location

Herco Medical and Research Center Inc

Coral Gables, Florida, 33134, United States

Location

Advance Clinical Research Group

Cutler Bay, Florida, 33157, United States

Location

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, 33308, United States

Location

Qway Research LLC

Hialeah, Florida, 33010, United States

Location

Unlimited Medical Research Group LLC

Hialeah Gardens, Florida, 33018, United States

Location

Angels Clinical Research Institute

Miami, Florida, 33122, United States

Location

South Florida Research Center

Miami, Florida, 33135, United States

Location

USPA Advance Concept Medical Research Group

Miami, Florida, 33143, United States

Location

Bio-Medical Research LLC

Miami, Florida, 33144, United States

Location

Coral Research Clinic Corp

Miami, Florida, 33186, United States

Location

Palm Springs Community Health Center

Miami Lakes, Florida, 33014, United States

Location

DBC Research USA

Pembroke Pines, Florida, 33029, United States

Location

GCP Research, Global Clinical professionals

St. Petersburg, Florida, 33705, United States

Location

Javara - Privia Medical Group Georgia - Albany

Albany, Georgia, 31707, United States

Location

Centricity Research Columbus Georgia Multispecialty

Columbus, Georgia, 31904, United States

Location

Centricity Research Columbus Acute Care

Columbus, Georgia, 31909, United States

Location

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

Location

Snake River Research

Idaho Falls, Idaho, 83404, United States

Location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

Henderson Clinical Trials

Henderson, Nevada, 89052, United States

Location

Excel Clinical Research, LLC

Las Vegas, Nevada, 89109, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Accellacare - Wilmington

Wilmington, North Carolina, 28401, United States

Location

Wellnow Urgent Care and Research

Cincinnati, Ohio, 45215, United States

Location

Remington-Davis, Inc

Columbus, Ohio, 43215, United States

Location

WellNow Urgent Care & Research

Dayton, Ohio, 45424, United States

Location

Kur Research @ Bon Secours Mercy Health, Inc - Urgent Care Easley

Easley, South Carolina, 29640, United States

Location

Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW

Conroe, Texas, 77384, United States

Location

Javara - Privia Medical Group Gulf Coast - Cypress

Cypress, Texas, 77433, United States

Location

DFW Clinical Research

Dallas, Texas, 75234, United States

Location

Proactive Clinical Research LLC

Edinburg, Texas, 78539, United States

Location

Next Level Urgent Care

Houston, Texas, 77057, United States

Location

Laguna Clinical Research

Laredo, Texas, 78041, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, United States

Location

BFHC Research, LLC

San Antonio, Texas, 78249, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW

Shenandoah, Texas, 77384, United States

Location

Javara - Privia Medical Group North Texas - Stephenville

Stephenville, Texas, 76401, United States

Location

Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW

The Woodlands, Texas, 77384, United States

Location

Eastside Research Associates

Redmond, Washington, 98052, United States

Location

Related Publications (1)

• 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.

  PMID: 39486089 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 5, 2023
• Study Start: May 23, 2023
• Primary Completion: September 13, 2023
• Study Completion: October 11, 2023
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (53)