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

A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO EVALUATE VIROLOGICAL RESPONSE AND SAFETY OF ORAL PF-07817883 IN NON-HOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Drug: Placebo; Drug: PF-07817883

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Cullman, Alabama, United States, 35055
      • Cullman Clinical Trials
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • ClinMed
    • Surprise, Arizona, United States, 85378
      • Epic Medical Research - Surprise
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
  • California
    • Bakersfield, California, United States, 93301
      • Franco Felizarta, MD
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, Inc.
    • Chula Vista, California, United States, 91911
      • Velocity Clinical Research, Chula Vista
    • Colton, California, United States, 92324
      • Benchmark Research
    • Fullerton, California, United States, 92835
      • Ascada Health PC dba Ascada Research
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trials
    • Santa Ana, California, United States, 92704
      • Marvel Clinical Research - Santa Ana
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Herco Medical and Research Center Inc
    • Cutler Bay, Florida, United States, 33157
      • Advance Clinical Research Group
    • Fort Lauderdale, Florida, United States, 33308
      • Proactive Clinical Research,LLC
    • Hialeah, Florida, United States, 33010
      • Qway Research LLC
    • Hialeah Gardens, Florida, United States, 33018
      • Unlimited Medical Research Group LLC
    • Miami, Florida, United States, 33122
      • Angels Clinical Research Institute
    • Miami, Florida, United States, 33186
      • Coral Research Clinic Corp
    • Miami, Florida, United States, 33135
      • South Florida Research Center
    • Miami, Florida, United States, 33144
      • Bio-Medical Research LLC
    • Miami, Florida, United States, 33143
      • USPA Advance Concept Medical Research Group
    • Miami Lakes, Florida, United States, 33014
      • Palm Springs Community Health Center
    • Pembroke Pines, Florida, United States, 33029
      • DBC Research USA
    • Saint Petersburg, Florida, United States, 33705
      • GCP Research, Global Clinical professionals
  • Georgia
    • Albany, Georgia, United States, 31707
      • Javara - Privia Medical Group Georgia - Albany
    • Columbus, Georgia, United States, 31909
      • Centricity Research Columbus Acute Care
    • Columbus, Georgia, United States, 31904
      • Centricity Research Columbus Georgia Multispecialty
    • Union City, Georgia, United States, 30291
      • Rophe Adult and Pediatric Medicine/SKYCRNG
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Snake River Research
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Chan Medical School
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical Group, PLLC
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Henderson Clinical Trials
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research, LLC
  • North Carolina
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
    • Wilmington, North Carolina, United States, 28401
      • Accellacare - Wilmington
  • Ohio
    • Cincinnati, Ohio, United States, 45215
      • Wellnow Urgent Care and Research
    • Columbus, Ohio, United States, 43215
      • Remington Davis Clinical Research
    • Dayton, Ohio, United States, 45424
      • WellNow Urgent Care & Research
  • South Carolina
    • Easley, South Carolina, United States, 29640
      • Kur Research @ Bon Secours Mercy Health, Inc - Urgent Care Easley
  • Texas
    • Conroe, Texas, United States, 77384
      • Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
    • Cypress, Texas, United States, 77433
      • Javara - Privia Medical Group Gulf Coast - Cypress
    • Dallas, Texas, United States, 75234
      • DFW Clinical Research
    • Edinburg, Texas, United States, 78539
      • Proactive Clinical Research, LLC
    • Houston, Texas, United States, 77057
      • Next Level Urgent Care
    • Laredo, Texas, United States, 78041
      • Laguna Clinical Research
    • Lewisville, Texas, United States, 75057
      • Epic Clinical Research
    • San Antonio, Texas, United States, 78249
      • BFHC Research, LLC
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
    • Shenandoah, Texas, United States, 77384
      • Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
    • Stephenville, Texas, United States, 76401
      • Javara - Privia Medical Group North Texas - Stephenville
    • The Woodlands, Texas, United States, 77384
      • Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
  • Washington
    • Redmond, Washington, United States, 98052
      • Eastside Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
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:

1. Current need for hospitalization or anticipated need for hospitalization within 24h after randomization in the clinical opinion of the site investigator.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 4: Placebo	Drug: Placebo; Placebo
Experimental: Arm 1: low dose	Drug: PF-07817883; Arm 1: low dose Arm 2: medium dose Arm 3: high dose
Experimental: Arm 2: medium dose	Drug: PF-07817883; Arm 1: low dose Arm 2: medium dose Arm 3: high dose
Experimental: Arm 3: high dose	Drug: PF-07817883; Arm 1: low dose Arm 2: medium dose Arm 3: high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in SARS-CoV-2 RNA level	Baseline to day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in SARS-CoV-2 RNA level	Baseline, Day 3, 10 and 14
Incidence of treatment related Adverse Events (AE)	Baseline through Day 33
Incidence of Serious Adverse Events (SAE)	Baseline through Day 33
Incidence of clinically significant abnormal laboratory values	Baseline through Day 33
Incidence of AEs leading to discontinuations.	Baseline through Day 33
Incidence of clinically significant abnormal vital signs,	Baseline through Day33
Incidence of clinically significant abnormal ECGs	Baseline through Day 33

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): October 11, 2023

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; SARS COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: C5091003; 2022-002871-12 (Registry Identifier: CTIS (EU)); 2023-506667-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No