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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

Primary Purpose

SARS-CoV-2 Infection

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-07817883
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring COVID-19, SARS COVID-19

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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. Expected to receive any dose of a SARS-CoV-2 vaccine within 14 days of randomization or during the study. 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. Known prior participation in this trial 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.

Sites / Locations

  • Cullman Clinical Trials
  • ClinMed
  • Epic Medical Research - Surprise
  • Applied Research Center of Arkansas
  • Franco Felizarta, Md
  • Hope Clinical Research, Inc.
  • Velocity Clinical Research, Chula Vista
  • Benchmark Research
  • Ascada Health PC dba Ascada Research
  • Long Beach Clinical Trials
  • Marvel Clinical Research - Santa Ana
  • Herco Medical and Research Center Inc
  • Advance Clinical Research Group
  • Proactive Clinical Research,LLC
  • Unlimited Medical Research Group
  • Qway Research LLC
  • Palm Springs Community Health Center
  • Angels Clinical Research Institute
  • South Florida Research Center
  • USPA Advance Concept Medical Research Group
  • Bio-Medical Research LLC
  • Coral Research Clinic Corp
  • DBC Research USA
  • GCP Research, Global Clinical professionals
  • Javara - Privia Medical Group Georgia - Albany
  • Centricity Research Columbus Georgia Multispecialty
  • Centricity Research Columbus Acute Care
  • Rophe Adult and Pediatric Medicine/SKYCRNG
  • Snake River Research
  • University of Massachusetts Chan Medical School
  • Great Lakes Research Group, Inc.
  • Mercury Street Medical Group, PLLC
  • Henderson Clinical Trials
  • Excel Clinical Research, LLC
  • Monroe Biomedical Research
  • Accellacare - Wilmington
  • Wellnow Urgent Care and Research
  • Remington Davis Clinical Research
  • WellNow Urgent Care & Research
  • Kur Research @ Bon Secours Mercy Health, Inc - Urgent Care Easley
  • Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
  • Javara - Privia Medical Group Gulf Coast - Cypress
  • DFW Clinical Research
  • Proactive Clinical Research, LLC
  • Next Level Urgent Care
  • Laguna Clinical Research
  • Epic Clinical Research
  • BFHC Research, LLC
  • Consano Clinical Research, LLC
  • Javara - Privia Medical Group North Texas - Stephenville
  • Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
  • Eastside Research Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1: low dose

Arm 2: medium dose

Arm 3: high dose

Arm 4: Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in SARS-CoV-2 RNA level

Secondary Outcome Measures

Change from baseline in SARS-CoV-2 RNA level
Incidence of treatment related Adverse Events (AE)
Incidence of Serious Adverse Events (SAE)
Incidence of clinically significant abnormal laboratory values
Incidence of AEs leading to discontinuations.
Incidence of clinically significant abnormal vital signs,
Incidence of clinically significant abnormal ECGs

Full Information

First Posted
April 4, 2023
Last Updated
October 5, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05799495
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
September 13, 2023 (Actual)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
Keywords
COVID-19, SARS COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: low dose
Arm Type
Experimental
Arm Title
Arm 2: medium dose
Arm Type
Experimental
Arm Title
Arm 3: high dose
Arm Type
Experimental
Arm Title
Arm 4: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-07817883
Intervention Description
Arm 1: low dose Arm 2: medium dose Arm 3: high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in SARS-CoV-2 RNA level
Time Frame
Baseline to day 5
Secondary Outcome Measure Information:
Title
Change from baseline in SARS-CoV-2 RNA level
Time Frame
Baseline, Day 3, 10 and 14
Title
Incidence of treatment related Adverse Events (AE)
Time Frame
Baseline through Day 33
Title
Incidence of Serious Adverse Events (SAE)
Time Frame
Baseline through Day 33
Title
Incidence of clinically significant abnormal laboratory values
Time Frame
Baseline through Day 33
Title
Incidence of AEs leading to discontinuations.
Time Frame
Baseline through Day 33
Title
Incidence of clinically significant abnormal vital signs,
Time Frame
Baseline through Day33
Title
Incidence of clinically significant abnormal ECGs
Time Frame
Baseline through Day 33

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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. Expected to receive any dose of a SARS-CoV-2 vaccine within 14 days of randomization or during the study. 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. Known prior participation in this trial 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Cullman Clinical Trials
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Facility Name
ClinMed
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Epic Medical Research - Surprise
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85378
Country
United States
Facility Name
Applied Research Center of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Franco Felizarta, Md
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Hope Clinical Research, Inc.
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Velocity Clinical Research, Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Benchmark Research
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Ascada Health PC dba Ascada Research
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Long Beach Clinical Trials
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Marvel Clinical Research - Santa Ana
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Herco Medical and Research Center Inc
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Advance Clinical Research Group
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Proactive Clinical Research,LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Unlimited Medical Research Group
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33018
Country
United States
Facility Name
Qway Research LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Facility Name
Palm Springs Community Health Center
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Angels Clinical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
South Florida Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
USPA Advance Concept Medical Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Bio-Medical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Coral Research Clinic Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
DBC Research USA
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
GCP Research, Global Clinical professionals
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Javara - Privia Medical Group Georgia - Albany
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Centricity Research Columbus Georgia Multispecialty
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Centricity Research Columbus Acute Care
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
Rophe Adult and Pediatric Medicine/SKYCRNG
City
Union City
State/Province
Georgia
ZIP/Postal Code
30291
Country
United States
Facility Name
Snake River Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
University of Massachusetts Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Mercury Street Medical Group, PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Henderson Clinical Trials
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Excel Clinical Research, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Monroe Biomedical Research
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Accellacare - Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Wellnow Urgent Care and Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Remington Davis Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
WellNow Urgent Care & Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Kur Research @ Bon Secours Mercy Health, Inc - Urgent Care Easley
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
City
Conroe
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Javara - Privia Medical Group Gulf Coast - Cypress
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Facility Name
DFW Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Proactive Clinical Research, LLC
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Next Level Urgent Care
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
Laguna Clinical Research
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Epic Clinical Research
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Facility Name
BFHC Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Consano Clinical Research, LLC
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Javara - Privia Medical Group North Texas - Stephenville
City
Stephenville
State/Province
Texas
ZIP/Postal Code
76401
Country
United States
Facility Name
Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Eastside Research Associates
City
Redmond
State/Province
Washington
ZIP/Postal Code
98052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C5091003
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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