Clinical trial NCT05799495: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: SARS-CoV-2 Infection
Keywords: COVID-19
SARS COVID-19
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-04-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline (Day 1), Day 5
Secondary outcomes:
measure: Change From Baseline in Log10 Transformed SARS-CoV-2 RNA Level on Days 3, 10 and 14
timeFrame: Baseline (Day 1), Day 3, Day 10 and Day 14
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From start of study intervention up to 28 days after last dose of study intervention (up to 33 days)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuations
timeFrame: From start of study intervention up to 28 days after last dose of study intervention (up to 33 days)
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
measure: Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities
timeFrame: From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
measure: Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities
timeFrame: From baseline (Day 1) up to Day 10
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Phoenix
country: United States
facility: ClinMed
state: Arizona
city: Surprise
country: United States
facility: Epic Medical Research - Surprise
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Bakersfield
country: United States
facility: Franco Felizarta, Md
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Chula Vista
country: United States
facility: Velocity Clinical Research, Chula Vista
state: California
city: Colton
country: United States
facility: Benchmark Research
state: California
city: Fullerton
country: United States
facility: Ascada Health PC dba Ascada Research
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials
state: California
city: Santa Ana
country: United States
facility: Marvel Clinical Research - Santa Ana
state: California
city: Coral Gables
country: United States
facility: Herco Medical and Research Center Inc
state: Florida
city: Cutler Bay
country: United States
facility: Advance Clinical Research Group
state: Florida
city: Fort Lauderdale
country: United States
facility: Proactive Clinical Research,LLC
state: Florida
city: Hialeah Gardens
country: United States
facility: Unlimited Medical Research Group LLC
state: Florida
city: Hialeah
country: United States
facility: Qway Research LLC
state: Florida
city: Miami Lakes
country: United States
facility: Palm Springs Community Health Center
state: Florida
city: Miami
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: South Florida Research Center
state: Florida
city: Miami
country: United States
facility: USPA Advance Concept Medical Research Group
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research LLC
state: Florida
city: Miami
country: United States
facility: Coral Research Clinic Corp
state: Florida
city: Pembroke Pines
country: United States
facility: DBC Research USA
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research, Global Clinical professionals
state: Florida
city: Albany
country: United States
facility: Javara - Privia Medical Group Georgia - Albany
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Columbus Georgia Multispecialty
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Columbus Acute Care
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Idaho Falls
country: United States
facility: Snake River Research
state: Idaho
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Henderson
country: United States
facility: Henderson Clinical Trials
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC
state: Nevada
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: Cincinnati
country: United States
facility: Wellnow Urgent Care and Research
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis, Inc
state: Ohio
city: Dayton
country: United States
facility: WellNow Urgent Care & Research
state: Ohio
city: Easley
country: United States
facility: Kur Research @ Bon Secours Mercy Health, Inc - Urgent Care Easley
state: South Carolina
city: Conroe
country: United States
facility: Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
state: Texas
city: Cypress
country: United States
facility: Javara - Privia Medical Group Gulf Coast - Cypress
state: Texas
city: Dallas
country: United States
facility: DFW Clinical Research
state: Texas
city: Edinburg
country: United States
facility: Proactive Clinical Research LLC
state: Texas
city: Houston
country: United States
facility: Next Level Urgent Care
state: Texas
city: Laredo
country: United States
facility: Laguna Clinical Research
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research
state: Texas
city: San Antonio
country: United States
facility: BFHC Research, LLC
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Shenandoah
country: United States
facility: Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
state: Texas
city: Stephenville
country: United States
facility: Javara - Privia Medical Group North Texas - Stephenville
state: Texas
city: The Woodlands
country: United States
facility: Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
state: Texas
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: