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

SARS-CoV-2 Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05799495
• Other study ID #: C5091003
• Secondary ID: 2022-002871-1220
• Status: Completed
• Phase: Phase 2
• Start date: May 24, 2023
• Est. completion date: October 11, 2023

Study information

• Verified date: December 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: October 11, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Drug:
• PF-07817883
Arm 1: low dose Arm 2: medium dose Arm 3: high dose
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Javara - Privia Medical Group Georgia - Albany	Albany	Georgia
United States	Franco Felizarta, Md	Bakersfield	California
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Mercury Street Medical Group, PLLC	Butte	Montana
United States	Hope Clinical Research, Inc.	Canoga Park	California
United States	Velocity Clinical Research, Chula Vista	Chula Vista	California
United States	Wellnow Urgent Care and Research	Cincinnati	Ohio
United States	Benchmark Research	Colton	California
United States	Centricity Research Columbus Acute Care	Columbus	Georgia
United States	Centricity Research Columbus Georgia Multispecialty	Columbus	Georgia
United States	Remington Davis Clinical Research	Columbus	Ohio
United States	Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW	Conroe	Texas
United States	Herco Medical and Research Center Inc	Coral Gables	Florida
United States	Cullman Clinical Trials	Cullman	Alabama
United States	Advance Clinical Research Group	Cutler Bay	Florida
United States	Javara - Privia Medical Group Gulf Coast - Cypress	Cypress	Texas
United States	DFW Clinical Research	Dallas	Texas
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	Proactive Clinical Research, LLC	Edinburg	Texas
United States	Proactive Clinical Research,LLC	Fort Lauderdale	Florida
United States	Ascada Health PC dba Ascada Research	Fullerton	California
United States	Henderson Clinical Trials	Henderson	Nevada
United States	Qway Research LLC	Hialeah	Florida
United States	Unlimited Medical Research Group LLC	Hialeah Gardens	Florida
United States	Next Level Urgent Care	Houston	Texas
United States	Snake River Research	Idaho Falls	Idaho
United States	Laguna Clinical Research	Laredo	Texas
United States	Excel Clinical Research, LLC	Las Vegas	Nevada
United States	Epic Clinical Research	Lewisville	Texas
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Long Beach Clinical Trials	Long Beach	California
United States	Angels Clinical Research Institute	Miami	Florida
United States	Bio-Medical Research LLC	Miami	Florida
United States	Coral Research Clinic Corp	Miami	Florida
United States	South Florida Research Center	Miami	Florida
United States	USPA Advance Concept Medical Research Group	Miami	Florida
United States	Palm Springs Community Health Center	Miami Lakes	Florida
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	DBC Research USA	Pembroke Pines	Florida
United States	ClinMed	Phoenix	Arizona
United States	Eastside Research Associates	Redmond	Washington
United States	GCP Research, Global Clinical professionals	Saint Petersburg	Florida
United States	BFHC Research, LLC	San Antonio	Texas
United States	Marvel Clinical Research - Santa Ana	Santa Ana	California
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	Epic Medical Research - Surprise	Surprise	Arizona
United States	Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW	The Woodlands	Texas
United States	Rophe Adult and Pediatric Medicine/SKYCRNG	Union City	Georgia
United States	Accellacare - Wilmington	Wilmington	North Carolina
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in SARS-CoV-2 RNA level		Baseline to day 5
Secondary	Change from baseline in SARS-CoV-2 RNA level		Baseline, Day 3, 10 and 14
Secondary	Incidence of treatment related Adverse Events (AE)		Baseline through Day 33
Secondary	Incidence of Serious Adverse Events (SAE)		Baseline through Day 33
Secondary	Incidence of clinically significant abnormal laboratory values		Baseline through Day 33
Secondary	Incidence of AEs leading to discontinuations.		Baseline through Day 33
Secondary	Incidence of clinically significant abnormal vital signs,		Baseline through Day33
Secondary	Incidence of clinically significant abnormal ECGs		Baseline through Day 33

External Links

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