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
Overview
- Phase
- Phase 2
- Intervention
- PF-07817883
- Conditions
- SARS-CoV-2 Infection
- Sponsor
- Pfizer
- Enrollment
- 240
- Locations
- 51
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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.
Arms & Interventions
Arm 1: low dose
Intervention: PF-07817883
Arm 2: medium dose
Intervention: PF-07817883
Arm 3: high dose
Intervention: PF-07817883
Arm 4: Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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
Time Frame: Baseline (Day 1), 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.
Secondary Outcomes
- 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).)
- Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities(From baseline (Day 1) up to Day 10)