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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 240
- 试验地点
- 51
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm 1: low dose
干预措施: PF-07817883 (Drug)
Arm 2: medium dose
干预措施: PF-07817883 (Drug)
Arm 3: high dose
干预措施: PF-07817883 (Drug)
Arm 4: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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)