2024-517671-21-00招募中3 期
C5091018 - An Interventional Efficacy And Safety, Phase 3, Randomized, Double-Blind, 3-Arm Study To Investigate Ibuzatrelvir in Adults With Symptomatic COVID-19 Who Are Severely Immunocompromised
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 94
- 试验地点
- 38
- 主要终点
- Proportion of participants with the composite endpoint of: • COVID-19-related emergency department (ED) visits with administration of supplemental oxygen, COVID-19 antiviral, or intravenous (IV) treatment (eg, hydration, antibiotics, or corticosteroids); COVID-19-related hospitalization; or all-cause mortality by Day 38, or • Evidence of recurrent or persistent SARS-CoV-2 infection, [CCI]
研究概览
简要总结
To compare the efficacy of ibuzatrelvir alone or combined with remdesivir on clinical and virological responses in symptomatic adult participants with COVID-19 who are severely immunocompromised.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- •Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test as noted in Section 8.2.4) in nasal specimen collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization (see Section 10.10 for criteria). Randomization must occur no later than the fifth day, where the onset of symptoms is the first day.
- •Severely immunocompromised due to: Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy; Active hematologic malignancy (eg, chronic lymphocytic lymphoma, non- Hodgkin lymphoma, multiple myeloma, acute leukemia); Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy; Currently receiving B-cell depleting therapies (eg, rituximab).
排除标准
- •Current need for supplemental oxygen for treatment of COVID-
- •Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by 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.
- •Prior participation in this trial or any clinical trial of ibuzatrelvir.
- •Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.
- •Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- •Receiving dialysis or have known severe renal impairment (ie, eGFR <30 mL/min/1.73 m2) within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula.
- •Active liver disease with AST or ALT >3 ULN, total bilirubin ≥2 × ULN (for Gilbert’s syndrome, direct bilirubin >ULN is exclusionary) within the past 3 months, or liver function impairment with Class C per Child Pugh classification.
- •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.
- •Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
- •Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- •Has received any other antiviral for the treatment of the current COVID-19 infection, including remdesivir, nirmatrelvir/ritonavir, molnupiravir, or mAb treatment (within 30 days or 5 half-lives [whichever is longer] prior to screening), or received convalescent COVID-19 plasma within 12 months. Use of mAb therapy for prevention (eg, pemivibart) of COVID-19 is prohibited within 3 months prior to screening.
- •Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). Refer to Section 6.9.
结局指标
主要结局
Proportion of participants with the composite endpoint of: • COVID-19-related emergency department (ED) visits with administration of supplemental oxygen, COVID-19 antiviral, or intravenous (IV) treatment (eg, hydration, antibiotics, or corticosteroids); COVID-19-related hospitalization; or all-cause mortality by Day 38, or • Evidence of recurrent or persistent SARS-CoV-2 infection, [CCI]
Proportion of participants with the composite endpoint of: • COVID-19-related emergency department (ED) visits with administration of supplemental oxygen, COVID-19 antiviral, or intravenous (IV) treatment (eg, hydration, antibiotics, or corticosteroids); COVID-19-related hospitalization; or all-cause mortality by Day 38, or • Evidence of recurrent or persistent SARS-CoV-2 infection, [CCI]
次要结局
- Time to sustained alleviation of all targeted COVID-19 symptoms through Day 38.
- Proportion of participants with no [CCI]
- Proportion of participants with evidence of recurrent or persistent SARS-CoV-2 infection, [CCI]
- Proportion of participants with COVID-19-related ED visits with administration of supplemental oxygen, COVID-19 antiviral, or IV treatment (eg, hydration, antibiotics, or corticosteroids), COVID-19-related hospitalization, or all-cause mortality through Day 38.
- Change from baseline in SARS-CoV-2 RNA level in NP or nasal swabs over time.
- Proportion of participants with SARS-CoV-2 NP or nasal RNA< LLOQ at each time point through Day 38.
- Proportion of participants with viral rebound in SARS-CoV-2 RNA level in NP or nasal swabs through Day 38 visit (in both virologic responders and regardless of virologic response).
- Time to sustained NP or nasal swab SARS-CoV-2 RNA< LLOQ through Day 38.
- Incidence of treatment-emergent adverse events (TEAEs).
- Incidence of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuations.
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (38)
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