EUCTR2021-002894-24-HU进行中（未招募）1 期
A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED PF-07321332/RITONAVIR IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF AN INDIVIDUAL WITH SYMPTOMATIC COVID-19
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 2,660
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Participants =18 years of age (or the minimum country specific age of consent if >18) at the screening visit.
- •WOCBP may be enrolled.
- •All fertile participants must agree to use a highly effective method of contraception.
- •2.Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •3.Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts (ie, living in the same residence, see Appendix 13) of an individual who is symptomatic and recently tested positive for SARS-CoV-2 (ie, index case: patient with symptomatic COVID-19). To be included in the study, participants must be randomized within 24 hours of their negative SARS-CoV-2 rapid antigen test and within 96 hours of collection of the index case’s first positive SARS-CoV-2 test.
- •Note: The index case will have confirmation of SARS-CoV-2 infection by RT-PCR or other molecular or antigen tests that detect viral RNA or protein (see Section 8.1.5).
- •Note: Participants with a negative screening SARS-CoV-2 local rapid antigen test result and whose baseline RT-PCR result is returned as positive would be allowed to remain on treatment in the study.
- •Note: Asymptomatic is defined as having no signs/symptoms consistent with COVID-19 and symptomatic is defined as having at least 1 of the specified signs or symptoms consistent with COVID-19 (see Appendix 9).
- •4.Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2394
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 266
排除标准
- •1.History of SARS-CoV-2 infection as determined by a molecular test (antibody, antigen, or nucleic acid) from any specimen collected at any time before or during the screening visit.
- •2.Experiencing measured fever (documented temperature >38°C or 100.4°F) or other signs or symptoms consistent with COVID-19.
- •3.Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, or primary biliary cirrhosis, ChildPugh Class B or C, or acute liver failure.
- •4.CKD or have known moderate to severe renal impairment.
- •5.Known HIV infection with viral load >400 copies/mL within the last 6 months or taking prohibited medications for HIV treatment (from known medical history within past 6 months of the screening visit)
- •6.Suspected or confirmed concurrent active systemic infection that may interfere with the evaluation of response to the study intervention.
- •7.Active cancer, other than localized skin cancer, requiring treatment (including palliative treatment) that must be administered/continued during the trial period.
- •8.Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life-threatening within 30 days prior to study entry, as determined by the investigator.
- •9.Has hypersensitivity or other contraindication to any of the components of the study intervention, as determined by the investigator.
- •10.Other 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.
- •11.Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance and for which elevated plasma concentrations may be associated with serious and/or life-threatening events during treatment and for 4 days after the last dose of PF-07321332/ritonavir.
- •12.Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days prior to first dose of PF-07321332/ritonavir and during study treatment.
- •13.Has received approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products.
- •14.Has received or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments during the study period (includes partial or full vaccinations for multiple-dose vaccines).
- •15.Is unwilling to abstain from participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 therapeutics, through the End of Study visit.
- •16.Previous administration with an investigational drug 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).
- •17.Known or prior participation in this trial or another trial involving PF-07321332.
- •18.Participants with known history of any of the following abnormalities in clinical laboratory tests (within 6 months of the screening visit):
- •AST or ALT level =2.5 X ULN;
- •Total bilirubin level =2 X ULN (= 3X ULN for Gilbert’s syndrome);
- •eGFR <45 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula46
研究者
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