NCT06679140招募中3 期
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED IBUZATRELVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULT AND ADOLESCENT PARTICIPANTS WITH COVID-19 WHO ARE AT HIGH RISK OF PROGRESSING TO SEVERE ILLNESS
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 2,330
- 试验地点
- 447
- 主要终点
- Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality
研究概览
简要总结
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind with matching placebo
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
- •Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:
- •12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
- •50 to 64 years of age with at least two risk factors;
- •65 to 74 years of age with at least one risk factor;
- •For participants 75 years of age or older, there are no requirements related to risk factors.
- •The list of risk factors includes:
- •BMI ≥35 kg/m2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1 or Type 2 diabetes mellitus; Mild to moderate renal impairment; Neurodevelopmental disorders; Sickle cell disease; Moderate immunosuppression.
- •Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization. Randomization must occur no later than the 5th day, where the onset of symptoms is the first day.
- •Participants must be unable or unwilling to take nirmatrelvir/ritonavir.
排除标准
- •Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness (eg, SpO2 <94% on room air, respiratory rate >30 breaths/minute, or lung infiltrates >50%) or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
- •Receiving dialysis or have known severe renal impairment [ie, eGFR consistently <30 mL/min/1.73 m2 for adults or CrCl <30 mL/min for adolescents], using the serum creatinine-based CKD-EPI formula or the Cockroft Gault, respectively.
- •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.
- •Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
- •Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
- •Severely immunocompromised.
- •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.
- •History of hypersensitivity or other contraindication to any of the components of the study interventions.
- •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.
- •Current use of any prohibited concomitant medication(s).
- •10.Has received any other antiviral for the treatment of COVID-19, including remdesivir, nirmatrelvir/ritonavir, molnupiravir, or COVID-19 mAbs within 30 days or 5 half-lives [whichever is longer] prior to screening, or received convalescent COVID-19 plasma within 12 months.
- •12.Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day
- •13.Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
- •14.Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.
- •15.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.
研究组 & 干预措施
ibuzatrelvir
Experimental
Ibuzatrelvir administered orally every 12 hours (twice daily) for a total of 5 days.
干预措施: ibuzatrelvir (Drug)
placebo
Placebo Comparator
placebo administered orally every 12 hours (twice daily) for 5 days.
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality
时间窗: Day 1 through Day 28
The difference in proportions of patients requiring COVID 19 related emergency department visits with administration of supplemental oxygen, COVID-19 antiviral or IV treatment (eg hydration, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause death through Day 28 between ibuzatrelvir and placebo, among patients who were treated ≤5 days after COVID-19 symptom onset and who were not receiving background SoC treatment for their COVID-19 infection at baseline.
次要结局
- Proportion of participants with COVID-19-related hospitalization or all cause death through Day 28.(Day 1 to Day 28)
- Time to sustained resolution of all COVID-19 targeted symptoms(Day 1 to Day 28)
- Proportion of participants with post acute COVID-19 medical events(Day 29 to Week 24)
- Proportion of participants with cardiovascular, renal and pulmonary events(Day 1 to Week 24)
- Proportion of participants with Long COVID symptoms(Day 29 to Week 24)
- Changes from baseline in SARS-CoV-2 RNA levels in nasopharyngeal/nasal swabs(Day 1 through Day 34)
- Time to SARS-CoV-2 RNA <LLOQ(Day 1 through Day 34)
- Proportion of participants with SARS-CoV-2 RNA <LLOQ at each visit(Day 1 through Day 34)
- Proportion of participants with rebound in SARS-CoV-2 RNA levels in nasopharyngeal swab(Day 10 and Day 14)
- Proportion of participants with virologic and symptomatic rebound through Day 28(Day 10 to Day 34)
- Number of days in hospital and ICU stay in participants with hospitalization (all-cause).(Day 1 to Week 24)
- Number of medical visits through Week 24.(Day 1 to Week 24)
- Proportion of participants with hospitalization (all-cause) or death (all-cause) through Week 24.(Day 1 to Week 24)
- Time (days) to sustained alleviation of all targeted symptoms through Day 28.(Day 1 to Day 28)
- Proportion of participants with severe symptoms attributed to COVID-19 through Day 28.(Day 1 to Day 28)
- Duration of each targeted COVID-19 symptom.(Day 1 to Day 28)
- Proportion of participants with symptomatic rebound through Day 28.(Day 1 to Day 28)
- Incidence of treatment emergent adverse events(Day 1 to Day 34)
- Incidence of SAEs and AEs leading to discontinuations.(Day 1 to Day 34)
研究者
研究点 (447)
Loading locations...
相似试验
Unknown
3 期
Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)HIV InfectionsNCT00004981Glaxo Wellcome230
已完成
3 期
Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045)Hepatitis C, ChronicNCT01405560Merck Sharp & Dohme LLC42
已完成
3 期
Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR MutationCystic FibrosisNCT01707290Vertex Pharmaceuticals Incorporated125
已完成
3 期
Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)Hepatitis C, ChronicNCT01405937Merck Sharp & Dohme LLC51
招募中
3 期
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.CandidemiaCandidiasis, InvasiveNCT05421858Basilea Pharmaceutica450