EUCTR2022-002827-36-DE进行中（未招募）1 期
AN INTERVENTIONAL, EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE A REPEAT 5-DAY COURSE OF NIRMATRELVIR/RITONAVIR COMPARED TO PLACEBO/RITONAVIR IN PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH REBOUND OF COVID-19 SYMPTOMS AND RAPID ANTIGEN TEST POSITIVITY
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
- 411
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 aged 12 years or older and weighing =40 kg at screening.
- •2. Participants must have written documentation with patient-reported 100% compliance (ie, completed a 5 day course of nirmatrelvir/ritonavir). They must have symptom alleviation or resolution in COVID-19 signs/symptoms followed by a worsening (rebound) of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir based on the judgement of both the participant and investigator.
- •3. The onset of rebound in COVID-19 symptoms must occur within 2 weeks (14 days) after the completion of the initial 5-day course of nirmatrelvir/ritonavir.
- •4. Onset of rebound in signs/symptoms attributable to COVID-19 within 48 hours prior to randomization and =1 sign/symptom attributable to COVID-19 present on the day of randomization.
- •5. SARS-CoV-2 infection as determined by rapid antigen testing in any specimen collected within 24 hours prior to randomization and collected within 2 weeks (14 days) after the completion of the initial 5-day treatment course of nirmatrelvir/ritonavir.
- •6. Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19.
- •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 351
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Current need for hospitalization, hospitalized for the index COVID-19 infection, or
- •anticipated need for hospitalization within 24h after randomization in the clinical
- •opinion of the site investigator.
- •2. History of severe chronic liver disease (eg, jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). No laboratory testing is needed.
- •3. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator.
- •4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
- •5. Receiving dialysis or eGFR <30 mL/min/1.73m2 (for adults) or eCrCl <30 mL/min (for adolescents) at screening using creatinine point of care device.
- •6. Oxygen saturation of <92% on room air obtained at rest within 24 hours prior to randomization.
- •7. Immunocompromised.
- •8. 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.
- •9. Current use of any prohibited concomitant medication(s).
- •10. COVID-19 vaccination within 14 days prior to study entry or anticipated COVID-19 vaccination through Day 34.
- •11. Receiving other COVID-19 specific treatments within 30 days of randomization and through Day 34, excluding the initial course of nirmatrelvir/ritonavir as well as blinded study medication.
- •12. Prior participation in this trial.
- •13. 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).
- •14. Females who are pregnant up to 14 weeks gestation. Pregnancy =14 weeks is not exclusionary.
- •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.
研究者
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