EUCTR2022-000075-39-HU进行中（未招募）1 期
A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE
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
- 142
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. Male or female participants:
- •Cohort 1: Weight =40 kg
- •a. =12 to <18 years
- •b. =6 to <12 years
- •Cohort 2: Weight =20 kg to <40 kg, =6 to <18 years
- •Cohort 3: =2 to <6 years
- •Cohort 4: =1 month to <2 years
- •Cohort 5: <1 month
- •- From birth (postmenstrual age of 44 weeks or greater at the time of screening) to <18 years of age
- •- Negative urine pregnancy test for female participants who are biologically capable of having children. Refer to Appendix 4 for reproductive criteria for
- •male (Section 10.4.1) and female (Section 10.4.2) participants.
- •- Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner.
- •Note: If the childbearing potential changes after start of the study (eg, a premenarchal female participant experiences menarche) or the risk of
- •pregnancy changes (eg, a female participant who was not heterosexually active becomes active), the participant must discuss this with the investigator, who should determine if a female participant must begin a highly effective method of contraception or a male participant must use a condom. If reproductive status is questionable, additional evaluation should be considered.
- •2. Ability to swallow tablets confirmed by participants’ parent(s)/legal guardian(s) for Cohorts 1 and 2 using this presentation of nirmatrelvir/ritonavir. An age-appropriate formulation will be developed for subsequent cohorts.
- •3. Confirmed SARS-CoV-2 infection as determined by RT-PCR or another method of diagnosis approved by a health authority in any specimen collected within 72 hours prior to enrollment and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of enrollment and at least 1 of the specified signs/symptoms attributable to COVID-19 present on the day of enrollment.
- •Note: RT-PCR is the preferred method; however, with evolving approaches to confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed. The test result must be available to confirm eligibility. Participants may be enrolled based on positive results of a rapid SARSCoV-2 antigen test performed at screening.
- •4. Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19 including:
- •Risk factors for severe COVID-19 disease <18 years of age:
- •- Overweight or Obese (BMI [kg/m2] =85th percentile for age and gender based on CDC growth charts, see Appendix 8)
- •- For children <2 years of age, sex specific weight-for-length;
- •- Current smoker (cigarette smoking within the past 30 days) and history of at least 100 lifetime cigarettes;
- •- Immunosuppressive disease (eg, bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening
- •medications:
- •- Has received corticosteroids equivalent to prednisone =20 mg daily for at least 14 consecutive days within 30 days prior to study entry
- •- Has received treatment with biologics (eg, infliximab, ustekinumab), immunomodulators (eg, methotrexate, 6MP, azathioprine) or cancer chemotherapy within 90 days prior to study entry
- •- HIV infection with CD4 cell count <200 mm3 and a viral load greater than 200 copies/mL;
- •- Chronic lung disease
- •- If asthma, requires daily prescribed therapy;
排除标准
- •1. Hospitalization:
- •- History of hospitalization for the medical treatment of COVID-19.
- •- Current need for hospitalization or anticipated need for hospitalization within 48 hours after enrollment in the clinical opinion of the site investigator.
- •Note: Children hospitalized for quarantine only or who are in the hospital to receive treatment for other conditions may be eligible.
- •2. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
- •3. 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.
- •4. History of hypersensitivity or other contraindication to any of the components of the study intervention, as determined by the investigator.
- •5. 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.
- •6. Current or expected use of any prohibited medication(s) or those unwilling/unable to use a permitted concomitant medication(s) and 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 nirmatrelvir/ritonavir.
- •7. Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days prior to first dose of nirmatrelvir/ritonavir and during study treatment.
- •8. Use of monoclonal antibody treatment or convalescent COVID-19 plasma at any time during the course of the study
- •9. Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 therapeutics, through the longterm follow-up visit.
- •10. 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) or known prior participation in this trial or other trial involving nirmatrelvir/ritonavir.
- •11. Known history of any of the following abnormalities in clinical laboratory tests (within past 6 months of the screening visit):
- •- Total bilirubin =2 X ULN (except for Gilbert’s syndrome);
- •- Absolute neutrophil count <1000/mm3.
- •12. Receiving dialysis or have known moderate to severe renal impairment (CKD Grade 3b to 5) ie, eGFR or eCrCl (estimated creatinine clearance of <45 mL/min/1.73 m2) within 6 months of the screening visit using the age-appropriate calculation:
- •- If participant <1 month of age, use the Bedside Schwartz Equation;
- •- If participant =1 month to <2 years of age, use the Bedside Schwartz Equation;
- •- If participant =2 years to <12 years of age, use the Modified Schwartz Equation;
- •- If participant is =12 years to <18 years of age and is either receiving dialysis or has known moderate to severe renal impairment (CKD Grade 3b to 5) (estimated creatinine clearance of <45 mL/min) within 6 months of the screening visit use the Cockcroft-Gault Formula.
- •Note: If the investigator suspects the participant may have any of the above laboratory values, confirmatory tests should be performed at screenin
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