2024-511580-28-00撤回3 期
RECLAIM: an Adaptive Platform Trial for the Evaluation of Treatments for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Universitair Medisch Centrum Utrecht1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2024年8月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Assessed at 12 weeks (end of trial product use period): Patient-Reported Outcomes Measurement Information System Profile29 (PROMIS-29) physical health summary score
研究概览
简要总结
To determine the impact of each IP vs. control on patient-reported physical health-related quality of life (HRQoL)
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
- 是
入选标准
- •Adults aged 18 years or older.
- •Residing in the study area (defined in each respective CSA) for the duration of trial participation.
- •Persistent PASC signs and symptoms, including fatigue and/or PEM, for a period of at least 12 weeks after the onset of a SARS-CoV-2 infection. The symptoms were not present prior to the infection, but may have partially subsided and resurged after the infection.
- •Self-reported confirmation of having had a SARS-CoV-2 infection by: a. Positive SARS-CoV-2 nucleic acid amplification test (NAAT), such as PCR; b. Positive SARS-CoV-2 rapid diagnostic test, including home-administered tests; c. COVID-19 diagnosis by a medical specialist (GP or in-hospital), based on the above or other clinical tests and assessments.
- •Willing and able to provide informed consent via e-consent
- •Willing and able to perform trial procedures
- •Allowing their GP/pharmacy and the RECLAIM trial team to exchange medical information that is relevant for the participant’s safety and trial assessments.
排除标准
- •Having been diagnosed with (exacerbation of) a chronic disease that can account for the onset of the PASC-like symptoms.
- •Being hospitalised or institutionalised at screening. Patients can be rescreened after discharge.
- •Presence of a serious medical condition that would prevent completion of follow-up.
- •Currently enrolled, or having been enrolled within the last 30 days, in any other study where that study’s interventions or procedures may affect RECLAIM outcomes or procedures. Individuals can be rescreened after at least 30 days have passed since participation in such a study has been completed.
- •Applicable to all potential participants within one trial domain: The participant cannot be randomised to at least one IP arm and its control arm within a trial domain due to (refer to relevant TSAs for details): a. Known hypersensitivity to an active IP ingredient or excipient; b. Receiving a treatment that is contraindicated to a trial IP; c. Already using a trial IP, or a drug in the same drug class as a trial IP, outside of the trial; d. Any other reason why a trial IP cannot be used, such as (risk of) pregnancy or breastfeeding. During screening, these criteria will be assessed by questioning the patient, verification of prescription drug and contraceptive use in medical and/or pharmacy records, and verification of other exclusion criteria if indicated in the TSA. The absence of pregnancy in women of childbearing potential will be confirmed by a negative urine or serum pregnancy test. Refer to section 8.2.
- •for more details about pregnancy exclusion at inclusion and pregnancy prevention during follow-up.
结局指标
主要结局
Assessed at 12 weeks (end of trial product use period): Patient-Reported Outcomes Measurement Information System Profile29 (PROMIS-29) physical health summary score
Assessed at 12 weeks (end of trial product use period): Patient-Reported Outcomes Measurement Information System Profile29 (PROMIS-29) physical health summary score
次要结局
- Assessed at 12 weeks: ● PROMIS-29 mental health summary score ● PROMIS-29 domain scores: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, sleep disturbance.
- Assessed at 12 weeks: ● Checklist Individual Strength (CIS-20R) ● DePaul Symptom Questionnaire (DSQ-2) PEM questions ● PROMIS cognitive function 8a ● DSQ-2 POTS questions
- Assessed at 12 weeks: ● Frequency of related and unrelated (S)AEs in each IP arm compared to its control arm including their severity and outcome.
- Assessed at 12 weeks: ● Level of adherence to each IP versus the matching placebo control (if available). ● Percent of participants with adequate adherence for the specific IP.
- Assessed at 24 weeks (12 weeks after cessation of IP use): The proportion of participants that maintain HRQoL treatment success at 12 weeks.
- Exploratory: Same as above but stratified by phenotype.
- Exploratory: Same as above but stratified by pre-enrolment PASC symptom(s) duration.
- Exploratory: Described in relevant TSAs.
研究者
Janneke van de Wijgert
Scientific
Universitair Medisch Centrum Utrecht
研究点 (1)
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