NL-OMON54244招募中2 期
euroinflammation and post-infectious fatigue in individuals with and without Covid-19 - COVFATI
niversitair Medisch Centrum0 个研究点目标入组 85 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Group 1. In order to participate in this study, individuals with a previous
- •COVID-19 infection and with post-infectious fatigue or cognitive complaints
- •should meet the following criteria:
- •1) The patient was diagnosed with symptomatic COVID-19, confirmed by a positive
- •PCR for SARS-CoV-2, positive SARS-CoV-2 serology or CO-RADS (COVID-19 Reporting
- •and Data System) 4 or 5 on CT-scan, or antigen quicktest, or had typical
- •symptoms and was part of a household in which another person was tested
- •positive by PCR 2 weeks before or after the first day of illness;
- •2) The patient is 3 months after being diagnosed with COVID-19 or after
- •hospital discharge in case the patient was admitted.
- •3) The patient experiences severe levels of fatigue (>= 40) on the fatigue
- •subscale of the Checklist Individual Strength [CIS-fatigue]) and/or cognitive
- •complaints (>= 15) on the concentration subscale of the Checklist Individual
- •Strength [CIS-concentration]. The severe fatigue or cognitive complaints
- •started with or increased substantially directly after the onset of symptoms of
- •4) The patient reports physical/social disability (<= 65 on the Rand36 physical
- •functioning subscale or a score of >= 10 on the Work and Social Adjustment
- •Scale [WSAS]10;
- •5) The patient is in the range 30-65 years of age (to ensure radiation safety)
- •6) The patient has sufficient command of the Dutch language
- •7) Genotyping of rs6971 must show that patient is a mixed or high affinity
- •Group 2. In order to participate in this study, individuals with a previous
- •COVID-19 infection and without post-infectious fatigue or cognitive complaints
- •should meet the following criteria:
- •1) The patient was diagnosed with symptomatic COVID-19, confirmed by a positive
- •PCR for SARS-CoV-2, positive SARS-CoV-2 serology or CO-RADS 4 or 5 on CT-scan,
- •or antigen quicktest, or had typical symptoms and was part of a household in
- •which another person was tested positive by PCR 2 weeks before or after the
- •first day of illness;
- •2) The patient is 3 months after being diagnosed with COVID-19 or after
- •hospital discharge in case the patient was admitted.
- •3) The patient experiences no significant levels of fatigue (< 35 on the
- •fatigue subscale of the Checklist Individual Strength [CIS-fatigue]) or
- •cognitive complaints (<15 on the concentration subscale of the Checklist
- •Individual Strength [CIS-concentration]) and does not subjectively major
- •symptoms of fatigue. or cognitive complaints. Based upon average of normal
- •population +1SD
- •4) The patient reports no physical/social disability (> 65 on the Rand36
- •physical functioning subscale or a score of < 10 on the Work and Social
- •Adjustment Scale [WSAS]10;
- •5) The patient is in the range 30-65 years of age (to ensure radiation safety)
- •6) The patient has sufficient command of the Dutch language
- •7) Genotyping of rs6971 must show that patient is a mixed or high affinity
- •Group 3. Healthy controls should meet the following criteria:
- •1) Should be negatively tested for COVID-19 trough PCR, serology, antibodies,
- •or via antigen quicktest
- •2) No evidence for substantial fatigue or cognitive complaints as evidenced by
- •the CIS subscale fatigue (<35) and CIS subscale concentration (<15) and does
- •not subjectively major symptoms of fatigue or cognitive complaints. Based upon
排除标准
- •1) Rs6971 shows low affinity binding
- •2) Patients who are unable to lay still for scanning due to claustrophobia or
- •severe back pain or trypanophobia (fear of needles)
- •3) Gross neurological pathology (strategic or lobar infarcts) on MRI or CT that
- •may interfere with the interpretation of the PET scan.
- •4) Post-infectious complaints before COVID-19 or any other current disease of
- •infection that is known to cause substantial fatigue
研究者
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