ISRCTN15674970已完成未知
Therapies for Long COVID in non-hospitalised individuals: from symptoms, patient-reported outcomes and immunology to targeted therapies (the TLC study)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 3,040
研究概览
简要总结
2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35879616/ Symptoms and risk factors for long COVID (added 01/08/2022) 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35473737/ (added 01/08/2022)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Non-hospitalised individuals aged 18 years and older with a positive RT-PCR test for SARS-CoV-2 in CPRD Aurum (minimum 2000 participants)
- •Propensity score-matched individuals without a diagnosis of COVID-19 (suspected or confirmed) in CPRD Aurum and without a positive SARS CoV-2 RT-PCR result and without a record of hospital admission within 28 days of the index date (minimum 500 participants)
排除标准
- •Aged under 18 years or hospitalised for COVID-19:
- •1. Individuals without a positive SARS CoV-2 RT-PCR test result in CPRD Aurum
- •2. Individuals with a hospital admission within 28 days of a positive SARS CoV-2 RT-PCR result in CPRD Aurum
- •3. Individuals aged under 18 years
- •4. Individuals unable/unwilling to provide informed consent
- •5. Individuals unable/unwilling to undertake the protocol activities
- •6. Individuals deemed appropriate for exclusion by their GP (e.g., on a palliative care register)
- •Matched controls - Group 1 (minimum of 500 participants):
- •1. Individuals with a diagnosis of COVID-19 in CPRD Aurum or positive SARS CoV-2 RT-PCR result in SGSS or GP record
- •2. Individuals coded in their primary care record as having suspected COVID-19
- •3. Individuals aged under 18 years
- •4. Individuals unable or unwilling to provide informed consent
- •5. Individuals unable or unwilling to undertake the protocol activities
- •6. Individuals deemed appropriate for exclusion by their GP (e.g., on a palliative care register)
- •Matched controls - Group 2 (50 participants):
- •1. Participants unable/unwilling to provide informed consent
- •2. Participants unable/unwilling to undertake the protocol activities
- •3. Participants deemed appropriate for exclusion by their GP (e.g., on palliative care register)
- •Bio-sampling and wearables (BioWear) cohort (200 Long COVID participants, 50 participants from Control Group 1 and 50 participants from Control Group 2):
- •1. Participants who have not previously consented to be contacted for bio-sampling/use of wearables
- •2. Participants unable/unwilling to provide informed consent
- •3. Participants unable/unwilling to undertake the protocol activities
- •Co-production workshops:
- •1. Individuals unable/unwilling to provide informed consent
- •2. Individuals unable/unwilling to attend a co-production workshop
研究者
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