ISRCTN88057279进行中（未招募）2 期
PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.1. Dialysis patients receiving in-centre haemodialysis, or
- •1.2. Diagnosis of vasculitis (according to Chapel Hill Consensus Conference 2012 definitions) and have received immunosuppression (including prednisolone =5 mg daily and/or an immunosuppressive agent (cyclophosphamide (oral or IV), rituximab, azathioprine, MMF, methotrexate, tociluzumab, alemtuzumab, abatacept, leflunomide) in the last 3 years, or
- •1.3. Transplant patients that have a functional kidney transplant (updated 15/05/2020, previously: Transplant patients)
- •2. Aged at least 18 years
- •3. No previous confirmed COVID-19 diagnosis
- •4. No symptoms highly suggestive of COVID-19 infection at screening or since 1st March 2020
- •Additional Inclusion Criteria (added 05/09/2023) (updated 12/03/2024):
- •5. Be a member of an immunocompromised population, which includes but is not limited to those groups listed in the core protocol as well as the following:
- •5.1. Primary immunodeficiency
- •5.2. Any Oncology, Haematology-Oncology or Haematology patient who is currently receiving or has received chemotherapy or who is immunocompromised as a result of their disease or treatment
- •5.3. Have a diagnosis of an autoimmune/inflammatory disease currently receiving immunosuppression including those individuals currently on Prednisolone =20mg daily for at least 4 weeks. Those who have received Rituximab or Alemtuzumab within the last 12 months would also be eligible.
- •5.4. Solid organ and haematopoietic stem cell transplant recipients
排除标准
- •1. Inability to provide informed consent
- •2. Hypersensitivity reaction to hydroxychloroquine, chloroquine or 4-aminoquinolines
- •3. Contraindication to taking hydroxychloroquine as prophylaxis e.g known epilepsy
- •4. Already taking chloroquine, hydroxychloroquine or 4-aminoquinolines
- •5. History of any retinopathy including diabetic retinopathy requiring laser therapy
- •6. Taking medications which are contra-indicated alongside HCQ - digoxin, halofantrine, amiodarone, moxifloxacin, cyclosporin, mefloquine, praziquantel
- •7. Known history of prolonged QTc
- •8. eGFR <15 ml/min
- •9. Multi-organ transplant recipient (added 15/05/2020)
- •Additional Exclusion Criteria (added 05/09/2023) (updated 12/03/2024):
- •In addition to the core exclusion criteria in the master protocol, the presence of any of the following will preclude participant inclusion:
- •10. If in the opinion of the PI it is not in the best interests of the participant to take part in the study - for example due to limited life expectancy (=12 months) due to pre-existing co-morbidities
- •11. History of hypersensitivity reaction to sotrovimab, one of its excipients or any other monoclonal antibody targeting SARS CoV-2
- •12. History of receiving any monoclonal antibody targeting SARS CoV-2 within the last 6 months
- •13. Admission to hospital for acute, unplanned care at the time of randomisation or in the two weeks prior to screening
- •14. History of receiving chimeric antigen receptor T-cell (CAR-T) therapy less than 4 weeks prior to consenting to take part in the study
研究者
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