Preventative treatment for patients at risk of COVID-19 infection (PROTECT)
- Conditions
- COVID-19 (SARS-CoV-2 infection) in dialysis, vasculitis, and kidney transplant patientsInfections and Infestations
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 5000
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to confirmed COVID-19 diagnosis via online questionnaires at 6 weekly intervals
- Secondary Outcome Measures
Name Time Method Duration and severity of illness (including mortality) collected through linkage to medical databases and through review of medical records.