COVID-19 (SARS-CoV-2 infection) in dialysis, vasculitis, and kidney transplant patients Infections and Infestations
Conditions
Interventions
Current Intervention (04/01/2022) (updated 12/03/2024):
Patients will be randomised on 1:1 to receive either a single Intravenous Sotrovimab or standard care (placebo). Randomisation will be carried
Sponsors
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to confirmed COVID-19 diagnosis via online questionnaires at 6 weekly intervals | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration and severity of illness (including mortality) collected through linkage to medical databases and through review of medical records. | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactKerry Brusby
Outcome results
None listed