Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT04870333
Eligibility Criteria:
Core protocol
Inclusion Criteria:
* Be aged 18 years or older
* Have given written informed consent
* Be a member of one of the following vulnerable patients populations
* Dialysis - including in centre haemodialysis, home haemodialysis and peritoneal dialysis
* Kidney transplant receiving at least one of the immunosuppressive medications listed below
* Vasculitis (according to Chapel Hill Consensus Conference 2012 definitions) or systemic lupus erythematosus (SLE) receiving at least one of the immunosuppressive medications listed below
* Glomerulonephritis (includes prior histological confirmation of any of the following conditions - minimal change nephropathy, focal segmental glomerulosclerosis (FSGS), IgA nephropathy, primary membranous nephropathy, membranoproliferative glomerulonephritis or lupus nephritis) receiving at least one of the immunosuppressive medications listed below Ciclosporin Tacrolimus Azathioprine Mycophenolate Mofetil or Mycophenolic Acid Belatacept Methotrexate Tocilizumab Abatacept Leflunomide Sirolimus Prednisolone (current dose) \> 20mg daily for 8 weeks Anti-TNF (infliximab, adalimumab, etanercept) Belimumab Cyclophosphamide (within the last 6 months) Rituximab (in the last 12 months) or Rituximab in the last 5 years and IgG level \<5g/l Alemtuzumab (in the last 12 months)
Exclusion Criteria:
* Inability to provide informed consent or to comply with trial procedures
* COVID-19 at time of enrolment - either positive SARS CoV-2 swab (PCR) or symptoms highly suggestive of COVID-19 infection
* Known chronic liver disease or hepatic dysfunction as evidenced by ALT or AST \> 3x upper limit of the normal range
* Allergy or hypersensitivity to any of the active IMPs, or to any of the excipients used
* Pregnant, trying to conceive, unwilling to use contraception or breastfeeding
* Current participation in another interventional prophylactic or vaccine trial\* against COVID-19.
* Patients remain eligible for enrolment if they have received SARS-COV-2 vaccination as part of routine care.
NICLOSAMIDE ARM Additional exclusion criteria
* Significant structural nasal disease in the opinion of the investigator
* Prior participation in the niclosamide arm of the trial (if being re-screened for participation in a second interventional arm).
CICLESONIDE ARM Additional Exclusion Criteria
In addition to the core exclusion criteria in the master protocol, the presence of any of the following will preclude participant inclusion:
1. Significant structural nasal disease in the opinion of the investigator
2. Prior participation in the ciclesonide arm of the trial (if being re-screened for participation in a second interventional arm).
3. Currently taking inhaled corticosteroids - beclometasone dipropionate (aerosol inhaler and dry powder inhaler), budesonide (dry powder inhaler and single-dose units for nebulization), ciclesonide (aerosol inhaler), fluticasone propionate (dry powder inhaler, aerosol inhaler, and single-dose units for nebulization), mometasone furoate (dry powder inhaler).
4. Received a live vaccine within last 14 days - ciclesonide increases risk of generalised infection: influenza, MMR, rotavirus, typhoid, varicella-zoster (shingles), yellow fever.
5. Taking one of the following medications ○ Systemic Ketoconazole, itraconazole, ritanovir, nelfinavir
SOTROVIMAB ARM Additional Inclusion Criteria
• 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:
* Primary immunodeficiency
* 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
* 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.
* Solid organ and haematopoietic stem cell transplant recipients
Additional Exclusion Criteria
In addition to the core exclusion criteria in the master protocol, the presence of any of the following will preclude participant inclusion:
* 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
* History of hypersensitivity reaction to sotrovimab, one of its excipients or any other monoclonal antibody targeting SARS CoV-2
* History of receiving any monoclonal antibody targeting SARS CoV-2 within the last 6 months
* Admission to hospital for acute, unplanned care at the time of randomisation or in the two weeks prior to screening
* History of receiving chimeric antigen receptor T-cell (CAR-T) therapy less than 4 weeks prior to consenting to take part in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04870333
Study Brief:
Protocol Section:
NCT04870333