COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04870333

Rona Smith, Dr

ronasmith@doctors.org.uk

2021-05-03

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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)

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: significant structural nasal disease in the opinion of the investigator prior participation in the ciclesonide arm of the trial (if being re-screened for participation in a second interventional arm). 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). received a live vaccine within last 14 days - ciclesonide increases risk of generalised infection: influenza, mmr, rotavirus, typhoid, varicella-zoster (shingles), yellow fever. 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

2

Cambridge University Hospitals NHS Foundation Trust

18

100

United Kingdom

Healthy volunteers

N/A

5000

Confirmed symptomatic COVID-19 infection during treatment

None

Phase 2/Phase 3

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