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Prophylactic treatment for patients at high risk of COVID-19

PROphylaxis for paTiEnts at Risk of COVID-19 infecTion

Phase2; Phase3 Interventional Cambridge University Hospitals NHS Foundation Trust · NCT04870333

This study is testing if two existing medications can help prevent COVID-19 in people who are at high risk, like those on dialysis or with kidney issues.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment5000 (estimated)
Ages18 Years and up
SexAll
SponsorCambridge University Hospitals NHS Foundation Trust Academic / other
Drugs / interventionsTocilizumab, infliximab, adalimumab, Belimumab, Rituximab, Alemtuzumab, SOTROVIMAB, CAR-T, chimeric antigen receptor, chemotherapy, Methotrexate, Cyclophosphamide
Locations45 sites (Cambridge, Cambridgeshire and 44 other locations)
Trial IDNCT04870333 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of repurposed medications, specifically niclosamide and ciclesonide, in preventing COVID-19 infection among vulnerable populations such as dialysis patients, kidney transplant recipients, and individuals with autoimmune kidney diseases. Participants will be randomly assigned to receive either the active treatment or a placebo in a structured manner to assess the outcomes. The study seeks to identify potential prophylactic agents that can reduce the incidence and severity of COVID-19 in these high-risk groups, particularly as vaccine responses may be inadequate.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are on dialysis, have received a kidney transplant, or have autoimmune kidney diseases like vasculitis or systemic lupus erythematosus.

Not a fit: Patients who are not part of the specified vulnerable populations or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective prophylactic options for immunocompromised patients at high risk for severe COVID-19.

How similar studies have performed: Other studies have explored similar repurposing of medications for COVID-19, but this specific approach targeting these vulnerable populations is novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Cambridge, Cambridgeshire and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Covid19dialysissolid organ transplantvasculitisglomerulonephritissystemic lupus erythematosushaematopoietic stem cell transplantoncology or haematology patient who is or has received chemotherapy or who is immunocompromised as a result of their disease or treatment
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.