Clinical trial · Interventional
PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V
PROphylaxis for paTiEnts at Risk of COVID-19 infecTion
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
COVID-19 (SARS-CoV2 virus) was declared a global pandemic by the WHO on 11th March 2020. Currently there are no drugs proven to prevent COVID-19 or to reduce the severity of illness if given as prophylaxis. Although vaccines are now available, there remains a need for other prophylactic agents until vaccine use becomes widespread globally and effectiveness and durability is established, particularly in immunocompromised individuals, for whom vaccine responses may be suboptimal. Efforts are underway to repurpose established drugs with well understood drug interactions and safety profiles. PROTECT-V is a platform trial to test prophylactic interventions against SARS-CoV2 infection in vulnerable patient populations at particularly high risk of COVID-19 and its complications, seeking to identify treatments that either might prevent the disease from occurring or may reduce the number of cases where the disease becomes serious or life-threatening. In PROTECT-V, multiple agents can be evaluated on the same platform across vulnerable populations, with the option of adding additional treatments at later time points as these become available. The expectation is for as many sites as possible to recruit to all available trial treatments at any time, however, the platform structure and randomisation/data collection systems allow sites to open the trial treatment arms according to their capacity. The trial opened with intranasal niclosamide and matched placebo, aiming to recruit 1500 vulnerable renal patients in February 2021. A parallel study protocol, was conducted in India, sponsored by The George Institute. Recruitment of around 750 Indian patients was completed in with the rest of the study arm recruitment in November 2022. The Niclosamide arm of the study was completed in June 2023. The second agent, intranasal and inhaled ciclesonide and matched placebo, was meant to be added to the platform in mid-2022 in the same renal patient population however it was unable to be included due to other factor. Sotrovimab and matched placebo have been added to the platform in August 2022 which aim to recruit approximately 800-1000 patients from the main study population with additional patient groups with primary immunodeficiency, any Haematology or Oncology patient who is currently receiving or has received chemotherapy or who is immunocompromised as a result of their disease or treatment, those with a diagnosis of an autoimmune or inflammatory disease receiving immunosuppression and also haematopoietic stem cell transplant recipients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Covid19 | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ciclesonide | Drug | — | UNRESOLVED |
| Niclosamide | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Sotrovimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- ACTIVE_COMPARATOR
- label
- Niclosamide
- description
- INN: Niclosamide Ethanolamine Chemical name (IUPAC): 5-chloro-N-(2-chloro-4-nitrophenyl)-2-hydroxybenzamide.2 aminoethanol CAS registry number: 1420-04-8 Lab code: UNI911 The IMPs niclosamide Nasal Spray 1% and matching Nasal Spray Placebo will be provided in 20 mL amber glass vials with nasal spray pumps, containing 8.5 mL of the respective solution, delivering 140 μL per spray shot. It is an isotonic and euhydric aqueous solution with red colour.
- interventionNames
- Drug: Niclosamide
- type
- PLACEBO_COMPARATOR
- label
- Placebo niclosamide
- description
- Placebo to match niclosamide will be supplied, stored, labelled, dispensed and dosed as for the active formulation. The placebo product is formulated to have the same appearance as the active solution.
- interventionNames
- Drug: Placebo
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDHumphrey TJL, Qian W, Chen-Xu M, Dowling F, Gatley K, Adhikari R, Hensman T, Stockley L, Bassi A, Bathla N, Dasgupta I, Dosanjh DPS, Jellingso M, Sorensen P, Jensen ML, Callesen AW, Bradley JR, Jha V, Sommer MOA, Hiemstra TF, Smith RM; PROTECT-V consortium. Prophylaxis for renal patients at risk of COVID-19 infection: results from the intranasal niclosamide randomised, double blinded, placebo controlled arm of the PROTECT-V platform trial. BMC Infect Dis. 2025 Feb 11;25(1):204. doi: 10.1186/s12879-025-10584-4. PMID 39934669
- DERIVEDHumphrey TJL, Dosanjh D, Hiemstra TF, Richter A, Chen-Xu M, Qian W, Jha V, Gatley K, Adhikari R, Dowling F, Smith RM. PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V). Trials. 2023 Mar 13;24(1):185. doi: 10.1186/s13063-023-07128-z. PMID 36915199