PROphylaxis for paTiEnts at Risk of COVID-19 infecTion

Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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, will be conducted in India, sponsored by The George Institute. Recruitment of approximately 750 Indian patients will commence in February 2022. The second agent, intranasal and inhaled ciclesonide and matched placebo, will be added to the platform in early 2022 in the same renal patient population. Sotrovimab and matched placebo will be added to the platform in early 2022 in patients who have mounted sub-optimal vaccine responses to vaccines against SARS CoV-2.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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)

Locations
Other Locations
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Recruiting
Birmingham
Betsi Cadwaladr University Health Board
Recruiting
Bodelwyddan
Brighton and Sussex University Hospitals NHS Trust
Recruiting
Brighton
North Bristol NHS Trust
Recruiting
Bristol
Cambridge University Hospitals NHS Foundation Trust
Recruiting
Cambridge
East Kent Hospitals University NHS Foundation Trust
Recruiting
Canterbury
Cardiff & Vale University Health Board
Recruiting
Cardiff
Epsom and St Helier University Hospitals NHS Trust
Recruiting
Carshalton
Ayrshire & Arran NHS Trust
Recruiting
Crosshouse
Dartford and Gravesham NHS Trust
Recruiting
Dartford
University Hospitals of Derby and Burton NHS Trust
Recruiting
Derby
Dorset County Hospital NHS Foundation Trust
Recruiting
Dorchester
NHS Tayside
Recruiting
Dundee
The Royal Devon and Exeter NHS Foundation Trust
Recruiting
Exeter
James Paget University Hospital NHS Foundation Trust
Recruiting
Great Yarmouth
Hull University Teaching Hospitals NHS Trust
Recruiting
Hull
Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust
Recruiting
King's Lynn
University Hospitals of Leicester NHS Trust
Recruiting
Leicester
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Recruiting
Liverpool
Barts Health NHS Trust
Recruiting
London
Guy's and St Thomas' NHS Foundation Trust
Recruiting
London
Imperial College Healthcare NHS Trust
Recruiting
London
King's College Hospital NHS Foundation Trust
Recruiting
London
Royal Free NHS Foundation Trust
Recruiting
London
St George's University Hospitals NHS Foundation Trust
Recruiting
London
Nottingham University Hospitals NHS Trust
Recruiting
Nottingham
Oxford University Hospitals NHS Foundation Trust
Recruiting
Oxford
Royal Berkshire NHS Foundation
Recruiting
Reading
Salford Royal NHS Foundation
Recruiting
Salford
Sheffield Teaching Hospitals NHS Foundation Trust
Recruiting
Sheffield
East and North Hertfordshire NHS Trust
Recruiting
Stevenage
South Tyneside and Sunderland NHS Foundation Trust
Recruiting
Sunderland
Wirral University Teaching Hospital NHS Foundation Trust
Recruiting
Wirral
The Royal Wolverhampton NHS Trust
Recruiting
Wolverhampton
York Teaching Hospital NHS Foundation Trust
Recruiting
York
Contact Information
Primary
Rona Smith, Dr
ronasmith@doctors.org.uk
+44 1223336817
Time Frame
Start Date: February 19, 2021
Estimated Completion Date: October 2024
Participants
Target number of participants: 5000
Treatments
Active Comparator: Niclosamide
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.
Placebo Comparator: Placebo niclosamide
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.
Active Comparator: Ciclesonide
Chemical name (IUPAC): 2-[(1S,2S,4R,8S,9S,11S,12S,13R)-6-cyclohexyl-11-hydroxy-9,13-dimethyl-16-oxo-5,7-dioxapentacycloicosa-14, 17-dien-8-yl]- 2-oxoethyl 2-methylpropanoate CAS registry number: 141845-82-1~It is a pressurised solution, intended for inhalation use and commercialised under the brand Alvesco. The recommended dose of ciclesonide is 160μg once daily, which leads to asthma control in the majority of patients. However, this may be increased if necessary to 320μg twice daily, in severe asthma.
Placebo Comparator: Placebo ciclesonide
Matched placebo contains the same solvent and propellant as the active product but no drug substance.
Experimental: Sotrovimab
Sotrovimab, VIR-7831, GSK4182136 Sterile solution for intravenous infusion, 62.5 mg/mL, intravenous infusion Colourless or yellow to brown, liquid solution 20 mM histidine, 7% sucrose (w/v), 0.04% PS80 (w/v), 5 mM L-methionine at pH 6.0
Placebo Comparator: Placebo sotrovimab
This will be in the form of 0.9% sodium chloride 50mL for infusion and will be sourced from commercially available stock by the site. It may be procured and stored as per sites usual procedures and only requires handling as an IMP upon dispensing and labelling.
Authors
Davinder Dosanjh, Nicholas Pritchard, Rona Smith, Ben Sutton
Sponsors
Leads: Cambridge University Hospitals NHS Foundation Trust
Collaborators: Addenbrookes Charitable Trust, UNION therapeutics, LifeArc, National Institute for Health Research, United Kingdom, GlaxoSmithKline, Kidney Research UK (KRUK)

This content was sourced from clinicaltrials.gov

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