NCT04870333 - PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V | Biotech Hunter

Enrollment

2,240

Participants

Timeline

Start Date

February 19, 2021

Primary Completion Date

April 16, 2025

Study Completion Date

April 16, 2025

Conditions

Covid19

Interventions

DRUG

Niclosamide

140μL of a 1% niclosamide ethanolamine solution in each nostril twice daily, equivalent to 1.4mg of niclosamide ethanolamine salt per nostril twice daily, approximately 12 hours apart. Total daily dose 5.6mg niclosamide ethanolamine salt (4.7mg free niclosamide acid). Treatment duration will be 6-9 months or up to 28 days after COVID-19 diagnosis unless hospitalised. Participants hospitalised with a diagnosis of COVID-19 should stop the randomised treatment immediately.

DRUG

Placebo

140μL of a matching placebo solution in each nostril twice daily. Treatment duration will be 6-9 months or up to 28 days after COVID-19 diagnosis unless hospitalised. Participants hospitalised with a diagnosis of COVID-19 should stop the randomised treatment immediately.

DRUG

Ciclesonide

"Participants will be prescribed ciclesonide once daily, administered as follows:~Two puffs (320 μg) inhaled via mouth sequentially One puff (160 μg) inhaled via nose Treatment duration will be 6-9 months or up to 28 days after COVID-19 diagnosis unless hospitalised. Participants hospitalised with a diagnosis of COVID-19 should stop the randomised treatment immediately."

DRUG

Placebo

"Matched placebo: two puffs inhaled via mouth sequentially and one puff inhaled via nose.~Treatment duration will be 6-9 months or up to 28 days after COVID-19 diagnosis unless hospitalised. Participants hospitalised with a diagnosis of COVID-19 should stop the randomised treatment immediately."

DRUG

Sotrovimab

"There will be a single infusion of sotrovimab administered at the beginning of the study.~500mg of sotrovimab solution (8mL) will be diluted in 42mL of 0.9% sodium chloride and administered by intravenous infusion. 50mLs to be infused over 30 minutes with a 0.2 micrometre inline filter. Four vials will be required for a 2000 mg dose."

DRUG

Placebo

There will be a single infusion placebo, in the form of 100mL 0.9% sodium chloride, administered at the beginning of the study.

Trial Locations (45)

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

Unknown

NHS Lanarkshire - University Hospital Monklands, Airdrie

University Hospitals Birmingham NHS Foundation Trust, Birmingham

Betsi Cadwaladr University Health Board, Bodelwyddan

Brighton and Sussex University Hospitals NHS Trust, Brighton

North Bristol NHS Trust, Bristol

West Suffolk NHS Foundation Trust, Bury St Edmunds

Royal Papworth Hospital NHS Foundation Trust, Cambridge

East Kent Hospitals University NHS Foundation Trust, Canterbury

Cardiff & Vale University Health Board, Cardiff

Epsom and St Helier University Hospitals NHS Trust, Carshalton

Ayrshire & Arran NHS Trust, Crosshouse

Dartford and Gravesham NHS Trust, Dartford

University Hospitals of Derby and Burton NHS Trust, Derby

Dorset County Hospital NHS Foundation Trust, Dorchester

NHS Tayside, Dundee

The Royal Devon and Exeter NHS Foundation Trust, Exeter

James Paget University Hospital NHS Foundation Trust, Great Yarmouth

Hull University Teaching Hospitals NHS Trust, Hull

Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust, Kings Lynn

Leeds Teaching Hospitals NHS Trust, Leeds

University Hospitals of Leicester NHS Trust, Leicester

Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool

Barts Health NHS Trust, London

Guy's and St Thomas' NHS Foundation Trust, London

Imperial College Healthcare NHS Trust, London

King's College Hospital NHS Foundation Trust, London

Royal Free NHS Foundation Trust, London

St George's University Hospitals NHS Foundation Trust, London

Manchester University NHS Foundation Trust, Manchester

Wirral University Teaching Hospital NHS Foundation Trust, Metropolitan Borough of Wirral

South Tees Hospitals NHS Foundation Trust, Middlesbrough

Nottingham University Hospitals NHS Trust, Nottingham

Oxford University Hospitals NHS Foundation Trust, Oxford

North West Anglia NHS Foundation Trust, Peterborough

University Hospitals Plymouth NHS Trust, Plymouth

Portsmouth Hospitals NHS Trust, Portsmouth

Royal Berkshire NHS Foundation, Reading

Salford Royal NHS Foundation, Salford

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

The Shrewsbury and Telford Hospital NHS Trust, Shrewsbury

East and North Hertfordshire NHS Trust, Stevenage

South Tyneside and Sunderland NHS Foundation Trust, Sunderland

The Royal Wolverhampton NHS Trust, Wolverhampton

York Teaching Hospital NHS Foundation Trust, York