Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04870333 | PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V | PHASE2 | COMPLETED | 2,240 | — | — | Feb 19, 2021 | Apr 16, 2025 | Jun 20, 2025 | 45 | United Kingdom |
The primary outcome for PROTECT is confirmed symptomatic COVID-19 infection during treatment. The primary outcome event is defined as the presence of both * PCR confirmed SARS-CoV2 and * One or more symptoms in keeping with COVID-19, including: * Respiratory (Cough +/- sputum and shortness of breath) * Constitutional (Pyrexia/chills, myalgia/arthralgia, fatigue, rash, headache, confusion) * Gastrointestinal (nausea/vomiting, diarrhoea, abdominal pain, loss of appetite) The date (time) of the primary outcome event is defined as the date of the confirmed COVID-19 test.
| Arm | Type | Description |
|---|---|---|
| Niclosamide | ACTIVE_COMPARATOR | 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 niclosamide | PLACEBO_COMPARATOR | 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. |
| Ciclesonide | ACTIVE_COMPARATOR | 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 ciclesonide | PLACEBO_COMPARATOR | Matched placebo contains the same solvent and propellant as the active product but no drug substance. |
| Sotrovimab | EXPERIMENTAL | 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 sotrovimab | PLACEBO_COMPARATOR | This will be in the form of 0.9% sodium chloride 100mL 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. |
| Name | Type | Description |
|---|---|---|
| Niclosamide | DRUG | 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. |
| Placebo | DRUG | 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. |
| Ciclesonide | DRUG | 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. |
| Sotrovimab | DRUG | 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. |
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...