The clinical manifestations of COVID-19 range from asymptomatic infection to mild, upper respiratory tract infections to severe viral pneumonia with associated respiratory failure and death. Some patients will also go on to develop multi-organ failure, with kidney, cardiac and neurological complications of SARS-CoV-2. The frequency of severe disease in hospitalised patients can be as high as 30%.
Several patient groups appear to be vulnerable to COVID-19 and at exceptionally high risk of adverse outcomes, including those with kidney disease requiring dialysis, in receipt of a kidney transplant, or with auto-immune diseases that might affect kidney function and require immunosuppression (e.g. vasculitis and glomerular diseases). These patient groups are also known to mount a suboptimal response to vaccination against viruses.
There are no drugs proven to prevent COVID-19 or to reduce the severity of illness if given as prophylaxis. The urgent need for interventions that provide effective prophylaxis against SARS-CoV2 is emphasised by a recent report commissioned by the UK Government projected 119,000 in-hospital deaths from COVID19 between September 2020 and June 2021 (95%CI 24,500 - 251,000). This suggests a ‘second wave’ could be considerably worse than the first. Outside the United Kingdom, the pandemic is still accelerating. An effective prophylactic treatment could save thousands of lives.
PROTECT is a randomised, double-blind, placebo-controlled event-driven trial evaluating the use of nasal niclosamide as a prophylactic agent against COVID-19 infection. PROTECT aims to enrol patients at particularly high risk of COVID-19 and its complications, seeking to test whether intranasal niclosamide might prevent the disease from occurring. Participants will be randomised 1:1 to niclosamide or matching placebo. Additional treatment arms may be added if further promising treatments become available. Approximately 1500 participants will be enrolled from three vulnerable patient populations: dialysis patients, kidney transplant recipients and those with vasculitis or another auto-immune kidney disease/glomerulonephritis (GN).