PROphylaxis for paTiEnts at risk of COVID-19 infecTion
Sponsor: CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST
CI: Dr Thomas Hiemstra
Approval Date: 17 March 2021
COVID-19 (novel coronavirus-induced disease) 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. There is also no vaccine for SARS-CoV-2. Efforts are underway to repurpose established drugs with well understood drug interactions and safety profiles. A number of clinical trials have been established at great speed following the onset of the pandemic (e.g.PRINCIPLE,RECOVERY) but none of these are enrolling participants with significantly reduced kidney function and/or receiving certain kinds of immunosuppressive medicines such as solid organ transplant recipients. The PROTECT clinical trial aims to enrol patients at particularly high risk of COVID-19 and its complications, seeking to test the use of nasal nicolosamide treatment as a prophylactic measure that either might prevent the disease from occurring or may reduce the number of cases where the disease becomes serious or life-threatening. PROTECT is a randomised, double blind, placebo controlled event driven trial. Patients will be eligible for recruitment to the trial if they fall within one of the following vulnerable populations: a)patients receiving dialysis, b)kidney transplant patients, c)patients with vasculitis or glomerulonephritis. A total of 1500 participants will be randomised to active treatment or placebo, stratified by PROTECT sub-population, age and participating sites. Enrolment to the trial will be via an online platform following informed consent with a face to face screening visit. Subsequent assessments, aside from an in person end of trial visit, will be done via email or telephone together with utilising the routine collected health data thus reducing the burden to participants as well as reducing their exposure to COVID-19.
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