PROTECT [COVID-19] [UPH]
Research type
Research Study
Full title
PROphylaxis for paTiEnts at risk of COVID-19 infecTion
IRAS ID
288652
Contact name
Rona Smith
Contact email
Sponsor organisation
Cambridge university Hosptials NHS Foundation Trust and University of Cambridge
Eudract number
2020-004144-28
ISRCTN Number
ISRCTN88057279
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 16 days
Research summary
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.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0403
Date of REC Opinion
23 Oct 2020
REC opinion
Favourable Opinion