PROTECT [COVID-19]
Research type
Research Study
Full title
“PROphylaxis for paTiEnts at risk of Covid-19 infecTion (PROTECT): a basket trial of prophylactic interventions amongst at-risk patients.
IRAS ID
282317
Contact name
Thomas Hiemstra
Contact email
Sponsor organisation
Cambridge university Hosptials NHS Foundation Trust and University of Cambridge
Eudract number
2020-002016-48
ISRCTN Number
ISRCTN88057279
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 0 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 treat or delay progression of COVID-19 and no vaccine is yet available. 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 Basket clinical trial aims to enrol patients at particularly high risk of COVID-19 and its complications, seeking to test treatments that either might prevent the disease from occurring or may reduce the number of cases where the disease becomes serious or life-threatening. The PROTECT trial will use innovative design and analysis methodologies to allow the simultaneous assessment of one or more treatments in multiple populations.
Patients will be eligible for recruitment to the trial if they fall within one of the following vulnerable populations: a)patients receiving haemodialysis, b)transplant patients, c)patients with vasculitis, d)other disease areas involving vulnerable patients.
PROTECT will use an innovative basket design to carry out a series of prospective, randomised comparisons in multiple vulnerable patient groups in the UK. Once consented, eligible participants will be randomised to active treatment or control, stratified by PROTECT subpopulation (disease specific). Enrolment to the trial will be via an online platform and following informed consent subsequent assessments will be done via email or telephone thus reducing the burden to participants as well as reducing their exposure to COVID-19.
The master PROTECT protocol describes core components that are shared between disease specific appendices to the core protocol.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0146
Date of REC Opinion
19 May 2020
REC opinion
Favourable Opinion