Platform Randomised trial of INterventions against COVID-19 In older peoPLE (PRINCIPLE)
Lead Research Organisation:
University of Oxford
Abstract
Abstracts are not currently available in GtR for all funded research. This is normally because the abstract was not required at the time of proposal submission, but may be because it included sensitive information such as personal details.
Publications
Butler CC
(2021)
Doxycycline for community treatment of suspected COVID-19 in people at high risk of adverse outcomes in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial.
in The Lancet. Respiratory medicine
Dorward J
(2022)
Colchicine for COVID-19 in the community (PRINCIPLE): a randomised, controlled, adaptive platform trial
in British Journal of General Practice
PRINCIPLE Trial Collaborative Group
(2021)
Azithromycin for community treatment of suspected COVID-19 in people at increased risk of an adverse clinical course in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial.
in Lancet (London, England)
| Description | Clinical alert to all NHS clinicians informed by findings from the PRINCIPLE Trial. |
| Geographic Reach | National |
| Policy Influence Type | Implementation circular/rapid advice/letter to e.g. Ministry of Health |
| Description | Platform Adaptive trial of NOvel antiviRals for eArly treatMent of covid-19 In the Community (PANORAMIC) |
| Amount | £18,270,088 (GBP) |
| Funding ID | NIHR 135366 |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2021 |
| End | 10/2023 |
| Description | Platform Randomised trial of INterventions against COVID-19 In older peoPLE (PRINCIPLE) |
| Amount | £17,706,579 (GBP) |
| Funding ID | MC_PC_19079 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 03/2020 |
| End | 09/2021 |
| Title | Platform randomised open trial with response adaptive randomisation |
| Description | Principle is one of the first trials ever to use a platform trial design with responsive adaptive randomisation. This allows multiple interventions to be evaluated within the same trial. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | The Lancet paper describing azithromycin treatment for COVID-19 in the community describes the platform trial design. A protocol paper with further information is in press |
| Description | Membership of EU Covid Trial Coordination Baord |
| Organisation | University of Antwerp |
| Country | Belgium |
| Sector | Academic/University |
| PI Contribution | I am a core member the EU TCB that met weekly for most of the pandemic, going then to biweekly and now monthly to discuss and update on Covid related trials both in the EU and internationally. The goal is to harmonise as far as possible and we are appropriate outcome measures for covert trials for comparability ease, and to coordinate around implementation, and new interventions for trials. I attended almost all of the meetings, and they have been over 50 of them. |
| Collaborator Contribution | I represented the Principle and Panoramic trials, as well as contributing around research methods and sharing information about trial design and novel implementation strategies |
| Impact | As a result of these activities, the joint advisory access mechanism to Covid related trials was established. New initiatives have been developed including work on coordinating research efforts across Europe and internationally. |
| Start Year | 2020 |
| Description | RECOVER: |
| Organisation | University of Antwerp |
| Country | Belgium |
| Sector | Academic/University |
| PI Contribution | We contributed to a multidisciplinary research effort that is produced over 60 scientific papers: we focused on qualitative studies and a point prevalence audit survey in 20 countries on the management, presentation, and outcomes of acute respiratory infection during the Covid pandemic |
| Collaborator Contribution | See above |
| Impact | Several peer reviewed publications |
| Start Year | 2020 |
| Description | RECOVER: |
| Organisation | Utrecht University |
| Country | Netherlands |
| Sector | Academic/University |
| PI Contribution | We contributed to a multidisciplinary research effort that is produced over 60 scientific papers: we focused on qualitative studies and a point prevalence audit survey in 20 countries on the management, presentation, and outcomes of acute respiratory infection during the Covid pandemic |
| Collaborator Contribution | See above |
| Impact | Several peer reviewed publications |
| Start Year | 2020 |
| Description | Working with NIHR Clinical Research Network |
| Organisation | National Institute for Health Research |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | The NIHR Clinical Research Network as made an invaluable contributioon in recruiting participants into this national urgent public health trial seeking to identify interventions for use in the community against COVID-19 |
| Collaborator Contribution | We meet with the NIHRCRN national specialty group every two weeks. We meet with a core group also every two weeks. The regions in the CR can promote the research amongst primary care practitioners and help with awareness raising and, critically, recruitment |
| Impact | Please see the paper in the Lancet describing the findings from the principal trial for azithromycin as a treatment for COVID-19. Findings from the principal trial featured in a NIHR clinical alert to all clinicians in the NHS |
| Start Year | 2020 |
| Title | Chief investigator of the PRINCIPLE Trial |
| Description | The principal trial has evaluated azithromycin, and doxycycline. It currently has colchicine and inhaled budesonide in the trial |
| Type | Therapeutic Intervention - Drug |
| Current Stage Of Development | Late clinical evaluation |
| Year Development Stage Completed | 2020 |
| Development Status | Closed |
| Clinical Trial? | Yes |
| Impact | The PRINCIPLE Trial has shown that he is through Meissen and doxycycline are not useful treatments for COVID-19 in the community. This information informed a clinical alert to all NHS clinicians, and is therefore influencing practice and has enhanced the evidence base for the primary care management of the pandemic. |
| Description | Academy of Medical of Medical Sciences report on COVID-19: Preparing for the future-Looking ahead to winter 2021/22 and beyond; Expert Advisory Panel Member. |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Policymakers/politicians |
| Results and Impact | Expert Advisory Group for Academy of Medical of Medical Sciences report on COVID-19: Preparing for the future-Looking ahead to winter 2021/22 and beyond; Expert Advisory Panel Member. |
| Year(s) Of Engagement Activity | 2021 |
| URL | https://acmedsci.ac.uk/policy/policy-projects/covid-19-looking-ahead-to-winter-2021-22-and-beyond |
| Description | European Respiratory Society Congress 2020 virtual talk. |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | The Principal trial was presented and there was great interest in the innovative research methods and progress of the trial: it seems to be the only successful currently active platform randomise control trial in primary care for COVID-19 treatment in the community |
| Year(s) Of Engagement Activity | 2020 |
| Description | European Respiratory Society Congress presentation |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | I presented the design of the principal trial and progress to date at the European Respiratory Society conference as part of a panel, and it was well attended with several questions are |
| Year(s) Of Engagement Activity | 2020 |
| Description | Invited lecture: Platform Randomised trial of INterventions against COVID-19 In older peoPLE (PRINCIPLE): Design and implementation challenges of a national primary care trial of community treatments. ECCMID |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presentation at international conference |
| Year(s) Of Engagement Activity | 2020 |
| Description | PRINCIPLE trial press briefing |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Public/other audiences |
| Results and Impact | As co-Principle Investigator, I was part of a team of 4 attending a press briefing to describ the results of the PRINCIPLE trial - which found that inflaed corticosteroids were of clinical benefit in COVID-19. The press briefing resulted in international news coverage including front page coverage on the BBC. |
| Year(s) Of Engagement Activity | 2021 |
| Description | Platform Trial of community treatment of syndromic COVID-19 like illness- The Principle Trial. Royal College of Edinburgh ;Principle trail presentation: Royal College of Physicians, Edinburgh |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Online webinar on trial design and delivery |
| Year(s) Of Engagement Activity | 2020 |