Platform Randomised trial of INterventions against COVID-19 In older peoPLE

The first clinical trial in COVID-19 patients consulting their GP will test if the anti-malarial drug hydroxychloroquine or the antibiotic Azithromycin can reduce the need for people to go to hospital or speed up their recovery. They will recruit patients

Status: Primary Care, Open and Recruiting.

Type: Interventional

Funder: UKRI / NIHR

Sponsor: University of Oxford

CI: Christopher Butler

IRAS-Number: 281958

CPMS-ID: 45457

Study Website: TBC

Inclusion/Exclusion:

  • Inclusion
    • Participant is willing and able to give informed consent for participation in the study.
    • Participant is willing to comply with all trial procedures.
    • Onset of symptoms of possible COVID-19 in the community (continuous cough and/or high temperature) within 7 days of inclusion.
    • Patients aged > = 50-64 years with any of the following listed comorbidities:
      • known weakened immune system due to a serious illness or medication (e.g. chemotherapy)
      • known heart disease
      • known asthma or lung disease
      • known diabetes not treated with insulin
      • known mild hepatic impairment
      • known stroke or neurological problem;
    • OR • Patients aged > = 65 with or without comorbidity. 
  • Exclusion
    • Pregnancy.
    • Breastfeeding.
    • Known severe hepatic impairment.
    • Known severe renal impairment.
    • Known acute porphyrias.
    • Type 1 diabetes or insulin dependent Type 2 Diabetes mellitus.
    • Known G6PD deficiency.
    • Known myasthenia gravis.
    • Known severe Psoriasis.
    • Known severe neurological disorders (especially those with a history of epilepsy may lower seizure threshold).
    • Previous adverse reaction to, or currently taking, hydroxychloroquine.
    • Known retinal disease.
    • Judgement of the recruiting clinician deems ineligible.  

Description:

COVID-19 disproportionately affects people over 50 years old with comorbidities and those over 65 years old. The infection causes considerable morbidity and mortality in this population group in particular, and is having a devastating effect on people’s health and society internationally. So far, there are no treatments for COVID-19 that have been proven in rigorous clinical trials to be effective. It is essential to identify interventions that may favourably modify progression of the infection. An ideal intervention would one that is safe, with few side-effects, helps prevent disease progression, and can be administered in the community using existing NHS processes and capability.

We propose establishing a platform randomised controlled trial in primary care that can be rapidly deployed to evaluate low risk interventions for high risk people. In the first instance this platform will evaluate a drug called hydroxychloroquine. This is a drug that is already available within the NHS but that has not been subject to randomised controlled trials for this indication in Europe or in community healthcare settings with the aim of reducing the need for hospital assessment.

Using a simple, streamlined open trial design, with procedures embedded in existing health service structures and capabilities, our trial aims to give a rapid answer about the effectiveness of trial treatments in modifying the disease course. The goal is to prevent disease progression such that affected individuals will recover sooner, but critically, avoid the need for hospital assessment and admission. The platform trial will be flexible in that it will operate under a master protocol that will allow the addition of further interventions into the trial while it is in progress, should such suitable interventions become available.

The trial will be implemented in the first instance by the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) general practices.