In primary care, the 'national priority' COVID-19 clinical trial is the PRINCIPLE trial, which will start by evaluating hydroxychloroquine against standard care in higher-risk patients. Recruitment is initially taking place in the 500+ practices that are part of the RCGP's Research and Surveillance Centre Network. Practices interested in joining the study can email firstname.lastname@example.org to sign up.
To be eligible for enrolment, patients must have symptoms of possible COVID-19 (continuous cough and/or high temperature) that started within the last 7 days, and be either aged 65 and over, or aged 50 and over with the following: weakened immune system due to serious illness or infection (eg, chemotherapy), heart disease, asthma or lung disease, diabetes not treated with insulin, mild hepatic impairment, or stroke or neurological problem.
To begin with, participants will be randomly allocated to receive standard care, or hydroxychloroquine 200mg twice daily plus standard care, for 7 days. However, the 'platform' design of the study allows additional interventions to be incorporated over time if promising new candidates are identified. All participants will receive a swab kit to take their own sample, and will be told if the swab is positive or not for COVID-19. The investigators aim to recruit at least 3000 participants.
Attention has focused on hydroxychloroquine as a possible treatment for COVID-19 after unpublished data were reported by a group of French investigators suggesting it could shorten the course of the disease. However, other experts have criticised the group's findings.
The CMOs say the faster that patients are recruited, the sooner reliable results will be obtained. While they acknowledge it is for every individual clinician to make prescribing decisions, they say they 'strongly discourage' use of off-licence treatments outside of a trial. Use of treatments outside of a trial, when participation was possible, is a 'wasted opportunity' to generate information that will benefit others, they warn.
They add: 'Any treatment given for coronavirus other than general supportive care, treatment for underlying conditions, and antibiotics for secondary bacterial complications, should currently be as part of a trial, where that is possible.'
The letter says COVID-19 trials are essential to the future treatment of UK and global patients and are being run 'as simply as they can be' to reduce the burden on the NHS. Important results will be disseminated rapidly to improve clinical practice, it adds.