A new clinical trial has been launched in the UK to study pre-existing drugs as potential Covid-19 therapies in people aged more than 50 years with signs of the infection.
Led by the University of Oxford, the PRINCIPLE trial aims to prevent the development of more serious coronavirus symptoms in the patient population. It will assess the drugs’ ability to slow or halt the disease progression and prevent hospital admission.
PRINCIPLE is said to be the first Covid-19 trial to be conducted in a primary care setting.
More than 500 GP practices started enrolling individuals aged 50 and above with underlying health conditions, or those aged above 65 irrespective of their underlying health conditions.
The trial is also screening online, allowing elderly people with coronavirus symptoms to pre-screen at home via an online questionnaire to check their eligibility.
Multiple low-risk treatments will be compared to the existing best available care during the study.
Initially, the trial is assessing a seven-day course of hydroxychloroquine for its ability to mitigate the severity of symptoms in vulnerable groups and help prevent hospitalisation. Antibiotic azithromycin will soon be added to the study.
Trial chief investigator Chris Butler said: “The PRINCIPLE trial platform is enabling us to rapidly evaluate potential treatments for Covid-19 in older people who are most at risk of serious complications from the illness.
“With enough people recruited, this trial will give us the vital information we need to understand whether existing drugs can help people recover sooner and at home, without needing to be admitted to hospital, a significant milestone in the course of this pandemic.”
Participants will be tracked for the first 28 days of the trial. A health record notes review will be performed for up to three months to gain insights into the longer-term effects of the disease.
The PRINCIPLE trial platform has secured £1.7m from UK Research and Innovation (UKRI) and the Department of Health and Social Care.