Trial of COVID-19 Home Treatments for Over-50s Set to Be Widened 

Peter Russell

October 29, 2020

Early results from a trial of low-risk treatments to slow or halt the progression of COVID-19 in older people and prevent the need for hospital admission could be released within weeks, researchers said.

The team, from the University of Oxford, behind the PRINCIPLE (Platform Randomised trial of INterventions against COVID-19 In older peoPLE) trial said they were hoping to recruit more participants with early symptoms of COVID-19 who were over 65, or over 50 with an underlying health condition.

They are also considering extending the trial to include younger people to test treatments that could help those who experience longer-term symptoms after contracting COVID-19 in a condition known as 'long COVID'.

Researchers briefed medical journalists on Wednesday in a webinar hosted by the Science Media Centre.

They are currently evaluating:

PRINCIPLE began in April 2020, evaluating hydroxychloroquine. Although this arm of the trial was suspended in June 2020 because of disappointing results among hospitalised patients with COVID-19, results from the drug used in a community setting are set to emerge soon.

"We have permission now from the trial steering committee to release those data," said Chris Butler, trial co-lead, and professor of primary care at the Nuffield Department of Primary Care Health Services.

"It was suspended before we had reached our target sample … but we will be putting those results in the public domain, hopefully within weeks," he confirmed.

Trial Aims to Reduce Hospital Admissions

It will be a longer wait to hear how effective the two antibiotics currently under investigation might be among this older cohort.

Both drugs under evaluation are used to treat certain bacterial infections, including some chest and skin infections.

Invitro studies "suggest that azithromycin increases the pH level within parts of human cells, interfering with the ability of the SARS-CoV-2 virus – the virus that causes COVID-19 – to bind to human cells, as well as interfering with its ability to replicate and spread within human cells", explained Dr Kome Gbinigie, a GP and trial co-investigator.

"There are computer modelling studies as well that suggest that doxycycline may also have activity against the SARS-CoV-2 virus," she said, and "both drugs may additionally reduce the production by the body of small proteins called cytokines", reducing high and damaging levels of inflammation.

The researchers are also investigating whether antibiotics in the trial could reduce occurrence of a secondary bacterial pneumonia in older people with COVID-19.

A total of 1446 participants have been recruited to the trial since inception with the help of 1000 GP practices. The researchers are hoping to enrol more people, particularly in areas of the country with higher rates of the novel coronavirus.

Scope of Trial Could Be Extended to Include Long COVID

They are also considering extending the trial to other treatments as well as broadening its scope to include younger age groups in light of growing evidence that the virus can cause persistent and recurring symptoms.

"The issue of long COVID might be something that really compels us to look at a broader range of inclusion and to see whether the interventions are effective in reducing these other adverse outcomes from COVID," said Prof Butler.

He also cautioned that despite current efforts to develop a vaccine to protect against COVID-19, "it's unlikely that we will find a perfect vaccination that will protect everybody 100%, so finding treatments in therapeutic trials that are also beneficial will continue to be important".

PRINCIPLE is classified as an urgent public health study and has been endorsed by the chief medical officers of all four UK nations.

The trial is funded from UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research.

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