Clinical Trials to evaluate effectiveness of anti-malarial drug, hydroxychloroquine (HCQ) and antibiotic, Azithromycin in treating older people with COVID-19 begins in the UK and USA with an aim to reducing the severity of symptoms and avoiding hospitalization
Of late, there have been several unconfirmed reports of effectiveness of commonly available drugs particularly anti-malarial drug, hydroxychloroquine in dealing with the symptoms of COVID-19. However, there are no evidence so far to support such repurposing of pre-existing drugs in any setting.
As part of UK government’s COVID-19 rapid response and funded by UKRI (UK Research and Innovation) and the DHSC (Department of Health and Social Care) through NICE (National Institute for Health Research), The PRINCIPLE Trial has begun recruiting two groups of people – ‘people aged 50–64 with a pre-existing illness’, or ‘aged 65 and over’, into the trial.
The term ‘PRINCIPLE’ stands for Platform Randomised trial of Interventions against COVID-19 in older peoPLE.
The PRINCIPLE trial is testing pre-existing drugs for older patients in the community who show signs of the disease. Pre-screening of older coronavirus patients can be done online via an online questionnaire to see whether they can be included. The idea behind PRINCIPLE trial is to help elderly people with COVID-19 symptoms get better quickly and stop them needing to go to hospital, thereby reducing the burden on NHS.
In the United States, National Institute of Allergy and Infectious Diseases (NIAID), has started to enrol adults with mild to moderate symptoms of SARS-CoV-2 infection in a 2000 patients Phase 2b clinical trial to begin evaluating the anti-malaria drug hydroxychloroquine, together with the antibiotic azithromycin, for preventing hospitalization and death from COVID-19.
The key idea behind these trials is to find out whether these two drugs can prevent hospitalization and death due to COVID-19 and whether this experimental treatment is safe and tolerable.
1. 1. UK Research and Innovation 2020. News – COVID-19 drugs trial rolled out across UK homes and communities. Posted 12 May 2020. Available online at https://www.ukri.org/news/covid-19-drugs-trial-rolled-out/ Accessed on 14 May 2020.
2. Nuffield Dept of Primary Care Health Sciences 2020. The PRINCIPLE Trial. Available online at https://www.phctrials.ox.ac.uk/principle-trial/home Accessed on 14 May 2020.
3. NIH, 2020. News releases – NIH begins clinical trial of hydroxychloroquine and azithromycin to treat COVID-19. Posted 14 May 2020. Available online at https://www.nih.gov/news-events/news-releases/nih-begins-clinical-trial-hydroxychloroquine-azithromycin-treat-covid-19 Accessed on 15 May 2020.