Results
Thank you for your interest in the PRINCIPLE Study.
The study stopped recruitment in July 2022, and we have been continuing to collect the data we need for the analysis of the Ivermectin and Favipiravir arms of the trial since this date. As a result, we have not yet published the results for these two treatments. Participants in the trial are followed up for a full year, so that we are able to answer the critically important questions about the effect of treating acute SARS-Cov-2 infection on symptoms and well-being over the longer term. We will be uniquely paced to provide data on possible impact on longer term symptoms.
The team are currently working hard on collecting the one year follow up data which should be complete by the end of July 2023. Once data collection is compete, queries still need to be made, and the data will still needs to be fully cleaned and the subject to complex analyses. We are committed to doing this in the most rigorous and transparent way according to our published protocol.
Please be assured that you will be able to find the results on this page as soon as they become available, and we will submit scientific papers describing this rigorous, independent evaluation of these medicines to peer reviewed journals as soon as possible.
Inhaled budesonide
Summary:
Early treatment with inhaled budesonide shortens recovery time by a median of three days in patients with COVID-19 who are at higher risk of more severe illness and are treated in the community. A common corticosteroid, budesonide is the first widely available, inexpensive drug found to shorten recovery times in COVID-19 patients aged over 50 who are treated at home and in other community settings. The findings are based on an interim analysis, which included 751 people in the budesonide group and 1028 in the usual care group who were SARS-CoV-2 positive.
Research paper:
PRINCIPLE Trial Collaborative Group
The Lancet, August 10, 2021: DOI: https://doi.org/10.1016/S0140-6736(21)01744-X
Press release:
Asthma drug budesonide shortens recovery time in non-hospitalised patients with COVID-19
UK therapeutic alert:
12 April 2021
Azithromycin
Summary:
Azithromycin is not generally an effective treatment for reducing the time to recovery or risk of hospital admission for people with suspected COVID-19 in the community. The analysis included data from 500 patients assigned to receive azithromycin and usual NHS care, who were compared with 823 patients who were assigned to usual NHS care only.
Research paper:
Azithromycin for community treatment of suspected COVID-19 in people at increased risk of an adverse clinical course in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial
PRINCIPLE Trial Collaborative Group
The Lancet, March 4 2021. DOI: https://doi.org/10.1016/S0140-6736(21)00461-X
Azithromycin and doxycycline are not generally effective against COVID-19 in patients treated at home, shows PRINCIPLE trial
January 25, 2021
UK therapeutic alert:
Doxycycline
Summary:
Doxycycline is not generally an effective treatment for reducing the time to recovery or risk of hospital admission from COVID-19. The finding is based on an interim analysis of 798 patients assigned to receive doxycycline and usual NHS care who were compared with 994 patients assigned to receive usual NHS care only.
Research Paper:
PRINCIPLE Trial Collaborative Group
Lancet Respir Med , July 27 2021.
DOI: https://doi.org/10.1016/ S2213-2600(21)00310-6
Press release:
Azithromycin and doxycycline are not generally effective against COVID-19 in patients treated at home, shows PRINCIPLE trial
January 25, 2021
UK therapeutic alert:
Colchicine
Summary:
Colchicine did not improve time to recovery in people at higher risk of complications with COVID-19 in the community. The analysis included data from 156 patients assigned to receive Colchicine and usual NHS care, who were compared with 1145 patients who were assigned to usual NHS care only, and 1454 to other treatments.
Research Paper:
PRINCIPLE Trial Collaborative Group
medRxiv , September 23 2021.