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Results

Thank you for your interest in The PRINCIPLE Trial.

The Trial stopped recruitment in July 2022. Participants in the trial were followed up for a full year, so that we could answer 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. 

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.

If you would like to see the full Trial Protocol please click here:

You can also read our comprehensive PRINCIPLE Trial Explainer "Understanding the PRINCIPLE Trial: A Guide for Patients and the Public"  which provides a plain-language overview of this groundbreaking COVID-19 clinical study, its methods, findings, and the rigorous scientific process behind evaluating potential treatments.

Favipiravir

Summary:

Favipiravir, an anti-viral, moderately shortened recovery time but did not reduce hospital admission or other long term outcomes in a vaccinated population.

Ivermectin

Summary:

 Ivermectin is a medication commonly used to treat parasitic worms and other parasitic infections that also has some anti-inflammatory effects. In this largely vaccinated population of participants with confirmed cases of COVID-19, there was no differences in hospital admission, a modest reduction in first-reported time to recovery (from 16 to 14 days), and no impact on work or studies at three, six and 12 months. The analysis included 2,157 participants receiving ivermectin plus usual NHS care, compared with 3,256 participants receiving usual NHS care alone.

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.

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. 

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. 

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.