COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION. [COVID-19]
Research type
Research Study
Full title
An international, Bayesian platform adaptive, randomised, placebo-controlled trial assessing the effectiveness of candidate interventions in preventing COVID-19 disease in adults.
IRAS ID
282280
Contact name
Laurence Lovat
Contact email
Sponsor organisation
University College London
Eudract number
2020-001402-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
SARS-CoV-2 is a new virus that is at the centre of the current global pandemic and the number of cases in the next 12 months set to likely increase. The virus is new to humans and thus the development of a vaccine to help protect at risk populations such as front line medical staff is at least 12 to 18 months away. Therefore, front line medical staff are at risk of contracting this potentially deadly disease. Thus an effective pre-emptive intervention needs to be developed to decrease the occurrence of symptomatic COVID-19, and to mitigate its severity in front line medical staff, while a vaccine is developed. \n\nThere is growing evidence suggesting that Chloroquine, an anti-malarial drug that has been in common use for the last 70 years, that is a broad-spectrum anti-viral medication which, through its mode of action could potentially prevent the development of severe COVID-19 symptoms. \n\nHowever, despite the potential benefit, due to immunosuppressant proprieties of chloroquine, there is the risk that this medication may increase the risk of COVID-19 and other infections, so widespread adoption should be approached with caution. \n\nCROWN CORONATION is an international phase III trial in healthcare workers at risk of contracting COVID-19, investigating the use of chloroquine or hydroxychloroquine (in countries where malaria is not endemic and more readily available than chloroquine) to prevent the development of symptomatic COVID-19, mitigate the severity of symptoms and to find the minimum effective dosing schedule of chloroquine or hydroxychloroquine to prevent symptomatic COVID-19 in at risk healthcare workers. \n\nThe CROWN CORONATION trial is a double blind, randomised trial consisting of 4 treatment arms: Low Dose (400mg hydroxychloroquine sulphate weekly); Medium Dose (400mg hydroxychloroquine sulphate twice weekly); High Dose (200mg hydroxychloroquine sulphate daily); Placebo (equivalent for each of these in the placebo arm).\n
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0116
Date of REC Opinion
30 Apr 2020
REC opinion
Further Information Favourable Opinion