CROWN-CORONATION

International, Bayesian platform adaptive, randomized, placebo-controlled trial assessing the effectiveness of candidate interventions in preventing COVID-19 disease in adults

COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory system. Some people do not have symptoms but can carry the virus and pass it on to others. In 2020, the virus has spread to many countries around the world.

Thus an effective pre-emptive intervention needs to be developed to decrease the occurrence of symptomatic COVID-19, and to mitigate its severity in adults at high risk. Several medications show promise as potential preventative agents for COVID-19 but we do not yet know if any of them will turn out to be effective.

The CROWN CORONATION Trial has been designed to investigate various approaches and to answer two questions: Whether adults who receive the candidate prophylactic agent are at lower risk of developing COVID-19 infection.

Whether adults who do get infected experience a milder disease if they have received the candidate prophylactic agent. In order to answer these questions, we are conducting a large, Bayesian, response adaptive, pragmatic, participant-level randomized, multicentre, transdisciplinary, and international placebo-controlled clinical trial.

Participants will be adults who are considered a vulnerable population due to their high frequency of exposure to people infected with COVID-19. The first approach we are studying is boosting the general immune system by giving a single dose of the measles, mumps and rubella (MMR) vaccine.

Several studies have suggested that as well as boosting immunity to measles, mumps and rubella, this vaccine can give a generalised immunity to viral illnesses. If successful, it could reduce the risk of developing the severe complications of COVID-19. As this is a platform trial, therapeutic arms might be discontinued based on external evidence (from other studies) and internal evidence (generated from this trial).

Additional candidate therapies might be added based on emerging evidence.

Trial status: Closed to recruitment in the UK
Funder: The COVID-19 Therapeutics Accelerator
ISRCTN: ISRCTN 99916292