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Introduction

You are invited to take part in the CLARITY trial because you have recently been found to have the virus causing COVID-19.

The COVID-19 virus can cause a respiratory infection. Its symptoms include fever, coughing and sore throat. Most people with COVID-19 only have a mild illness, however, in some cases, the illness can be more severe and include symptoms like difficulty breathing. There is no proven treatment for COVID-19 but medical care can manage most of the symptoms while your body fights the infection.

Angiotensin Receptor Blockers (ARBs) are a group of medications that have been widely used for over 20 years in Australia. They are an existing medication used to treat conditions including high blood pressure, kidney disease and heart disease. ARBs may be able to limit the effect of the COVID-19 virus on the body. This is because the COVID19 virus changes normal body processes to infect lung cells and then promotes inflammation in the lung tissue. Both of these negative effects may be partially blocked by ARBs.

There has been speculation about the role of ARBs in COVID-19 infections, and whether they may be harmful or helpful in limiting the infection and its consequences. The grounds for these suggestions are theoretical and, at present, no clinical studies have shown an effect of these drugs on COVID-19. If you would like further information, please speak to your treating doctor or study doctor.

This study aims to assess whether ARBs will reduce the severity of infection, in people diagnosed with COVID-19. The trial will continue to recruit participants until there is enough evidence to say whether this is true or not.

Read the information below carefully and ask the study team about anything you do not understand or want to know more about. Before deciding whether or not to take part, you might want to talk about it with a relative or friend. 

Medications, drugs and devices have to be approved for use by the Australian Federal Government. The drugs used in this study are an experimental treatment for COVID-19. This means that they are not currently approved for COVID-19 treatment in Australia.  This study will be conducted under the Therapeutic Goods Administration (TGA) Clinical Trials Notification (CTN) Scheme. This allows the investigators to use these products for medical research purposes once the research has been assessed and approved by an authorised Human Research Ethics Committee (HREC).