Background

COVID-19 is a rapidly progressing viral infection pandemic that continues to afflict millions of Canadians and Americans. No effective therapy in non-hospitalized patients or vaccine has yet been found to prevent complications of COVID-19. While most patients with COVID-19 have a mild condition with a favourable outcome, older adults and those with chronic underlying medical conditions are at an increased risk of developing lung complications that require hospitalization. Some patients may develop severe breathing difficulties that require admission to the intensive care unit and ventilator support. Neither Health Canada nor the United States Food and Drug Administration has yet approved any medications for the treatment of COVID-19 patients prior to hospitalization when the signs of infection first appear, with the potential to prevent the need for hospitalization.

Purpose

The DAP-CORONA RCT study proposes early prophylactic intervention with an existing generic molecule among non-hospitalized, SARS-CoV-2 (novel coronavirus) positive individuals at high-risk for COVID-19 complications (elderly and adults with comorbidities) manifesting COVID-19 symptoms. This generic molecule is approved for many other indications. The purpose of the study is to assess whether this early intervention with the study-drug is effective against complications that may arise in the infected high risk patients with COVID-19 symptoms and specifically, whether it will reduce the need for hospitalization in this patient group.

The intervention has been approved for use in this research study by Health Canada or the US-FDA and this study is the first randomized controlled trial to inform use of this intervention for treatment for COVID-19.

Study

Individuals above the age of 40 years, having medical symptoms that are related to COVID-19 will be invited to contact us and join the study. At this stage individuals may or may not have their COVID-19 test result. The trial team will contact these individuals to screen for those that will meet the trial eligibility criteria. All details of inclusion and exclusion criteria for eligibility will be found here.

 

Up to 2,100 volunteers meeting the eligibility criteria will participate in the study, which is coordinated by a team of clinical MD/PhD specialists at a total of six study sites, two in Canada (Quebec and Ontario) and four in the United States (Arizona, California, Florida and Pennsylvania).

 

Eligible participants will be randomized to receive intervention or placebo for a duration of 21 days and will be closely (remotely) monitored for COVID-19 symptoms and treatment side-effects for a total duration of 28 days. Participants will also be supported throughout their participation by the study team and the team will be readily accessible to the participants during this period through virtual visits/calls.