RI-MUHC researchers initiate a clinical trial of ciclesonide to possibly prevent mild cases of COVID-19 from worsening
Montreal, September 16, 2020 – Steroid drugs are anti-inflammatory medicines that are used to treat a wide range of conditions, and one of them – oral or intravenous dexamethasone – was found effective in improving the survival of patients with severe COVID-19. Could other drugs from the same family show potential to treat milder cases of COVID? A team of researchers at the Research Institute of the McGill University Health Centre (RI-MUHC) believes so. On September 14, 2020, they started testing the efficiency of ciclesonide, an inhaled and nasal steroid drug currently used for asthma and nasal rhinitis. Laboratory studies have already shown that treatment with ciclesonide can decrease viral replication of SARS-Cov2, the virus responsible for the disease. This placebo-controlled randomized trial will confirm if the administration of inhaled and nasal ciclesonide can reduce the severity of respiratory symptoms among mild cases of COVID-19 and potentially avoid the need for hospitalization and oxygen.
“We know the COVID-19 virus starts by multiplying in the nose and progresses downwards to the lower parts of the airways and lungs. We hope that targeting the site of viral replication with inhaled and nasal ciclesonide will reduce early viral replication and decrease severity of COVID-19 illness,” says the principal investigator in this study, Dr. Nicole Ezer, who is a junior scientist in the Translational Research in Respiratory Diseases Program at the RI-MUHC and an assistant professor in the Department of Medicine at McGill University.
Approved by Health Canada in 2008 and regularly prescribed by family doctors and lung specialists, ciclesonide deposits in the nose and lung and acts locally without entering the blood system. It has relatively few and mild side effects that disappear when the drug is stopped. The most common one is oral thrush (candida); which occurs in less than one percent of patients and can be avoided by using an aero-chamber.
“We believe that some individuals may benefit from a treatment option such as this one, which does not have significant side effects, does not interact with other medications and is used topically,” says Dr. Ezer.
The study enrolls adults diagnosed with COVID-19 fewer than 5 days prior to enrollment and residing anywhere in Quebec, who are not hospitalized and who show symptoms of COVID-19 such as shortness of breath, cough, nasal irritation, lack of smell, fatigue and diarrhea. Participants are randomly assigned the study drug or placebo in the form of an inhaler and nasal spray, which they receive to their home address by courier. The trial requires 454 participants to be enrolled.
This study is funded by the McGill Interdisciplinary Initiative in Infection and Immunity (MI4) with seed funding from the McGill University Health Centre Foundation.
Investigational drug for the study has been donated by COVIS pharma.