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Covis Pharma has launched a Phase III clinical trial to evaluate its asthma drug Alvesco (ciclesonide) for the treatment of non-hospitalised, symptomatic Covid-19 patients aged 12 years and above.
The company, which is based in Luxembourg with operations in Zug, Switzerland, secured the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application of the drug to treat Covid-19.
Designed to assess the drug’s safety and efficacy, the multi-centre, randomised, double-blind, placebo-controlled trial commenced patient enrolment.
Alvesco is an inhaled glucocorticoid indicated as maintenance therapy for the long-term treatment of asthma in adults and adolescents aged 12 years and older in the US and over six years in Canada.
In Covid-19 patients, the drug is expected to decrease symptoms and suppress viral replication.
The drug is currently being investigated for treating Covid-19 in multiple countries such as Australia, Japan, South Korea, Sweden, the UK and the US. The company is working to ensure the appropriate supply of Alvesco for these clinical studies.
Covis Pharma Regulatory and Scientific Affairs executive vice-president Aziza Johnson said: “Early scientific data suggest that the use of Alvesco may reduce symptoms in individuals with the novel coronavirus, potentially decreasing viral replication and therefore viral load.
“Given the urgent need for treatment options, we are working with expediency to assess the efficacy of Alvesco against Covid-19 and believe this study will provide us with important data around the drug’s ability to reduce duration of clinical symptoms, as well as the severity of the disease.”
For the Phase III trial in the US, approximately 400 patients will be recruited at several sites across the country. Participants will be given 320µg of Alvesco metered-dose inhaler twice daily along with standard supportive care or placebo plus standard supportive care.
The primary endpoint is the percentage of patients with a hospital admission or death by day 30. Early data are expected to be available in late-August/early-September this year.