View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
May 20, 2020updated 12 Jul 2022 11:48am

Covis Pharma studies asthma drug Alvesco for Covid-19

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.

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.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena