Biopharmaceutical company is conductiong a study of Micro Dose Ambrisentan in Hospitalized Patients With Respiratory Insufficiency Due to COVID-19

Noorik Biopharmaceuticals AG is starting a new clinical trial of A Study of Micro Dose Ambrisentan in Hospitalized Patients With Respiratory Insufficiency Due to COVID-19.

Patients with COVID-19 frequently develop lower respiratory complications. Difficulty breathing and a low concentration of oxygen in the blood are of concern in patients with COVID-19, as they indicate that the lungs may be significantly affected. In some patients, respiratory symptoms may progress to the point where oxygen support is needed (i.e. use of an oxygen prongs, mask or ventilator).

The exact mechanism of why patients with COVID-19 develop low concentrations of oxygen in blood is not fully understood. Some data suggest that the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the virus causing Coronavirus Disease 2019 (COVID-19), can affect the body's blood vessels directly and extensively. In the lung, blood vessels participate in the absorption of oxygen.

Endothelin is a potent hormone produced by human blood vessels. When increased, endothelin can result in the narrowing of blood vessels in the lung and decrease the volume of blood flowing through the lungs. This decrease in in blood flow through the lungs may be one of many factors affecting normal lung function. Ambrisentan can block the effects of endothelin in the body, and this could theoretically improve blood flow through the lungs.

This study will evaluate whether ambrisentan, by blocking the effects of the hormone endothelin in the lungs, improves the breathing capacity of patients with COVID-19, increases the concentration of oxygen in the blood and prevents the progression to respiratory failure and death. Ambrisentan is a drug that is currently used to treat patients with pulmonary hypertension, a disease where blood flow through the lungs is decreased.

The clinical trial starts in February 8, 2021 and will continue throughout October 31, 2021.

The population that can be enrolled into this study includes the patients  participating in this study are those patients hospitalised with severe respiratory symptoms related to COVID-19, and are considered to be at high-risk of developing respiratory complications.

Among the excluding conditions appear:

• Subject at a high risk of death, according to investigator's opinion, in the 3 months following enrollment from other causes than Acute Respiratory Distress Syndrome (e.g., severe neurological damage or cancer patients in terminal stages of the disease).
• Subject currently being treated with an endothelin receptor antagonist.
• Subject currently being treated with another pulmonary vasodilator.
• Anticipated need for non-invasive mechanical ventilation, endotracheal intubation or tracheostomy at the time of screening.
• History of mechanical ventilation (invasive or non-invasive) in the last 7 days.
• Documented history of end-stage liver disease or cirrhosis.
• Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3-times the upper limit of normal (ULN)

and others.

The contacts and locations are the University Hospital 12 de Octubre, Madrid, Spain.

For more details: https://ichgcp.net/clinical-trials-registry/NCT04771000