A Study of Micro Dose Ambrisentan in Hospitalized Patients With Respiratory Insufficiency Due to COVID-19
Status:
Recruiting
Trial end date:
2022-10-31
Target enrollment:
Participant gender:
Summary
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.
Subjects 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. Ambrisentan will be administered in the hospital, and will be continued at
home for up to 28 days. In this study, ambrisentan will be administered at much lower doses
that those used in patients with pulmonary hypertension.