Status:
TERMINATED
A Study of Micro Dose Ambrisentan in Hospitalized Patients With Respiratory Insufficiency Due to COVID-19
Lead Sponsor:
Noorik Biopharmaceuticals AG
Conditions:
Covid19
Hypoxemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 indicat...
Detailed Description
This is a randomized, double-blind, placebo-controlled, multi-centre trial to evaluate the safety and efficacy of ambrisentan for the treatment of severe COVID-19. The population consists of hospitali...
Eligibility Criteria
Inclusion
- Subject (or legally authorized representative) provides informed consent (written or oral) prior to initiation of any study procedures.
- Male or non-pregnant, non-lactating female. Women of child-bearing potential must have a confirmed negative serum pregnancy test at the time of screening and must use a highly effective contraceptive method throughout the study (such as implants, injectables, hormonal contraceptives and condom, double barrier contraception \[i.e., condom + diaphragm/spermicidal gel or foam\]) and until one month after completing treatment with the study medication. In the case of hormonal contraception, women should have been on a stable regimen for a minimum of three months before study enrolment. Women not of child-bearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy). Men must use an effective contraception method (i.e., condom + diaphragm/spermicidal gel or foam, or vasectomy), and should not donate semen during the study. Men are considered to be fertile from the time of puberty, except for those men with permanent sterility secondary to bilateral orchiectomy.
- At least 18 years of age and not older than 85 years of age at time of enrolment
- Confirmed SARS-CoV-2 infection defined as: Positive Real-Time Polymerase Chain Reaction (RT-PCR) result in sample collected in the 10 days prior to randomisation, OR positive antigenic test result in sample collected in the 10 days prior to randomisation.
- Radiological confirmation of pneumonia.
- Subject receiving low-flow oxzgen supplementation of at least 2 L/min and not more than 15 L/min.
- Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
- Subject (or legally authorized representative) agrees to not participate in any other clinical trial, including clinical trials for the treatment or prevention of COVID-19 or SARS-CoV-2 through Day 30.
Exclusion
- 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 high-flow oxygen supplementation, 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, cirrhosis or idiopathic pulmonary fibrosis (IPF) with or without pulmonary arterial hypertension.
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 3-times the upper limit of normal (ULN).
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 96 hours.
- Participation in another interventional clinical trial in the 15 days prior to enrollment.
- Known hypersensitivity to ambrisentan or propylene glycol.
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04771000
Start Date
February 8 2021
End Date
February 27 2023
Last Update
March 21 2023
Active Locations (13)
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1
General Hopital Zadar
Zadar, Croatia, 23000
2
University Hospital for Infectious Diseases Fran Mihaljevic
Zagreb, Croatia, 10000
3
Hospital Universitario Virgen de las Nieves
Granada, Comunidad de Andalucia, Spain, 18014
4
Hospital Universitario San Cecilio
Granada, Comunidad de Andalucia, Spain, 18016