A Study of Micro Dose Ambrisentan in Hospitalized Patients With Respiratory Insufficiency Due to COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Hypoxemia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 85 years
- Gender
- Both males and females
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 hospitalized subjects who have a confirmed SARS-CoV-2 (a coronavirus (CoV) ) infection, are at high-risk of p...
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 hospitalized subjects who have a confirmed SARS-CoV-2 (a coronavirus (CoV) ) infection, are at high-risk of progression to respiratory failure or death and have low oxygen saturation and/or require oxygen supplementation at the time of admission. Pregnant or lactating women will not be allowed to participate in this study given the teratogenic potential of ambrisentan. Subjects requiring mechanical ventilation or intubation at the time of enrolment are considered to have respiratory failure and will not be allowed into the study, as one primary objective of the study is to evaluate the effect of ambrisentan in preventing respiratory failure. Enrolled subjects will be randomly assigned to the treatment arm or control arm at a 1:1 ratio. In the treatment arm, subjects will receive ambrisentan on top of the standard-of-care. In the control arm, subjects will receive the administration vehicle only (i.e., placebo) and on top of the standard of care. The study medication (ambrisentan or placebo) will be administered for up to 28 days. In the event that the subject is discharged between Day 4 and Day 28, the subject will continue the study treatment at home until completion of the 28-day study medication regimen. Investigators, the Sponsor and the subject will be blinded to the treatment assignment. A Drug Safety Monitoring Board will be monitoring the safety of the study.
Tracking Information
- NCT #
- NCT04771000
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Pilar Escribano Subias, MD University Hospital 12 de Octubre
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