Status:
COMPLETED
Sildenafil in COVID-19
Lead Sponsor:
Universidad Nacional Andres Bello
Collaborating Sponsors:
Hospital Naval Almirante Nef, Viña del Mar, Chile
Conditions:
Covid19
SARS-COV2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This randomised trial aims to assess the role of sildenafil in improving oxygenation amongst hospitalised patients with COVID19.
Detailed Description
Perfusion anomalies, namely hypoperfusion of healthy lung and vasoplegia with hyperperfusion of diseased lung areas, have been recently described amongst patients with COVID19. In this triple-blind pi...
Eligibility Criteria
Inclusion
- Adult participant with high clinical suspicion of a SARS-CoV2 infection.
- Hypoperfusion of healthy lung areas in a substraction computed tomography angiography within 24 hours of admission to the hospital.
Exclusion
- Requirement of therapy with nitrates of nitrites
- Arterial hypotension at presentation
- Recent diagnosis of coronary artery disease (\<6 months)
- Acute heart failure at presentation
- Recent stroke (\< 6 months)
- Chronic respiratory failure with CO2 retention
- Known hypersensitivity to sildenafil
- Advanced liver disease (Child-Pugh class B or higher)
- Users of cytochrome P450 3A4 inhibitors (Erythromycin, Ketoconazole, Itraconazole, Saquinavir)
- Pulmonary hypertension
- Chronic users of phosphodiesterase 5 inhibitors
- Requirement of invasive mechanical ventilation at baseline
- Decision to limit therapeutic efforts at baseline
- Pregnancy or lactation
- History of retinitis pigmentosa
- Known obstruction to left-ventricular outflow tract
- Unwillingness to participate in the trial
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04489446
Start Date
August 19 2020
End Date
June 30 2021
Last Update
September 29 2021
Active Locations (1)
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1
Hospital Naval Almirante Nef
Viña del Mar, Región de Valparaíso, Chile