Trial | NCT04489446  Report issue

Title

Sildenafil in COVID-19
Sildenafil for Treating Patients With COVID-19 and Perfusion Mismatch: A Pilot Randomised Trial

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
This randomised trial aims to assess the role of sildenafil in improving oxygenation amongst hospitalised patients with COVID19.
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 pilot randomised trial, adult patients with high clinical suspicion of SARS-CoV2 infection and perfusion defects in a substraction computed tomography angiography will be randomised in a 1:1 ratio to receive sildenafil or placebo. Informed consent will be obtained from every included participant. Patients requiring mechanical ventilation at baseline will be excluded, as will those who present a contraindication to sildenafil, previous users of sildenafil, those requiring therapy with nitrates, patients in which an order to limit therapeutic efforts has been issued, pregnant or breastfeeding women and those who decline to participate in this study. The primary outcome for this trial wil be oxygenation changes in blood gas analyses. Secondary outcomes will include clinical deterioration requiring admission to an intensive care unit, requirement of high-flow nasal cannula or invasive mechanical ventilation and overall survival. Patients will be followed-up until hospital discharge or up to fifteen days after randomisation. Statistical analyses will be undertaken by a statistician unaware of treatment allocation under the intention-to-treat principle.
Study Started
Aug 19
2020
Primary Completion
Apr 30
2021
Study Completion
Jun 30
2021
Last Update
Sep 29
2021

Drug Sildenafil

Patients allocated to this arm will receive Sildenafil 25mg every 8 hours orally for up to seven consecutive days.

Drug Placebo

Patients allocated to this arm will receive a matching placebo similar to Sildenafil pills used in the intervention arm. Placebos will be delivered orally every 8 hours for up to seven consecutive days.

Sildenafil Experimental

Patients allocated to this arm will receive Sildenafil 25mg every 8 hours orally for up to seven consecutive days.

Control Placebo Comparator

Patients allocated to this arm will receive a placebo that will be similar in form to sildenafil pills in the interventional arm. These doses will be scheduled every 8 hours and wil be administered orally por up to seven consecutive days.

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted