Sildenafil in COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-19

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomised trial aims to assess the role of sildenafil in improving oxygenation amongst hospitalised patients with COVID19.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Pilot Study of Sildenafil in COVID-19

NCT04304313

COVID-19

UNKNOWN PHASE3

VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension

NCT01889966

Pulmonary Hypertension Associated With Connective Tissue Disease

COMPLETED PHASE4

Sildenafil Impact on Ventricular Function in Patients With Heart Failure

NCT01936350

Heart Failure

COMPLETED PHASE2/PHASE3

Hemodynamic Response After Six Months of Sildenafil

NCT00483626

Pulmonary Arterial Hypertension

UNKNOWN PHASE4

Copd Exacerbation and Pulmonary Hypertension Trial

NCT04538976

Acute Exacerbation of COPD

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 SARS-COV2 Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible participants will be randomised to either sildenafil or placebo for up to seven days.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sildenafil

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

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

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

Control

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sildenafil

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No