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Covid19Phase 1/2NCT04489446

Sildenafil in COVID-19

A Phase 1/2 study testing Sildenafil in people with Covid19 and SARS-COV2 Infection, run by Universidad Nacional Andres Bello at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomised trial aims to assess the role of sildenafil in improving oxygenation amongst hospitalised patients with COVID19. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19, SARS-COV2 Infection
What is being tested?
Sildenafil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChile
Study dates
19 Aug 2020to 30 Jun 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Hospital Naval Almirante Nef

    Viña del Mar, Valparaiso

Other trials in Chile

About this study

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

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

Read the 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 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.

Being tested
Sildenafil, Placebo
Keywords
COVID19, SARS-COV2 Infection, Sildenafil, Phosphodiesterase 5 inhibitors
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SildenafilDrug

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

  • PlaceboDrug

    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.

Study groups in NCT04489446
Study groupRoleWhat they receive
SildenafilExperimentalPatients allocated to this arm will receive Sildenafil 25mg every 8 hours orally for up to seven consecutive days.
Receives: Drug: Sildenafil
ControlPlacebo comparatorPatients 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arterial Oxygenation

    Mean difference in alveolar oxygen pressure to inspired oxygen fraction (Pa/Fi) ratios.

    Measured: One hour after sildenafil administration

  2. Arterial Oxygenation

    Mean difference in alveolar oxygen pressure to inspired oxygen fraction (Pa/Fi) ratios.

    Measured: Daily until the end of follow-up (up to 15 days after randomisation)

  3. Alveolo-arterial gradient

    Mean difference in the alveolo-arterial gradient between study groups.

    Measured: One hour after sildenafil administration

  4. Alveolo-arterial gradient

    Mean difference in the alveolo-arterial gradient between study groups.

    Measured: Daily until the end of follow-up (up to 15 days after randomisation)

Secondary outcomes (4)

  1. Intensive care unit admission

    Proportion of patients requiring admission to an intensive care unit in each study group

    Measured: Up to two weeks after randomisation

  2. Noninvasive Mechanical Ventilation or Requirement of High-Flow Nasal Cannula

    Proportion of patients requiring noninvasive mechanical ventilation o high-flow nasal cannula unit in each study group

    Measured: Up to two weeks after randomisation

  3. Invasive mechanical ventilation

    Proportion of patients requiring invasive mechanical ventilation in each study group

    Measured: Up to two weeks after randomisation

  4. Survival

    Proportion of patients that survived COVID19 in each study group

    Measured: Up to two weeks after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2020
  2. Study start19 Aug 2020
  3. Primary completion30 Apr 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible participants will be randomised to either sildenafil or placebo for up to seven days.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04489446
Sponsor's protocol ID
UNAB-003
Status last verified
Sep 2021
First submitted
25 Jul 2020
Last updated
29 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

    PubMed 32171076

  • Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Jun 25;58(7):1131-1134. doi: 10.1515/cclm-2020-0198. No abstract available.

    PubMed 32119647

  • Santamarina MG, Boisier D, Contreras R, Baque M, Volpacchio M, Beddings I. COVID-19: a hypothesis regarding the ventilation-perfusion mismatch. Crit Care. 2020 Jul 6;24(1):395. doi: 10.1186/s13054-020-03125-9. No abstract available.

    PubMed 32631389

  • Gheblawi M, Wang K, Viveiros A, Nguyen Q, Zhong JC, Turner AJ, Raizada MK, Grant MB, Oudit GY. Angiotensin-Converting Enzyme 2: SARS-CoV-2 Receptor and Regulator of the Renin-Angiotensin System: Celebrating the 20th Anniversary of the Discovery of ACE2. Circ Res. 2020 May 8;126(10):1456-1474. doi: 10.1161/CIRCRESAHA.120.317015. Epub 2020 Apr 8.

    PubMed 32264791

  • Wu Z, Hu R, Zhang C, Ren W, Yu A, Zhou X. Elevation of plasma angiotensin II level is a potential pathogenesis for the critically ill COVID-19 patients. Crit Care. 2020 Jun 5;24(1):290. doi: 10.1186/s13054-020-03015-0. No abstract available.

    PubMed 32503680

  • Santamarina MG, Beddings I, Lomakin FM, Boisier Riscal D, Gutierrez Claveria M, Vidal Marambio J, Retamal Baez N, Pavez Novoa C, Reyes Allende C, Ferreira Perey P, Gutierrez Torres M, Villalobos Mazza C, Vergara Sagredo C, Ahumada Bermejo S, Labarca Mellado E, Barthel Munchmeyer E, Marchant Ramos S, Volpacchio M, Vega J. Sildenafil for treating patients with COVID-19 and perfusion mismatch: a pilot randomized trial. Crit Care. 2022 Jan 3;26(1):1. doi: 10.1186/s13054-021-03885-y.

    PubMed 34980198

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sildenafil in people with Covid19 and SARS-COV2 Infection, run by Universidad Nacional Andres Bello at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arterial Oxygenation (time frame: One hour after sildenafil administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04489446, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.

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Sildenafil in COVID-19 (NCT04489446) | AzTrials