The Use of Tadalafil in Confirmed COVID-19 Pneumonia.

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-04-20

Brief Summary

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

Our goal is to assess the effects of Tadalafil in the setting of confirmed COVID-19 pneumonia. In particular we plan to assess its effects on oxygen saturation, P:F ratio, and mixed central venous oxygen

We plan to recruit all hospitalized patients at Santa Barbara Cottage Hospital with a confirmed COVID19 pneumonia (positive PCR + clinical signs/symptoms of lower respiratory disease) who meet the Berlin definition of ARDS and have access to measure a mixed venous oxygen saturation. For the purposes of obtaining mixed central venous oxygen, all participating patients will already have an internal jugular central venous catheter in place for inclusion in this study. Since all patients will be intubated, their Legally Authorized Representative (LAR) will be approached to discuss the study and asked to participate in the study by an ICU physician, either the attending physician or a medical resident.

Informed consent will be obtained from the LAR by an ICU attending physician or resident involved in the study prior to participation. Patients who meet the above eligibility criteria will have baseline levels of mixed central venous oxygen, oxygen saturation, P:F ratio, blood pressure and PaO2 recorded.

Each patient will then receive Tadalafil 40mg once. The above listed parameters will be monitored again 30 minutes after drug administration and 4 hours after drug administration. No other medication or ventilator changes will be made during this time period outside of emergent changes in the setting of patient deterioration. We will continue to analyze the data in the event of emergent ventilator changes.

Related Clinical Trials

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

Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients

NCT01291069

Single Ventricle

COMPLETED PHASE1

Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension

NCT00730067

COPD Pulmonary Hypertension

WITHDRAWN PHASE4

The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue

NCT01661595

Fatigue

COMPLETED NA

Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension

NCT06350773

Group 2 Pulmonary Hypertension

RECRUITING NA

Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension

NCT00352482

Pulmonary Fibrosis Hypertension, Pulmonary

COMPLETED PHASE2

Detailed Description

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

Conditions

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

COVID Sars-CoV2 ARDS, Human

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will serve as a self-control, with values recorded pre-medication, 30 minutes after medication administration, and 4 hours after administration.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Tadalafil Group

Each patient will be given tadalafil 40 mg one time

Group Type EXPERIMENTAL

Tadalafil Pill

Intervention Type DRUG

Each patient will be given tadalafil 40 mg one time

Interventions

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

Tadalafil Pill

Each patient will be given tadalafil 40 mg one time

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Hospitalized patients at SBCH with confirmed COVID19 pneumonia (PCR + clinical signs/symptoms of lower respiratory disease)
* Patients currently on a ventilator
* Patients who meet the Berlin definition of ARDS
* Patients who have access to measure a mixed venous oxygen saturation (i.e., patients with an internal jugular central venous catheter)
* Patient and/or Legally Authorized Representative is willing/able to provide informed consent

Exclusion Criteria

* As tadalafil is currently a FDA Class B1 medication, indicating that little information is available, pregnant women along with women who are actively breastfeeding will be excluded from this series.
* All patients under 18
* Patients who are routinely taking nitrate medications
* All patients using Tadalafil daily for pulmonary arterial hypertension (Note: patients using Tadalafil intermittently for erectile dysfunction may still participate in the study)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No