The Use of Tadalafil in Confirmed COVID-19 Pneumonia.

June 30, 2021 updated by: Santa Barbara Cottage Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tadalafil Group
Each patient will be given tadalafil 40 mg one time
Drug: Tadalafil Pill
Each patient will be given tadalafil 40 mg one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in P:F ratio
Time Frame: Pre-medication, 30 minutes post medication, 4 hours post-medication
Change in a patient's P:F ratio after medication administration
Pre-medication, 30 minutes post medication, 4 hours post-medication
Improvement in oxygen saturation
Time Frame: Pre-medication, 30 minutes post medication, 4 hours post-medication
Change in oxyhemoglobin as noted on an arterial blood gas sample after medication administration
Pre-medication, 30 minutes post medication, 4 hours post-medication
Improvement in partial pressure of oxygen in the bloodstream
Time Frame: Pre-medication, 30 minutes post medication, 4 hours post-medication
Change in oxygen partial pressure (aka PaO2) as noted on an arterial blood gas sample after medication administration
Pre-medication, 30 minutes post medication, 4 hours post-medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santa Barbara Cottage Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

April 20, 2020

Study Completion (Actual)

April 20, 2020

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-63mrx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID

Clinical Trials on Tadalafil Pill

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe