Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04946162

The Use of Tadalafil in Confirmed COVID-19 Pneumonia.

Status
Withdrawn
Phase
Phase 4
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Santa Barbara Cottage Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGTadalafil PillEach patient will be given tadalafil 40 mg one time

Timeline

Start date
2020-04-20
Primary completion
2020-04-20
Completion
2020-04-20
First posted
2021-06-30
Last updated
2021-07-02

Source: ClinicalTrials.gov record NCT04946162. Inclusion in this directory is not an endorsement.