Clincosm LogoSign in Get a demo

The Use of Tadalafil in Confirmed COVID-19 Pneumonia.

Sponsor
Santa Barbara Cottage Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04946162
Collaborator
(none)
0
Enrollment
1
Arm

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tadalafil Pill
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Participants will serve as a self-control, with values recorded pre-medication, 30 minutes after medication administration, and 4 hours after administration.Participants will serve as a self-control, with values recorded pre-medication, 30 minutes after medication administration, and 4 hours after administration.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Use of Tadalafil in Confirmed COVID-19 Pneumonia.
Actual Study Start Date :
Apr 20, 2020
Actual Primary Completion Date :
Apr 20, 2020
Actual Study Completion Date :
Apr 20, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Improvement in P:F ratio [Pre-medication, 30 minutes post medication, 4 hours post-medication]

    Change in a patient's P:F ratio after medication administration

  2. Improvement in oxygen saturation [Pre-medication, 30 minutes post medication, 4 hours post-medication]

    Change in oxyhemoglobin as noted on an arterial blood gas sample after medication administration

  3. Improvement in partial pressure of oxygen in the bloodstream [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Santa Barbara Cottage Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Santa Barbara Cottage Hospital
ClinicalTrials.gov Identifier:
NCT04946162
Other Study ID Numbers:
  • 20-63mrx
First Posted:
Jun 30, 2021
Last Update Posted:
Jul 2, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Pneumonia
Respiratory Distress Syndrome
Tadalafil

Study Results

No Results Posted as of Jul 2, 2021