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The Use of Tadalafil in Confirmed COVID-19 Pneumonia.

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ClinicalTrials.gov Identifier: NCT04946162
Recruitment Status : Withdrawn (The investigators never completed the IRB application due to decrease in need to conduct the study.)
First Posted : June 30, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Santa Barbara Cottage Hospital

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
COVID Sars-CoV2 ARDS, Human Drug: Tadalafil Pill Phase 4

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Study Type : Interventional  (Clinical Trial)
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Tadalafil in Confirmed COVID-19 Pneumonia.
Actual Study Start Date : April 20, 2020
Actual Primary Completion Date : April 20, 2020
Actual Study Completion Date : April 20, 2020


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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Additional Information:
Publications:

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Responsible Party: Santa Barbara Cottage Hospital
ClinicalTrials.gov Identifier: NCT04946162    
Other Study ID Numbers: 20-63mrx
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Pneumonia
Respiratory Distress Syndrome
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents