Clinical trial NCT04946162: The Use of Tadalafil in Confirmed COVID-19 Pneumonia.
Official title: The Use of Tadalafil in Confirmed COVID-19 Pneumonia.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: COVID
Sars-CoV2
ARDS, Human
Lead sponsor: Santa Barbara Cottage Hospital
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Improvement in P:F ratio
timeFrame: Pre-medication, 30 minutes post medication, 4 hours post-medication
measure: Improvement in oxygen saturation
timeFrame: Pre-medication, 30 minutes post medication, 4 hours post-medication
measure: Improvement in partial pressure of oxygen in the bloodstream
timeFrame: Pre-medication, 30 minutes post medication, 4 hours post-medication
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Galie N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009 Jun 9;119(22):2894-903. doi: 10.1161/CIRCULATIONAHA.108.839274. Epub 2009 May 26.