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The investigators never completed the IRB application due to decrease in need to conduct the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tadalafil Group | Experimental | Each patient will be given tadalafil 40 mg one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil Pill | Drug | Each patient will be given tadalafil 40 mg one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in P:F ratio | 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 | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32381264 | Background | Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers D, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020 Jul;191:148-150. doi: 10.1016/j.thromres.2020.04.041. Epub 2020 Apr 30. | |
| 32299776 |
| Label | URL |
|---|---|
| Nu-Med Plus Closely Monitoring Outcomes on Two New Human Clinical Trials Using Inhaled Nitric Oxide in Treatment of COVID-19 | View source |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Participants will serve as a self-control, with values recorded pre-medication, 30 minutes after medication administration, and 4 hours after administration.
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| Magro C, Mulvey JJ, Berlin D, Nuovo G, Salvatore S, Harp J, Baxter-Stoltzfus A, Laurence J. Complement associated microvascular injury and thrombosis in the pathogenesis of severe COVID-19 infection: A report of five cases. Transl Res. 2020 Jun;220:1-13. doi: 10.1016/j.trsl.2020.04.007. Epub 2020 Apr 15. |
| 15234326 | Background | Keyaerts E, Vijgen L, Chen L, Maes P, Hedenstierna G, Van Ranst M. Inhibition of SARS-coronavirus infection in vitro by S-nitroso-N-acetylpenicillamine, a nitric oxide donor compound. Int J Infect Dis. 2004 Jul;8(4):223-6. doi: 10.1016/j.ijid.2004.04.012. |
| 15650225 | Background | Akerstrom S, Mousavi-Jazi M, Klingstrom J, Leijon M, Lundkvist A, Mirazimi A. Nitric oxide inhibits the replication cycle of severe acute respiratory syndrome coronavirus. J Virol. 2005 Feb;79(3):1966-9. doi: 10.1128/JVI.79.3.1966-1969.2005. |
| 19470885 | Background | 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. |
| A Pilot Study of Sildenafil in COVID-19 | View source |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |