Rapamune Improves Outcomes of Severe H1N1 Pneumonia

Status Completed

Clinical Trial Summary

Severe H1N1 pneumonia with acute respiratory failure shows hyperactive immune cells infiltration of lung. Rapamune, a mTOR inhibitor, modulates the immune response by blocking activation of T- and B-cells. To investigate the clinical efficiency of rapamune in severe H1N1 pneumonia with respiratory failure, this study was conducted.

Clinical Trial Description

From 2009 winter to 2011 spring, patients with flu-like symptoms in Chang Gung Memorial Hospital were screened by rapid antigen test and influenza subtype was confirmed by polymerization chain reaction (PCR). 38 H1N1 patients with severe hypoxemia [alveolar-arterial oxygen gradient, (A-a) O2 gradient, > 200 mmHg] requiring ventilator support were randomized to receive Rapamune (2mg/day) or not. Patients were then randomized to receive either Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days. The outcome variables include liberation of ventilator, ICU mortality, necessity of ECMO, Sequential Organ Failure Assessment (SOFA) score and complications after admission to ICU were recorded. SOFA score composed of scores from six organ systems, graded from 0 to 4 according to the degree of dysfunction/failure. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01620307
Study type	Interventional
Source	Chang Gung Memorial Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	June 2009
Completion date	December 2011

View Details

See also
Status	Clinical Trial	Phase
Suspended	`NCT03628560` - Alternate Methodology of Pulse Oximeter Validation	N/A
Completed	`NCT02866578` - Open Lung Protective Ventilation in Cardiac Surgery	N/A
Recruiting	`NCT06139081` - Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients With Painless Gastroscopy	N/A
Not yet recruiting	`NCT05964309` - Pre-oxygenation in Sitting Position and Oxygen Reserve Index	N/A
Completed	`NCT00675415` - Does Capnography Prevent Hypoxemia During Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound?	N/A
Completed	`NCT00740220` - Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation	N/A
Completed	`NCT04557605` - Effects of a Face Mask on Oxygenation During Exercise	N/A
Active, not recruiting	`NCT05479929` - Work of Breathing Assessment in Triage Scale
Recruiting	`NCT05422430` - Rebreathing-induced Hypoxia and Glucose Levels	N/A
Recruiting	`NCT03009643` - Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery	N/A
Completed	`NCT01949012` - Capnography Monitoring During Intravenous Conscious Sedation Sedation With Midazolam for Oral Surgery	N/A
Completed	`NCT01477450` - Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects	N/A
Completed	`NCT01470170` - Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy	Phase 4
Recruiting	`NCT06085859` - Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment	N/A
Recruiting	`NCT03969615` - SuperNO2VA™ and General Anesthesia Postoperative Care	N/A
Completed	`NCT02554110` - Peripheral Nerve Stimulation to Reduce Hypoxic Events	N/A
Completed	`NCT04566419` - poStoperative Anesthesia Care: Facial Mask vs Hfnc and Thoracic Ultrasound for Reduction of Atelectasis Incidence	N/A
Completed	`NCT04998253` - Effects in Oxygenation and Hypoxic Pulmonary Vasoconstriction in ARDS Secondary to SARS-CoV2	Early Phase 1
Recruiting	`NCT04079465` - Automated Oxygen Control by O2matic to Patients Admitted With Acute Hypoxemia	N/A
Recruiting	`NCT06022523` - Accuracy of Pulse Oximeters With Profound Hypoxia	N/A