NCT05165992

Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19

Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19 (Ventanyl Trial)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Patients with Coronavirus Disease (COVID-19) experience distressing and challenging to manage respiratory symptoms. Interventions such as Oxygen (O2) therapy, oral opiates, and traditional nebulizers like ipratropium bromide and salbutamol, are variably effective, and therapeutic responses in individual patients are difficult to predict. The purpose of this study is to investigate the efficacy of nebulized fentanyl citrate on dyspnea, cough, and throat pain in patients with COVID-19, as well as evaluate the safety with any potential adverse events. In COVID-19, about 59% of patients will exhibit cough, 35% generalized body ache and sore throat and 31% will have dyspnea. Nebulized Lidocaine, magnesium, and opioids are alternative methods for the management of respiratory symptoms in various patients. Fentanyl nebulization was found to be effective in decreasing dyspnea in chronic obstructive pulmonary disease (COPD) patients by decreasing the rate of spontaneous respiratory rate, modulating cortical activity, and diminishing the brain stem chemoreceptor response to hypoxia and hypercarbia. The investigators hypothesize that nebulized fentanyl is superior to nebulized saline in suppressing cough, respiratory drive, improving breathlessness or dyspnea with the additional advantage of throat pain relief with minimal adverse effects in patients with COVID-19.

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
DRUG	Nebulized Fentanyl	Administration of nebulized Fentanyl (25 μg in 5 ml of normal saline) over 15 mins, thrice daily using a traditional nebulizer. Treatment duration - 48 hours

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-11-01
• Completion: 2022-12-01
• First posted: 2021-12-21
• Last updated: 2022-01-13

Regulatory

• FDA-regulated drug study