NCT05165992: Ventanyl

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

Status unknown Phase 3 Last updated 27 December 2021

What this trial tests

Phase 3 trial testing Nebulized Fentanyl in COVID-19 Pneumonia in 200 participants. Status unknown.

Timeline

1 February 2022

Primary endpoint
1 November 2022

1 December 2022

Quick facts

Lead sponsor	Hamad Medical Corporation
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	1 February 2022
Primary completion	1 November 2022
Estimated completion	1 December 2022

Drugs / interventions tested

• Nebulized Fentanyl — full drug profile →

Conditions studied

• COVID-19 Pneumonia — all drugs for COVID-19 Pneumonia →

Sponsor

Hamad Medical Corporation — full company profile →

Who can join

Adults 18 to 65, any sex, with COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Breathlessness
  Time frame: 15-minutes post-treatment
  The severity of breathlessness will be measured by the 10-point Borg Scale. Patients will be instructed to use this scale to rate the difficulty of breathing. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal.
• Throat Pain
  Time frame: 15-minutes post-treatment
  Throat pain will be graded by the Numerical Rating Scale (NRS), in which patients will be asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
• Cough
  Time frame: 15-minutes post-treatment
  The cough severity score represents a simple instrument, using a 10 point scale, where the patient can indicate the severity of their cough between the two extremes: one for no cough while 100 mm is the most severe cough.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nebulized fentanyl for respiratory symptoms in patients with COVID-19 (ventanyl trial).
   Shaikh N, Khatib MY, Wraidat MAA, Mohamed AS, et al · · 2022 · cited 2× · PMID 35089202 · DOI 10.1097/md.0000000000028637