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

Hamad Medical Corporation (HMC)

Status and phase: Unknown; Phase 3

Conditions: COVID-19 Pneumonia

Treatments: Drug: Nebulized Fentanyl

Study type: Interventional

Funder types: Industry

Identifiers

NCT05165992

MRC-01-21-798

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 - 65 years
• Confirmed diagnosis (COVID-19) - positive PCR
• Tachypnoea (Respiratory rate> 30/min)
• Ability to provide informed consent and perform all study procedures

Exclusion criteria

• History of allergy or adverse reaction to fentanyl or other opioids
• Pregnancy
• Active neuromuscular or musculoskeletal disease.
• Active malignancy
• Morbid obesity (Body mass index >40)
• Use of opioids in the previous 4 weeks.
• Inability to provide informed consent and perform all study procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups, including a placebo group

Nebulized Fentanyl

Active Comparator group

Description:

Intervention group (n=100): 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

Treatment:

Drug: Nebulized Fentanyl

Nebulized 0.9% Saline Solution

Placebo Comparator group

Description:

Control group (n=100): Administration of nebulized 0.9% saline solution (5 ml of normal saline), over 15 minutes, thrice daily using a traditional nebulizer. Treatment duration - 48 hours

Treatment:

Drug: Nebulized Fentanyl