Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19 (Ventanyl)
Primary Purpose
COVID-19 Pneumonia
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nebulized Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nebulized Fentanyl
Nebulized 0.9% Saline Solution
Arm 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
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
Outcomes
Primary Outcome Measures
Breathlessness
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05165992
First Posted
December 20, 2021
Last Updated
December 27, 2021
Sponsor
Hamad Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05165992
Brief Title
Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19
Acronym
Ventanyl
Official Title
Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19 (Ventanyl Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nebulized Fentanyl
Arm Type
Active Comparator
Arm 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
Arm Title
Nebulized 0.9% Saline Solution
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Nebulized Fentanyl
Intervention Description
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
Primary Outcome Measure Information:
Title
Breathlessness
Description
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.
Time Frame
15-minutes post-treatment
Title
Throat Pain
Description
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'.
Time Frame
15-minutes post-treatment
Title
Cough
Description
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.
Time Frame
15-minutes post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdulqadir J Nashwan
Phone
0097466473549
Email
ANashwan@hamad.qa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Y Khatib, MD
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33145156
Citation
Hildreth L, Pett D, Higgins E. Nebulized fentanyl for refractory dyspnea secondary to chronic obstructive pulmonary disease (COPD): A case report. Respir Med Case Rep. 2020 Oct 12;31:101251. doi: 10.1016/j.rmcr.2020.101251. eCollection 2020.
Results Reference
background
PubMed Identifier
14769753
Citation
Foral PA, Malesker MA, Huerta G, Hilleman DE. Nebulized opioids use in COPD. Chest. 2004 Feb;125(2):691-4. doi: 10.1378/chest.125.2.691.
Results Reference
background
PubMed Identifier
28687551
Citation
Afolabi TM, Nahata MC, Pai V. Nebulized opioids for the palliation of dyspnea in terminally ill patients. Am J Health Syst Pharm. 2017 Jul 15;74(14):1053-1061. doi: 10.2146/ajhp150893.
Results Reference
background
PubMed Identifier
25010531
Citation
Krajnik M, Jassem E, Sobanski P. Opioid receptor bronchial tree: current science. Curr Opin Support Palliat Care. 2014 Sep;8(3):191-9. doi: 10.1097/SPC.0000000000000072.
Results Reference
background
PubMed Identifier
24914770
Citation
Boyden JY, Connor SR, Otolorin L, Nathan SD, Fine PG, Davis MS, Muir JC. Nebulized medications for the treatment of dyspnea: a literature review. J Aerosol Med Pulm Drug Deliv. 2015 Feb;28(1):1-19. doi: 10.1089/jamp.2014.1136. Epub 2014 Jun 10.
Results Reference
background
PubMed Identifier
18443635
Citation
Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
Results Reference
background
PubMed Identifier
18046866
Citation
Uronis HE, Currow DC, Abernethy AP. Palliative management of refractory dyspnea in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(3):289-304. doi: 10.2147/copd.2006.1.3.289.
Results Reference
background
PubMed Identifier
34582457
Citation
Elliott J, Whitaker M, Bodinier B, Eales O, Riley S, Ward H, Cooke G, Darzi A, Chadeau-Hyam M, Elliott P. Predictive symptoms for COVID-19 in the community: REACT-1 study of over 1 million people. PLoS Med. 2021 Sep 28;18(9):e1003777. doi: 10.1371/journal.pmed.1003777. eCollection 2021 Sep.
Results Reference
background
PubMed Identifier
33170317
Citation
Scialo F, Daniele A, Amato F, Pastore L, Matera MG, Cazzola M, Castaldo G, Bianco A. ACE2: The Major Cell Entry Receptor for SARS-CoV-2. Lung. 2020 Dec;198(6):867-877. doi: 10.1007/s00408-020-00408-4. Epub 2020 Nov 10.
Results Reference
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Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19
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