Back to resultsEfficacy of Inhaled Nitroglycerin in Moderate to Critically Ill COVID-19 Patients
Primary Purpose
Corona Virus Infection
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Nitroglycerin
Sponsored by
About this trial
This is an interventional treatment trial for Corona Virus Infection
Eligibility Criteria
Inclusion Criteria:
Diagnosed admitted cases of Covid-19 degree of illness should be moderate to severe both male and female every age group
Exclusion Criteria:
allergic to nitroglycerin sudden drop in blood pressure not given consent
Sites / Locations
- Bahria Town International Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nitroglycerin solution
standard solution
Arm Description
Outcomes
Primary Outcome Measures
ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen
Oxygen demand
Secondary Outcome Measures
Duration of hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04686760
Brief Title
Efficacy of Inhaled Nitroglycerin in Moderate to Critically Ill COVID-19 Patients
Official Title
Efficacy of Inhaled Nitroglycerin in Moderate to Severe Cases of COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
March 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In current analysis moderate to severely ill Covid-19 infected patients will be nebulized with nitroglycerin, and they will be compared with the standard nebulization
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitroglycerin solution
Arm Type
Experimental
Arm Title
standard solution
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Intervention Description
2 mg/ml solution of nitroglycerin used for nebulization four hourly
Primary Outcome Measure Information:
Title
ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen
Time Frame
5-7 days
Title
Oxygen demand
Time Frame
5-7 days
Secondary Outcome Measure Information:
Title
Duration of hospital stay
Time Frame
15 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed admitted cases of Covid-19 degree of illness should be moderate to severe both male and female every age group
Exclusion Criteria:
allergic to nitroglycerin sudden drop in blood pressure not given consent
Facility Information:
Facility Name
Bahria Town International Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Inhaled Nitroglycerin in Moderate to Critically Ill COVID-19 Patients
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