- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04686760
Efficacy of Inhaled Nitroglycerin in Moderate to Critically Ill COVID-19 Patients
May 16, 2022 updated by: Muhammad Mansoor Hafeez, University of Lahore
Efficacy of Inhaled Nitroglycerin in Moderate to Severe Cases of COVID-19 Patients
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
278
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Bahria Town International Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nitroglycerin solution
|
2 mg/ml solution of nitroglycerin used for nebulization four hourly
|
|
No Intervention: standard solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen
Time Frame: 5-7 days
|
5-7 days
|
|
Oxygen demand
Time Frame: 5-7 days
|
5-7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duration of hospital stay
Time Frame: 15 days
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2020
Primary Completion (Actual)
December 15, 2021
Study Completion (Actual)
March 15, 2022
Study Registration Dates
First Submitted
December 24, 2020
First Submitted That Met QC Criteria
December 25, 2020
First Posted (Actual)
December 29, 2020
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBEC/BIH/08-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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