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Efficacy of Inhaled Nitroglycerin in Moderate to Critically Ill COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04686760
Recruitment Status : Recruiting
First Posted : December 29, 2020
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Muhammad Mansoor Hafeez, University of Lahore

Study Description
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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

Condition or disease Intervention/treatment Phase
Corona Virus Infection Drug: Nitroglycerin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Inhaled Nitroglycerin in Moderate to Severe Cases of COVID-19 Patients
Actual Study Start Date : November 15, 2020
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nitroglycerin solution Drug: Nitroglycerin
2 mg/ml solution of nitroglycerin used for nebulization four hourly
No Intervention: standard solution


Outcome Measures
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Primary Outcome Measures :
  1. ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen [ Time Frame: 5-7 days ]
  2. Oxygen demand [ Time Frame: 5-7 days ]

Secondary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: 15 days ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686760


Contacts
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Contact: Muhammd Mansoor Hafeez, MBBS 0923214231613 mansoor.hafeez@imbb.uol.edu.pk
Contact: Muhammad Asim Rana, MBBS, MRCP 09234358070006 drasimrana@yahoo.com

Locations
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Pakistan
Bahria Town International Hospital Recruiting
Lahore, Punjab, Pakistan, 54000
Contact: Muhammad Asim Rana, MBBS, MRCP    0923435807006    drasimrana@yahoo.com   
Sponsors and Collaborators
University of Lahore
More Information
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Responsible Party: Muhammad Mansoor Hafeez, Doctor, University of Lahore
ClinicalTrials.gov Identifier: NCT04686760    
Other Study ID Numbers: IRBEC/BIH/08-2020
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Nitroglycerin
Vasodilator Agents