Efficacy of Inhaled Nitroglycerin in Moderate to Critical... | NCT04686760

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

NCT04686760

Sponsor

University of Lahore

Status

Completed

Last Update Posted

May 18, 2022Actual

Enrollment

278Actual

Phase

Not Applicable

Conditions

Corona Virus Infection

Interventions

Nitroglycerin

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2020Actual

Primary Completion Date

Dec 15, 2021Actual

Completion Date

Mar 15, 2022Actual

First Submitted Date

Dec 24, 2020

First Submission Date that Met QC Criteria

Dec 25, 2020

First Posted Date

Dec 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2022

Last Update Posted Date

May 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

278Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nitroglycerin solution	Experimental		Drug: Nitroglycerin
standard solution	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nitroglycerin	Drug	2 mg/ml solution of nitroglycerin used for nebulization four hourly	Nitroglycerin solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen		5-7 days
Oxygen demand		5-7 days

Secondary Outcomes

Measure	Description	Time Frame
Duration of hospital stay		15 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bahria Town International Hospital		Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005996	Nitroglycerin

Ancestor Terms

ID	Term
D009574	Nitro Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided