Corona Virus InfectionNCT04686760
Efficacy of Inhaled Nitroglycerin in Moderate to Critically Ill COVID-19 Patients
A study testing Nitroglycerin in people with Corona Virus Infection, run by University of Lahore at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- Nitroglycerin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2020to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed admitted cases of Covid-19 degree of illness should be moderate to severe both male and female every age group
Who cannot join
- allergic to nitroglycerin sudden drop in blood pressure not given consent
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahria Town International Hospital
Lahore, Punjab Province, 54000
About this study
Official title: 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
- Conditions
- Corona Virus Infection
- Being tested
- Nitroglycerin
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroglycerinDrug
2 mg/ml solution of nitroglycerin used for nebulization four hourly
| Study group | Role | What they receive |
|---|---|---|
| Nitroglycerin solution | Experimental | Not described Receives: Drug: Nitroglycerin |
| standard solution | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen
Measured: 5-7 days
Oxygen demand
Measured: 5-7 days
Secondary outcomes (1)
Duration of hospital stay
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start15 Nov 2020
- Primary completion15 Dec 2021
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Mansoor Hafeez, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686760
- Sponsor's protocol ID
- IRBEC/BIH/08-2020
- Status last verified
- May 2022
- First submitted
- 24 Dec 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Inhaled Nitroglycerin in Moderate to Severe Cases of COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04686760
- Acronym / sponsor ID
- IRBEC/BIH/08-2020
- Conditions
- Corona Virus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitroglycerin solution | Experimental | Drug: Nitroglycerin |
| standard solution | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed admitted cases of Covid-19 degree of illness should be moderate to severe both male and female every age group
Key exclusion criteria (1 listed)
- allergic to nitroglycerin sudden drop in blood pressure not given consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitroglycerin2 mg/ml solution of nitroglycerin used for nebulization four hourly | Drug | Nitroglycerin solution |
Primary outcome
ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen
Time frame: 5-7 days
Oxygen demand
Time frame: 5-7 days
1 secondary outcome
Duration of hospital stay
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Corona Virus Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitroglycerin in people with Corona Virus Infection, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen (time frame: 5-7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.