COVID19Phase 2NO COV-EDNCT04338828
Nitric Oxide Inhalation Therapy for COVID-19 Infections in the ED
A Phase 2 study testing Nitric Oxide Gas and Inhaled Supplemental Oxygen in people with COVID19, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19
- What is being tested?
- Nitric Oxide Gas and Inhaled Supplemental Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2020to 1 Mar 2021
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Presentation to the ED with respiratory symptoms likely caused by COVID-19
- Patient displays at least one of the following
- respiratory rate ≥ 24
- new cough
- new atypical chest pain
Show all 12Show fewer
- new dyspnea
- oxygen saturation < 97% at rest
- chest x-ray with new changes consistent with COVID-related airspace disease
- Cleared for discharge home by attending physician
- Obtained COVID testing (results not required at time of enrollment)
- Onset of symptoms ≤12 days prior to ED visit
Who cannot join
- Attending physician estimation (< 50% likelihood) of other more likely non-COVID etiology
- Presence of tracheostomy
- Requirement of oxygen therapy to maintain resting oxygen saturation of > 94%
- Clinical contraindication to use of inhaled nitric oxide
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Nitric Oxide Inhalation Therapy for COVID-19 Infections in the Emergency Department
The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains. The primary aim of this study is to determine whether inhaled NO improves short term respiratory status, prevents future hospitalization, and improves the clinical course in patients diagnosed with COVID-19 specifically in the emergency department.
Read the detailed description
The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains.
Preliminary data support a microbicidal effect of high concentration inhaled NO. We hypothesize that high concentration inhaled NO can have a viricidal effect against SARS-Cov-2 and prevent the deterioration to a severe form of COVID-19 when administered at an early stage of the disease. Additional potential mechanisms why INO may be effective in this indication: 1)improves V/Q ratio, 2) reduces PVR and PAP, 3) Anti-thrombotic in lung. This would have potential benefit for the patients in terms of reducing the severity of the clinical course and time to recovery. An additional benefit could be for the society since a faster and a less severe clinical course could protect limited hospital resources (ED, floor, and ICU) from being overwhelmed.
The primary aim is to prevent the deterioration of mild COVID-19 infection (defined by a RT-PCR positive for SARS-CoV-2 in a specimen from any site) with respiratory signs/ symptoms to a more severe form of the disease as defined by the patient needing to 1) return to the ED, 2) be admitting to the hospital, 3) be intubated, 4) and all cause 28 day mortality.
- Conditions
- COVID19
- Being tested
- Nitric Oxide Gas, Inhaled Supplemental Oxygen
- Keywords
- inhaled nitric oxide, emergency department, emergency medicine, respiratory infection
- Medical subject headings
- COVID-19, Emergencies, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide GasDrug
Inhaled NO administered at target inspired concentration 140 - 300 ppm for 20-30 minutes
Inhaled Supplemental OxygenOther
2 L/min oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Inhaled nitric oxide Receives: Drug: Nitric Oxide Gas |
| Control Group | Placebo comparator | Inhaled supplemental oxygen Receives: Other: Inhaled Supplemental Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of return visits to the ED
Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to return to the ED with worsening symptoms
Measured: 28 days
Secondary outcomes (3)
Inpatient hospitalizations required
Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require hospitalization during their COVID-19 course
Measured: 28 days
Rates of intubation
Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require intubation during their COVID-19 course
Measured: 28 days
Rates of mortality
Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to die of any cause within 28 days of their initial ED visit
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start18 Apr 2020
- Primary completion14 Jan 2021
- Study completion1 Mar 2021
Why it stopped: Absence of patients meeting criteria following initial COVID surge. DMSB recommended analysis of results to date and early closure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, N. Stuart Harris MD MFA, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338828
- Sponsor's protocol ID
- 2019P00XXXX
- Acronym
- NO COV-ED
- Status last verified
- Dec 2021
- First submitted
- 5 Apr 2020
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitric Oxide Inhalation Therapy for COVID-19 Infections in the Emergency Department
- ClinicalTrials.gov ID
- NCT04338828
- Acronym / sponsor ID
- NO COV-ED / 2019P00XXXX
- Conditions
- COVID19
- Keywords
- inhaled nitric oxide, emergency department, emergency medicine, respiratory infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Absence of patients meeting criteria following initial COVID surge. DMSB recommended analysis of results to date and early closure.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 18 Apr 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 8 Apr 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.
The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains. The primary aim of this study is to determine whether inhaled NO improves short term respiratory status, prevents future hospitalization, and improves the clinical course in patients diagnosed with COVID-19 specifically in the emergency department.
Detailed description
The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains.
Preliminary data support a microbicidal effect of high concentration inhaled NO. We hypothesize that high concentration inhaled NO can have a viricidal effect against SARS-Cov-2 and prevent the deterioration to a severe form of COVID-19 when administered at an early stage of the disease. Additional potential mechanisms why INO may be effective in this indication: 1)improves V/Q ratio, 2) reduces PVR and PAP, 3) Anti-thrombotic in lung. This would have potential benefit for the patients in terms of reducing the severity of the clinical course and time to recovery. An additional benefit could be for the society since a faster and a less severe clinical course could protect limited hospital resources (ED, floor, and ICU) from being overwhelmed.
The primary aim is to prevent the deterioration of mild COVID-19 infection (defined by a RT-PCR positive for SARS-CoV-2 in a specimen from any site) with respiratory signs/ symptoms to a more severe form of the disease as defined by the patient needing to 1) return to the ED, 2) be admitting to the hospital, 3) be intubated, 4) and all cause 28 day mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Nitric Oxide GasInhaled nitric oxide |
| Control Group | Placebo comparator | Other: Inhaled Supplemental OxygenInhaled supplemental oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years old
- Presentation to the ED with respiratory symptoms likely caused by COVID-19
- Patient displays at least one of the following
- Cleared for discharge home by attending physician
- Obtained COVID testing (results not required at time of enrollment)
Key exclusion criteria (4 listed)
- Attending physician estimation (< 50% likelihood) of other more likely non-COVID etiology
- Presence of tracheostomy
- Requirement of oxygen therapy to maintain resting oxygen saturation of > 94%
- Clinical contraindication to use of inhaled nitric oxide
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 |
|---|---|---|
| Nitric Oxide GasInhaled NO administered at target inspired concentration 140 - 300 ppm for 20-30 minutes | Drug | Treatment Group |
| Inhaled Supplemental Oxygen2 L/min oxygen therapy | Other | Control Group |
Primary outcome
Rates of return visits to the ED
Time frame: 28 days
Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to return to the ED with worsening symptoms
3 secondary outcomes
Inpatient hospitalizations required
Time frame: 28 days
Rates of intubation
Time frame: 28 days
Rates of mortality
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Absence of patients meeting criteria following initial COVID surge. DMSB recommended analysis of results to date and early closure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing Nitric Oxide Gas and Inhaled Supplemental Oxygen in people with COVID19, run by Massachusetts General Hospital at 1 site in United States.
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 12 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 Jan 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Absence of patients meeting criteria following initial COVID surge. DMSB recommended analysis of results to date and early closure.). Results are not available in the source record.
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?
Rates of return visits to the ED (time frame: 28 days). 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 6 Jan 2022.