COVID-19Phase 2NO-COVERNCT04398290
iNOPulse for COVID-19
A Phase 2 study testing Inhaled nitric oxide (iNO), Nitrogen gas and Oxygen gas in people with COVID-19 and Hypoxemia, run by Roger Alvarez at 1 site in United States.
Trial summary
This randomized, controlled trial will assess the efficacy and safety of pulsed iNO in subjects with COVID-19 who are hospitalized and require supplemental oxygen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Hypoxemia, Hypoxemic Respiratory Failure
- What is being tested?
- Inhaled nitric oxide (iNO), Nitrogen gas and Oxygen gas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 15 Jul 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 or above
- Proven COVID-19 viral infection. Non-confirmed highly suspicious suspects may be enrolled.
- Presence of radiographic findings compatible with pneumonia/pneumonitis.
- Patients requiring at least 3 L/m oxygen via nasal canula to maintain O2 above 92%.
- Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine).
- Willing and able to comply with treatment schedule and study procedures.
Who cannot join
- Patient with severe hypoxemia who are unable to maintain an oxygen saturation (SpO2) > 88% on a maximum supplemental oxygen of 6 L/m by nasal cannula and a non-rebreather facemask.
- Participating in any other clinical trial for COVID-19
- Pregnancy, or positive pregnancy test in a pre-dose examination.
- Open tracheostomy.
- Clinical contra-indication, as deemed by the PI or their designee.
- Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as intravenous lidocaine, or topical benzocaine or dapsone at screening.
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- Known history or clinical evidence of heart failure or left ventricular dysfunction (LVEF < 45%).
- Significant hemoptysis
- Unable to provide informed consent (proxy consent is acceptable if available)
- Any of the following conditions at time of possible enrollment: Fulminant Liver Failure, Acute Coronary Syndrome , Renal Failure requiring dialysis, Bacteremia, Shock, Cardiac arrest, Cardiac arrhythmia requiring acute treatment, Delirium / Encephalopathy, Severe Disseminated Intravascular Coagulation, Gastrointestinal hemorrhage, Hypoglycemia, Pneumothorax, Rhabdomyolysis / Myositis, Seizures, or Acute Stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Hospitals & Clinics
Miami, Florida, 33125
About this study
Official title: Randomized Controlled Trial Of A Delivered Continuously By Nasal Cannula For The Treatment Of Patients With COVID-19 And Mild To Moderate Hypoxemia Requiring Supplemental Oxygen
This randomized, controlled trial will assess the efficacy and safety of pulsed iNO in subjects with COVID-19 who are hospitalized and require supplemental oxygen.
- Conditions
- COVID-19, Hypoxemia, Hypoxemic Respiratory Failure
- Being tested
- Inhaled nitric oxide (iNO), Nitrogen gas, Oxygen gas
- Keywords
- hypoxemia, respiratory failure, COVID-19, inhaled nitric oxide
- Medical subject headings
- COVID-19, Hypoxia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled nitric oxide (iNO)Drug
iNO Pulse 250 mcg/kg ideal body weight (IBW)/hour
Nitrogen gasDrug
250 mcg/kg ideal body weight (IBW)/hour
Oxygen gasDrug
Supplemental oxygen administered via nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| iNOpulse Treatment Group | Experimental | Participants in this group will receive iNO delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days. Receives: Drug: Inhaled nitric oxide (iNO); Drug: Oxygen gas |
| Placebo Group | Active comparator | Participants in this group will receive nitrogen gas delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days Receives: Drug: Nitrogen gas; Drug: Oxygen gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
As assessed per treating physician's discretion.
Measured: Up to 14 days
Incidence of adverse events
Incidence of hypoxemia and hypotension as assessed per treating physician's discretion.
Measured: Up to 6 hours
Incidence of methemoglobinemia
Incidence of increase to > 5% total methemoglobin as assessed by pulse oximetry.
Measured: Up to 14 days
Secondary outcomes (4)
Number of participants with progression of respiratory failure
Worsening respiratory status as defined by any one of the following: Implementation of High Flow Nasal Cannula (HFNC), non-rebreather mask, non-invasive ventilation, intubation and mechanical ventilation or need for intubation (in the event the patient is not intubated due to do not intubate (DNI) or do not resuscitate (DNR) status).
Measured: Up to 14 days
Time until resolution of hypoxemia
The number of days until hypoxemia is resolved as per treating physician assessment
Measured: Up to 14 days
Incidence of mortality
Incidence of death during hospitalization and after discharge up to 28 days
Measured: Up to 28 days
Duration of hospitalization
Number of days of hospitalization
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Why it stopped: IRB AND FDA REVIEWS DEFERRED
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roger Alvarez
- Sponsor type
- University, hospital or other
- Collaborators
- Bellerophon Therapeutics
- Responsible party
- Sponsor-investigator, Roger Alvarez, University of Miami
- Investigators
- Roger A Alvarez, D.O., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398290
- Sponsor's protocol ID
- 20200449
- Acronym
- NO-COVER
- Status last verified
- Aug 2020
- First submitted
- 20 May 2020
- Last updated
- 19 Aug 2020
- 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 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Of A Delivered Continuously By Nasal Cannula For The Treatment Of Patients With COVID-19 And Mild To Moderate Hypoxemia Requiring Supplemental Oxygen
- ClinicalTrials.gov ID
- NCT04398290
- Acronym / sponsor ID
- NO-COVER / 20200449
- Conditions
- COVID-19, Hypoxemia, Hypoxemic Respiratory Failure
- Keywords
- hypoxemia, respiratory failure, COVID-19, inhaled nitric oxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB AND FDA REVIEWS DEFERRED
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roger AlvarezUniversity, hospital or other
- Collaborators
- Bellerophon Therapeutics
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 21 May 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.
This randomized, controlled trial will assess the efficacy and safety of pulsed iNO in subjects with COVID-19 who are hospitalized and require supplemental oxygen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iNOpulse Treatment Group | Experimental | Drug: Inhaled nitric oxide (iNO), Drug: Oxygen gasParticipants in this group will receive iNO delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days. |
| Placebo Group | Active comparator | Drug: Nitrogen gas, Drug: Oxygen gasParticipants in this group will receive nitrogen gas delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or above
- Proven COVID-19 viral infection. Non-confirmed highly suspicious suspects may be enrolled.
- Presence of radiographic findings compatible with pneumonia/pneumonitis.
- Patients requiring at least 3 L/m oxygen via nasal canula to maintain O2 above 92%.
- Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine).
Key exclusion criteria (10 listed)
- Patient with severe hypoxemia who are unable to maintain an oxygen saturation (SpO2) > 88% on a maximum supplemental oxygen of 6 L/m by nasal cannula and a non-rebreather facemask.
- Participating in any other clinical trial for COVID-19
- Pregnancy, or positive pregnancy test in a pre-dose examination.
- Open tracheostomy.
- Clinical contra-indication, as deemed by the PI or their designee.
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 |
|---|---|---|
| Inhaled nitric oxide (iNO)iNO Pulse 250 mcg/kg ideal body weight (IBW)/hour | Drug | iNOpulse Treatment Group |
| Nitrogen gas250 mcg/kg ideal body weight (IBW)/hour | Drug | Placebo Group |
| Oxygen gasSupplemental oxygen administered via nasal cannula | Drug | Placebo Group, iNOpulse Treatment Group |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: Up to 14 days
As assessed per treating physician's discretion.
Incidence of adverse events
Time frame: Up to 6 hours
Incidence of hypoxemia and hypotension as assessed per treating physician's discretion.
Incidence of methemoglobinemia
Time frame: Up to 14 days
Incidence of increase to > 5% total methemoglobin as assessed by pulse oximetry.
4 secondary outcomes
Number of participants with progression of respiratory failure
Time frame: Up to 14 days
Time until resolution of hypoxemia
Time frame: Up to 14 days
Incidence of mortality
Time frame: Up to 28 days
Duration of hospitalization
Time frame: Up to 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- 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.
Roger A Alvarez, D.O. principal investigator
University of Miami
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 Inhaled nitric oxide (iNO), Nitrogen gas and Oxygen gas in people with COVID-19 and Hypoxemia, run by Roger Alvarez 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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 19 Aug 2020. 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. 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 withdrawn before enrolling participants, so there are no results.
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?
Incidence of treatment emergent adverse events (time frame: Up to 14 days). The study lists 3 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 19 Aug 2020.