COVID-19Phase 1/2NCT04601077
The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin
A Phase 1/2 study testing Nitric Oxide lozenges, 30 mg in people with COVID-19, run by Nitric Oxide Innovations LLC at 1 site in United States.
Trial summary
This study is a multi-center, randomized, double blinded, prospective, placebo controlled study. Patients upon diagnosis of COVID-19 (Corona Virus Disease-19) will be eligible to participate in the study. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Nitric Oxide lozenges, 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 524 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 30 Nov 2022
- Phase
- Phase 1/2
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of 50-85 years of age
- Subjects with recent COVID-19 diagnosis (within 72 hours), that are symptomatic (fever, cough, SOB, weakness, or other flu-like symptoms).
- Agrees to comply with study procedures (diary, oximeter readings, telephone follow up).
- Has given voluntary, written, informed consent to participate in the study.
- Identifies as African American or Hispanic Origin
- Patients must have at least 1 risk factor (history of hypertension (BP> 140/99) CHF, angina, prior MI, coronary angiography with one significantly occluded vessel, diabetes mellitus, obesity, or smoking, (for at least 5 years).
Who cannot join
- Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study.
- Patients unresponsive or unable to take anything by mouth (NPO).
- Individuals who are cognitively impaired and/or who are unable to give informed consent.
- Blood pressure below 110 mmHg systolic and 60 mmHg diastolic on entry into study.
- History of syncope or other symptoms of orthostatic hypotension.
- History of methemoglobinemia.
- Severe case of G6PD deficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
American Institute of Therapeutics
Lake Bluff, Illinois, 60044
About this study
Official title: Pilot Study: The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin
This study is a multi-center, randomized, double blinded, prospective, placebo controlled study. Patients upon diagnosis of COVID-19 (Corona Virus Disease-19) will be eligible to participate in the study. The purpose of this study is to find out the side effects and ability to take the study drug, Nitric Oxide (NO) lozenges when taken twice daily by mouth. If this study shows that the drug has no or few, acceptable side effects, it will then include up to 840 participants to find out if the drug can reduce bad outcomes of COVID-19 infection (hospitalization, ICU admission, death). In each part of the study, half of the subjects will receive the study drug and the other half will be given a placebo (inactive pill).
- Conditions
- COVID-19
- Being tested
- Nitric Oxide lozenges, 30 mg, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide lozenges, 30 mgDrug
Nitric Oxide lozenge, 30 mg twice a day for 30 days
PlaceboDrug
Placebo for Nitric Oxide lozenge, 30 mg twice a day for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide | Active comparator | Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days Receives: Drug: Nitric Oxide lozenges, 30 mg |
| Placebo | Placebo comparator | Placebo of Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low blood pressure
Blood pressure under 90 mmHg
Measured: 30 days
dizziness
Incidence of self reported dizziness
Measured: 30 days
Secondary outcomes (1)
Incidence of hospitalization, ICU admission, intubation, dialysis and death
The effects of NO therapy on incidence of hospitalization, intubation, ICU admission, dialysis and death in treated patients vs. those receiving placebo therapy.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Nov 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Why it stopped: The study stopped due to futility.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo Control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitric Oxide Innovations LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601077
- Sponsor's protocol ID
- IND150758 Pilot
- Status last verified
- Dec 2022
- First submitted
- 21 Oct 2020
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin
- ClinicalTrials.gov ID
- NCT04601077
- Acronym / sponsor ID
- IND150758 Pilot
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study stopped due to futility.
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Nitric Oxide Innovations LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 23 Oct 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 study is a multi-center, randomized, double blinded, prospective, placebo controlled study. Patients upon diagnosis of COVID-19 (Corona Virus Disease-19) will be eligible to participate in the study. The purpose of this study is to find out the side effects and ability to take the study drug, Nitric Oxide (NO) lozenges when taken twice daily by mouth. If this study shows that the drug has no or few, acceptable side effects, it will then include up to 840 participants to find out if the drug can reduce bad outcomes of COVID-19 infection (hospitalization, ICU admission, death). In each part of the study, half of the subjects will receive the study drug and the other half will be given a placebo (inactive pill).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Placebo Control
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide | Active comparator | Drug: Nitric Oxide lozenges, 30 mgNitric Oxide (NO) lozenges taken twice daily by mouth for 30 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo of Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female of 50-85 years of age
- Subjects with recent COVID-19 diagnosis (within 72 hours), that are symptomatic (fever, cough, SOB, weakness, or other flu-like symptoms).
- Agrees to comply with study procedures (diary, oximeter readings, telephone follow up).
- Has given voluntary, written, informed consent to participate in the study.
- Identifies as African American or Hispanic Origin
Key exclusion criteria (7 listed)
- Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study.
- Patients unresponsive or unable to take anything by mouth (NPO).
- Individuals who are cognitively impaired and/or who are unable to give informed consent.
- Blood pressure below 110 mmHg systolic and 60 mmHg diastolic on entry into study.
- History of syncope or other symptoms of orthostatic hypotension.
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 lozenges, 30 mgNitric Oxide lozenge, 30 mg twice a day for 30 days | Drug | Nitric Oxide |
| PlaceboPlacebo for Nitric Oxide lozenge, 30 mg twice a day for 30 days | Drug | Placebo |
Primary outcome
Low blood pressure
Time frame: 30 days
Blood pressure under 90 mmHg
dizziness
Time frame: 30 days
Incidence of self reported dizziness
1 secondary outcome
Incidence of hospitalization, ICU admission, intubation, dialysis and death
Time frame: 30 Days
Results and safety
The study was stopped early (reason given: The study stopped due to futility.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 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 1/2 study testing Nitric Oxide lozenges, 30 mg in people with COVID-19, run by Nitric Oxide Innovations LLC 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 7 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 Dec 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: The study stopped due to futility.). 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?
Low blood pressure (time frame: 30 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 6 Dec 2022.