SARS-CoV InfectionPhase 2NCT04443868
Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection
A Phase 2 study testing Nitric Oxide-Releasing Drug in people with SARS-CoV Infection, run by Sanotize Research and Development corp..
Trial summary
This is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- Nitric Oxide-Releasing Drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to 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
- Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
- Men and Women ≥ 18years of age;
- Internet access and capability and willingness to use to participate in audio or audio/video engagements with medical professionals, receive texts, emails, and phone calls from study staff and have a device and reasonable cellular data or other internet access to submit daily study required information using a smart phone, tablet, laptop, or desktop computer during the study period;
- COVID-19 infection confirmed with a laboratory antigen or SARS-CoV-2 RT-PCR nasal swab;
- Specimen collected within the past 48 hours;
- Mild COVID /FLU symptoms which may include no symptoms, fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath or dyspnea;
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- Must be willing to use one highly effective birth control method which include: abstinence, hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation or to use two forms of effective birth control methods which include: barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge);
- Hormonal methods and the IUD must be in use at least 30 days prior to first Study drug administration
- Abstinence and barrier methods must be in use at least 14 days prior to Study drug administration
- Vasectomy must be completed 3 months prior to first Study drug administration; or in the alternative that a 0 sperm count will suffice.
Who cannot join
- Current tracheostomy or laryngectomy;
- Concomitant respiratory therapy such as oxygen or ventilatory support. Positive airway pressure for obstructive sleep apnea is permitted if treatment was established with good compliance at least 3 months before enrolment;
- Need for hospitalization for any reason;
- Inability to safely self-administer nasal irrigation
- Any clinical contraindications, as judged by the Qualified Medical Practitioner;
- Clinical signs indicative of moderate, severe or critical COVID severity symptoms (as defined by FDA COVID-19 Guidance Document)
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- Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;
- Lactating, pregnant or planning to become pregnant during the study period;
- Diagnosed with prior COVID-19 infection (>48 hours from the time the test is reported prior to the time of screening).
About this study
Official title: Double-Blinded, Placebo-Controlled Parallel, Phase II Clinical Efficacy Study Evaluating NORS To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Mild COVID-19
This is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection.
Read the detailed description
Up to 50 subjects will be enrolled into one of two cohorts of this study in a ratio of 1:1 (Treatment: Placebo Control). Subjects will be screened and randomized into one of two parallel cohorts.
- Treatment (N = up to 25): Subjects will be enrolled and receive daily NONI treatment for 14 days with a follow-up visit on Day 28 post randomization.
- Placebo (N = up to 25): Subjects will be enrolled and receive a placebo for 14 days with a follow-up visit on Day 28 post randomization.
- Conditions
- SARS-CoV Infection
- Being tested
- Nitric Oxide-Releasing Drug
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide-Releasing DrugDrug
Also called nitric oxide
Nasal Spray + Nasal Irrigation
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide Releasing Solution | Experimental | Daily nasal irrigation (240mL) 14.4ppm Receives: Drug: Nitric Oxide-Releasing Drug |
| Placebo Isotonic Saline | Placebo comparator | Daily nasal irrigation (240mL) 0.9% saline Receives: Drug: Nitric Oxide-Releasing Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity
Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms.
Measured: 6 Days
Secondary outcomes (8)
To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection
Measure the proportion of subjects reaching Ct threshold (ie: unmeasurable viral load) between NONI and control
Measured: 2, 4 and 6 days
To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection
Measure the difference in time-to Ct threshold (ie: unmeasurable viral load) between NONI and control.
Measured: 2, 4 and 6 days
To Measure the efficacy of NONI in prevention of progression of COVID-19
Measure the proportion of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms
Measured: 28 days
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19
Measure the difference in 12-point COVID Symptom PROs score 0-3 (min 0 \& max 36) and a QoL score from 0-100 (lower is worse) from baseline between NONI and control arms.
Measured: 6 days
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19
Measure the difference in proportion of subjects experiencing a reduction of ≥ 5 from baseline between NONI and control arms.
Measured: 2, 4, 6, 14 and 28 days
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19
Measure the difference in proportion of subjects with reduction to a score of zero from baseline between NONI and control arms.
Measured: 2, 4, 6, 14 and 28 days
To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection
Number of participants lost-to-follow-up,discontinuing study treatment or number of treatments due to intolerance
Measured: 14 days
To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection
Severity and frequency of adverse events, pain, discomfort or discontinuations of treatment.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study startJan 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: No subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanotize Research and Development corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike armstrong, MD, Principal investigator, Richmond ENTChris Miller, Ph.D, Study director, SaNOtize Scientific Advisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443868
- Sponsor's protocol ID
- COVID-IND-02
- Status last verified
- Jul 2021
- First submitted
- 20 Jun 2020
- Last updated
- 16 Jul 2021
- 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 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blinded, Placebo-Controlled Parallel, Phase II Clinical Efficacy Study Evaluating NORS To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Mild COVID-19
- ClinicalTrials.gov ID
- NCT04443868
- Acronym / sponsor ID
- COVID-IND-02
- Conditions
- SARS-CoV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sanotize Research and Development corp.Industry (pharma, biotech, devices)
- Study start
- Jan 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 23 Jun 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 is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection.
Detailed description
Up to 50 subjects will be enrolled into one of two cohorts of this study in a ratio of 1:1 (Treatment: Placebo Control). Subjects will be screened and randomized into one of two parallel cohorts.
- Treatment (N = up to 25): Subjects will be enrolled and receive daily NONI treatment for 14 days with a follow-up visit on Day 28 post randomization.
- Placebo (N = up to 25): Subjects will be enrolled and receive a placebo for 14 days with a follow-up visit on Day 28 post randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide Releasing Solution | Experimental | Drug: Nitric Oxide-Releasing DrugDaily nasal irrigation (240mL) 14.4ppm |
| Placebo Isotonic Saline | Placebo comparator | Drug: Nitric Oxide-Releasing DrugDaily nasal irrigation (240mL) 0.9% saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
- Men and Women ≥ 18years of age;
- Internet access and capability and willingness to use to participate in audio or audio/video engagements with medical professionals, receive texts, emails, and phone calls from study staff and have a device and reasonable cellular data or other internet access to submit daily study required information using a smart phone, tablet, laptop, or desktop computer during the study period;
- COVID-19 infection confirmed with a laboratory antigen or SARS-CoV-2 RT-PCR nasal swab;
- Specimen collected within the past 48 hours;
Key exclusion criteria (9 listed)
- Current tracheostomy or laryngectomy;
- Concomitant respiratory therapy such as oxygen or ventilatory support. Positive airway pressure for obstructive sleep apnea is permitted if treatment was established with good compliance at least 3 months before enrolment;
- Need for hospitalization for any reason;
- Inability to safely self-administer nasal irrigation
- Any clinical contraindications, as judged by the Qualified Medical Practitioner;
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-Releasing DrugAlso: nitric oxideNasal Spray + Nasal Irrigation | Drug | Nitric Oxide Releasing Solution, Placebo Isotonic Saline |
Primary outcome
To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity
Time frame: 6 Days
Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms.
8 secondary outcomes
To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection
Time frame: 2, 4 and 6 days
To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection
Time frame: 2, 4 and 6 days
To Measure the efficacy of NONI in prevention of progression of COVID-19
Time frame: 28 days
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19
Time frame: 6 days
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19
Time frame: 2, 4, 6, 14 and 28 days
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19
Time frame: 2, 4, 6, 14 and 28 days
To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection
Time frame: 14 days
To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection
Time frame: 14 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 16 Jul 2021.
- 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.
Mike armstrong, MD principal investigator
Richmond ENT
Chris Miller, Ph.D study director
SaNOtize Scientific Advisor
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide-Releasing Drug in people with SARS-CoV Infection, run by Sanotize Research and Development corp..
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 10 inclusion and 9 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 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 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?
To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity (time frame: 6 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 16 Jul 2021.