CClinicalTrials.gg
Sign In
WithdrawnNCT04443868Updated Jul 16, 2021

Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection

A Phase 2 interventional study of Nitric Oxide-Releasing Drug in SARS-CoV Infection, sponsored by Sanotize Research and Development corp.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-16.

Sponsored by Sanotize Research and Development corp. · Phase 2, Interventional, and Treatment

Why this study was withdrawn
No subjects enrolled
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.
02

Conditions studied

  • SARS-CoV Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

Sanotize Research and Development corp. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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;

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Nitric Oxide Releasing Solution

    Daily nasal irrigation (240mL) 14.4ppm

    Drug: Nitric Oxide-Releasing Drug

  • Placebo comparator
    Placebo Isotonic Saline

    Daily nasal irrigation (240mL) 0.9% saline

    Drug: Nitric Oxide-Releasing Drug

Interventions

  • DrugNitric Oxide-Releasing Drug

    Nasal Spray + Nasal Irrigation

    Also known as: nitric oxide

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 Days

Secondary outcomes

  1. 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

    Time frame: 2, 4 and 6 days

  2. 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.

    Time frame: 2, 4 and 6 days

  3. 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

    Time frame: 28 days

  4. 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.

    Time frame: 6 days

  5. 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.

    Time frame: 2, 4, 6, 14 and 28 days

  6. 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.

    Time frame: 2, 4, 6, 14 and 28 days

  7. 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

    Time frame: 14 days

  8. 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.

    Time frame: 14 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04443868
Lead sponsor
Sanotize Research and Development corp.
Responsible party
Sponsor
First posted
Jun 23, 2020
Start date
Jan 2021 (estimated)
Primary completion
Apr 2021 (estimated)
Completion
Jul 2021 (estimated)
Last update
Jul 16, 2021

Study contacts

Mike armstrong, MD
principal investigator · Richmond ENT
Chris Miller, Ph.D
study director · SaNOtize Scientific Advisor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections→

Other studies from this sponsor

Sanotize Research and Development corp.

Start the discussion