Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
Study NCT ID:
NCT04443868
Status:
WITHDRAWN
Last Update Posted:
2021-07-16
First Post:
2020-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009569', 'term': 'Nitric Oxide'}], 'ancestors': [{'id': 'D026361', 'term': 'Reactive Nitrogen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No subjects enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2020-06-20', 'studyFirstSubmitQcDate': '2020-06-20', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity', 'timeFrame': '6 Days', 'description': 'Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms.'}], 'secondaryOutcomes': [{'measure': 'To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection', 'timeFrame': '2, 4 and 6 days', 'description': 'Measure the proportion of subjects reaching Ct threshold (ie: unmeasurable viral load) between NONI and control'}, {'measure': 'To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection', 'timeFrame': '2, 4 and 6 days', 'description': 'Measure the difference in time-to Ct threshold (ie: unmeasurable viral load) between NONI and control.'}, {'measure': 'To Measure the efficacy of NONI in prevention of progression of COVID-19', 'timeFrame': '28 days', 'description': 'Measure the proportion of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms'}, {'measure': 'To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19', 'timeFrame': '6 days', 'description': '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.'}, {'measure': 'To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19', 'timeFrame': '2, 4, 6, 14 and 28 days', 'description': 'Measure the difference in proportion of subjects experiencing a reduction of ≥ 5 from baseline between NONI and control arms.'}, {'measure': 'To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19', 'timeFrame': '2, 4, 6, 14 and 28 days', 'description': 'Measure the difference in proportion of subjects with reduction to a score of zero from baseline between NONI and control arms.'}, {'measure': 'To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection', 'timeFrame': '14 days', 'description': 'Number of participants lost-to-follow-up,discontinuing study treatment or number of treatments due to intolerance'}, {'measure': 'To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection', 'timeFrame': '14 days', 'description': 'Severity and frequency of adverse events, pain, discomfort or discontinuations of treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV Infection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\n* 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.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;\n* Men and Women ≥ 18years of age;\n* 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;\n* COVID-19 infection confirmed with a laboratory antigen or SARS-CoV-2 RT-PCR nasal swab;\n* Specimen collected within the past 48 hours;\n* 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;\n* 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);\n\n * Hormonal methods and the IUD must be in use at least 30 days prior to first Study drug administration\n * Abstinence and barrier methods must be in use at least 14 days prior to Study drug administration\n * Vasectomy must be completed 3 months prior to first Study drug administration; or in the alternative that a 0 sperm count will suffice.\n\nExclusion Criteria:\n\n* Current tracheostomy or laryngectomy;\n* 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;\n* Need for hospitalization for any reason;\n* Inability to safely self-administer nasal irrigation\n* Any clinical contraindications, as judged by the Qualified Medical Practitioner;\n* Clinical signs indicative of moderate, severe or critical COVID severity symptoms (as defined by FDA COVID-19 Guidance Document)\n* Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;\n* Lactating, pregnant or planning to become pregnant during the study period;\n* Diagnosed with prior COVID-19 infection (\\>48 hours from the time the test is reported prior to the time of screening).'}, 'identificationModule': {'nctId': 'NCT04443868', 'briefTitle': 'Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanotize Research and Development corp.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'COVID-IND-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitric Oxide Releasing Solution', 'description': 'Daily nasal irrigation (240mL) 14.4ppm', 'interventionNames': ['Drug: Nitric Oxide-Releasing Drug']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Isotonic Saline', 'description': 'Daily nasal irrigation (240mL) 0.9% saline', 'interventionNames': ['Drug: Nitric Oxide-Releasing Drug']}], 'interventions': [{'name': 'Nitric Oxide-Releasing Drug', 'type': 'DRUG', 'otherNames': ['nitric oxide'], 'description': 'Nasal Spray + Nasal Irrigation', 'armGroupLabels': ['Nitric Oxide Releasing Solution', 'Placebo Isotonic Saline']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mike armstrong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Richmond ENT'}, {'name': 'Chris Miller, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SaNOtize Scientific Advisor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanotize Research and Development corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}