Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
Study NCT ID:
NCT04338828
Status:
TERMINATED
Last Update Posted:
2022-01-06
First Post:
2020-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nitric Oxide Inhalation Therapy for COVID-19 Infections in the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045462', 'term': 'Endothelium-Dependent Relaxing Factors'}], 'ancestors': [{'id': 'D014665', 'term': 'Vasodilator Agents'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'whyStopped': 'Absence of patients meeting criteria following initial COVID surge. DMSB recommended analysis of results to date and early closure.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-15', 'studyFirstSubmitDate': '2020-04-05', 'studyFirstSubmitQcDate': '2020-04-05', 'lastUpdatePostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of return visits to the ED', 'timeFrame': '28 days', 'description': 'Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to return to the ED with worsening symptoms'}], 'secondaryOutcomes': [{'measure': 'Inpatient hospitalizations required', 'timeFrame': '28 days', 'description': 'Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require hospitalization during their COVID-19 course'}, {'measure': 'Rates of intubation', 'timeFrame': '28 days', 'description': 'Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require intubation during their COVID-19 course'}, {'measure': 'Rates of mortality', 'timeFrame': '28 days', 'description': 'Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to die of any cause within 28 days of their initial ED visit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inhaled nitric oxide', 'emergency department', 'emergency medicine', 'respiratory infection'], 'conditions': ['COVID19']}, 'descriptionModule': {'briefSummary': 'The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains. The primary aim of this study is to determine whether inhaled NO improves short term respiratory status, prevents future hospitalization, and improves the clinical course in patients diagnosed with COVID-19 specifically in the emergency department.', 'detailedDescription': 'The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains.\n\nPreliminary data support a microbicidal effect of high concentration inhaled NO. We hypothesize that high concentration inhaled NO can have a viricidal effect against SARS-Cov-2 and prevent the deterioration to a severe form of COVID-19 when administered at an early stage of the disease. Additional potential mechanisms why INO may be effective in this indication: 1)improves V/Q ratio, 2) reduces PVR and PAP, 3) Anti-thrombotic in lung. This would have potential benefit for the patients in terms of reducing the severity of the clinical course and time to recovery. An additional benefit could be for the society since a faster and a less severe clinical course could protect limited hospital resources (ED, floor, and ICU) from being overwhelmed.\n\nThe primary aim is to prevent the deterioration of mild COVID-19 infection (defined by a RT-PCR positive for SARS-CoV-2 in a specimen from any site) with respiratory signs/ symptoms to a more severe form of the disease as defined by the patient needing to 1) return to the ED, 2) be admitting to the hospital, 3) be intubated, 4) and all cause 28 day mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Presentation to the ED with respiratory symptoms likely caused by COVID-19\n* Patient displays at least one of the following\n\n 1. respiratory rate ≥ 24\n 2. new cough\n 3. new atypical chest pain\n 4. new dyspnea\n 5. oxygen saturation \\< 97% at rest\n 6. chest x-ray with new changes consistent with COVID-related airspace disease\n* Cleared for discharge home by attending physician\n* Obtained COVID testing (results not required at time of enrollment)\n* Onset of symptoms ≤12 days prior to ED visit\n\nExclusion Criteria:\n\n* Attending physician estimation (\\< 50% likelihood) of other more likely non-COVID etiology\n* Presence of tracheostomy\n* Requirement of oxygen therapy to maintain resting oxygen saturation of \\> 94%\n* Clinical contraindication to use of inhaled nitric oxide'}, 'identificationModule': {'nctId': 'NCT04338828', 'acronym': 'NO COV-ED', 'briefTitle': 'Nitric Oxide Inhalation Therapy for COVID-19 Infections in the ED', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Nitric Oxide Inhalation Therapy for COVID-19 Infections in the Emergency Department', 'orgStudyIdInfo': {'id': '2019P00XXXX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Inhaled nitric oxide', 'interventionNames': ['Drug: Nitric Oxide Gas']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Inhaled supplemental oxygen', 'interventionNames': ['Other: Inhaled Supplemental Oxygen']}], 'interventions': [{'name': 'Nitric Oxide Gas', 'type': 'DRUG', 'description': 'Inhaled NO administered at target inspired concentration 140 - 300 ppm for 20-30 minutes', 'armGroupLabels': ['Treatment Group']}, {'name': 'Inhaled Supplemental Oxygen', 'type': 'OTHER', 'description': '2 L/min oxygen therapy', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Division Chief of Wilderness Medicine, Department of Emergency Medicine', 'investigatorFullName': 'N. Stuart Harris MD MFA', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}