Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-09 @ 11:42 PM
Study NCT ID:
NCT04463420
Status:
UNKNOWN
Last Update Posted:
2020-11-04
First Post:
2020-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2020-07-04', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': 'up to 14 days', 'description': 'shortness of breath measured by Visual analog scale (VAS) dyspnea score. The minimum score is zero means shortness of breath and the highest score is 10 means the maximum intensity of shortness of breath.'}], 'secondaryOutcomes': [{'measure': 'long of hospitalization', 'timeFrame': 'up to 28 days', 'description': 'The length of time the patient is hospitalized after the diagnosis of COVID-19'}, {'measure': 'Radiological Treatment Response', 'timeFrame': 'up to 14 days', 'description': 'CT scans help determine how much the lungs are affected by COVID-19.'}, {'measure': 'Mortality', 'timeFrame': 'Up to 28 days', 'description': 'In-hospital mortality'}, {'measure': 'Allergic drug', 'timeFrame': 'up to 14 days', 'description': 'There will be known allergic reactions to the drugs.'}, {'measure': 'Laboratory Treatment Response', 'timeFrame': 'up to 14 days', 'description': 'Normal blood cell count and CRP count (normal laboratory range)'}, {'measure': 'O2 saturation without supplemental oxygen', 'timeFrame': 'up to 14 days', 'description': 'Using an oximeter pulse, the amount of oxygen saturation is measured. If the patient is receiving oxygen, first cut off the oxygen for 5 minutes and then measure. If the oxygen drops below 90 degrees, oxygen therapy will be re-established immediately.'}, {'measure': 'drug reactions Adverse', 'timeFrame': 'Up to 14 days', 'description': 'Complications in both groups should be evaluated and evaluated during treatment.\n\nprotective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions that measured by Physical examination.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study is a multi-center randomized, controlled, and blinded clinical trial study that will be performed in four medical-educational centers. In this study, the samples will be selected from among patients with SARS-CoV-2 as easy access and based on entry criteria and will be randomly divided into two groups, including a control group and an intervention group. The study will be conducted in four medical centers. From each center, 56 definitive Corona patients will be selected, who will be randomly divided into two groups of 28, for a total of 224 patients will enter the study. In the intervention group, in addition to receiving the test spray, Patients will also receive standard treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Conscious consent to participate in the study\n* Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR.\n* Strong clinical suspicion of covid 19 with positive findings in CT Scan\n* Shortness of breath\n\nExclusion Criteria:\n\n* Patients with HIV\n* Patients with cancer undergoing chemotherapy\n* Patients receiving Immune Mediators\n* Patients need hospitalization in the intensive care unit\n* Patients with uncontrolled heart, kidney or liver failure\n* Pregnant or lactating women\n* Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems)'}, 'identificationModule': {'nctId': 'NCT04463420', 'briefTitle': 'Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Baqiyatallah Medical Sciences University'}, 'officialTitle': 'Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19 a Multi-center Randomized Blinding Clinical Trial Study', 'orgStudyIdInfo': {'id': 'IR.BMSU.REC.1399.176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group', 'description': 'Intervention group: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days.', 'interventionNames': ['Drug: PHR160 Spray', 'Drug: Standard treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Control group: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days', 'interventionNames': ['Drug: Placebo', 'Drug: Standard treatment']}], 'interventions': [{'name': 'PHR160 Spray', 'type': 'DRUG', 'description': 'One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.', 'armGroupLabels': ['Test Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'participants will receive a placebo spray every hour. This process will continue for 10 days.', 'armGroupLabels': ['Control Group']}, {'name': 'Standard treatment', 'type': 'DRUG', 'description': ': Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days', 'armGroupLabels': ['Control Group', 'Test Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0', 'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Mohammad Sadegh Bagheri Baghdasht', 'role': 'CONTACT', 'email': 'sadegh.bagheri@gmail.com', 'phone': '+989356318204'}], 'facility': 'Mohammad Sadegh Bagheri Baghdasht', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Mohammad Sadegh Bagheri Baghdasht', 'role': 'CONTACT', 'email': 'sadegh.bagheri@gmail.com', 'phone': '0098 9356318204'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baqiyatallah Medical Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohammad Sadegh Bagheri Baghdasht', 'investigatorAffiliation': 'Baqiyatallah Medical Sciences University'}}}}