Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05449405
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2022-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-I
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002744', 'term': 'Chlorpheniramine'}, {'id': 'D059085', 'term': 'Nasal Sprays'}], 'ancestors': [{'id': 'D010632', 'term': 'Pheniramine'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000336', 'term': 'Aerosols'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a multi-center, Phase 2/3 Study to evaluate the efficacy and safety of nasally administered CPM in subjects with symptomatic COVID-19 with a positive PCR test.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2022-07-06', 'studyFirstSubmitQcDate': '2022-07-06', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily symptoms score (DSS)', 'timeFrame': 'Baseline through day 7', 'description': 'Change from baseline daily symptoms score (DSS) to day 7\n\nThe DSS is an instrument comprised of a four-point severity rating scale ranging from 0 to 3.\n\n0 = no symptoms\n\n1. = mild symptoms\n2. = moderate symptoms\n3. = severe symptoms.'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Baseline through day 7', 'description': 'Change from baseline visual analog scale (VAS) to day 7\n\nThe VAS is a quantitative method that evaluates the severity of symptoms on a scale of 1-10 (no signs to worst symptoms). A 10 cm line is used to grade the severity of symptoms from "no symptoms" (0 cm) to "the highest level of symptoms" (10 cm).'}], 'secondaryOutcomes': [{'measure': 'Hospitalization', 'timeFrame': 'Baseline through Day 28', 'description': 'The proportion of Hospitalizations'}, {'measure': 'Mortality', 'timeFrame': 'Baseline through Day 28', 'description': 'Rate of mortality'}, {'measure': 'The proportion of subjects reporting olfactory function', 'timeFrame': 'Baseline through Day 7', 'description': 'Olfactory function reported on a four-point severity rating scale ranging from 0 to 3.\n\n0-normal\n\n1. slightly damaged\n2. moderately damaged\n3. away'}, {'measure': 'The proportion of subjects reporting the presence of upper respiratory symptoms', 'timeFrame': 'Baseline through Day 7', 'description': 'The proportion of subjects reporting the presence of upper respiratory symptoms (anosmia, ageusia, cough, and nasal congestion) using a yes or no scale.\n\nYes- Present No- No symptoms present'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['COVID-19', 'Symptoms and Signs', 'COVID-19 Pandemic', 'Coronavirus Disease 2019', 'Coronavirus Infections']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to examine the effectiveness of intranasal-administered Chlorpheniramine Maleate in COVID-19-positive participants as part of early treatment for COVID-19. The main questions it aims to answer are:\n\n* To assess the efficacy of nasal spray with Chlorpheniramine (1.0%) for improving clinical recovery in COVID-19 patients.\n* To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine (1%) as an adjunct to the standard of care in reducing hospitalizations and improving clinical recovery in adult patients with mild COVID-19.', 'detailedDescription': 'The main goal of the present study is to examine the effectiveness of CPM intranasal spray as part of early treatment for COVID-19. The study will test the hypothesis that intranasal CPM would accelerate clinical recovery, particularly the alleviation of sensory symptoms and URS, in patients with COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients between 18 and 65 years (both inclusive)\n* Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected or proof of positive test ≤3 days before randomization)\n* Patients with mild COVID-19 have the following symptoms and signs prior to randomization (≤ 3days)\n* Upper respiratory tract symptoms (\\&/or fever) without shortness of breath or hypoxia. (SpO2 \\> 94 %)\n* Willingness to sign written informed consent document\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* Hospitalized patients\n* Subject with known allergy or hypersensitivity to the components of the formulation.\n* Patients receiving therapy with Monoamine oxidase inhibitors (MAOIs): rasagline, selegiline, isocarbonboxasid, phenelzine, tranylcypromine.\n* Patients with narrow-angle glaucoma\n* urinary retention\n* Sleep Apnea\n* History of immunodeficiency or receiving immunosuppressive therapy.\n* Patients with acute exacerbation of severe comorbidities such as chronic obstructive pulmonary disease (COPD), class 3 and 4 heart failure diagnosed according to the criteria of the New York Heart Failure Association (NYHA), or diseases with severe oxygenation problems\n* Any Surgical procedure in the past 12 weeks\n* Unable to make informed consent or refuse or renounce adherence to standard treatment protocols.\n* Any significant illness or drugs that could interfere with study parameters\n* Any other condition based on the investigator's clinical judgment does not justify the patient's participation in the study.\n* Participation in another clinical trial within the past 30 days\n* Clinically significant arrhythmia or symptomatic cardiac conditions including but not limited to QT elongation\n* QT interval less than 300 ms or more than 500 ms for both men and women."}, 'identificationModule': {'nctId': 'NCT05449405', 'acronym': 'ACCROS-I', 'briefTitle': 'Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-I', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Ferrer BioPharma'}, 'officialTitle': 'A Multicentric, Randomized, Double-Blind, Comparative, Prospective, Placebo-controlled, Phase-II/III Clinical Trial (ACCROS-I)', 'orgStudyIdInfo': {'id': 'DFB-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorpheniramine Malate (1%) Nasal Spray', 'description': 'Chlorpheniramine Malate (1%) Nasal Spray', 'interventionNames': ['Combination Product: Chlorpheniramine Maleate 1% Nasal Spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Nasal Spray', 'description': 'Placebo Nasal Spray', 'interventionNames': ['Combination Product: Placebo']}], 'interventions': [{'name': 'Chlorpheniramine Maleate 1% Nasal Spray', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['ClorNasal', 'ClorNovir'], 'description': 'Chlorpheniramine Maleate 1% Nasal Spray', 'armGroupLabels': ['Chlorpheniramine Malate (1%) Nasal Spray']}, {'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'Placebo nasal spray', 'armGroupLabels': ['Placebo Nasal Spray']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cortés', 'state': 'San Pedro Sula', 'country': 'Honduras', 'facility': 'Hospital CEMESA', 'geoPoint': {'lat': 15.63333, 'lon': -88.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Ferrer BioPharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital CEMESA Cortés, San Pedro Sula, Honduras', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}