Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
Study NCT ID:
NCT04637906
Status:
UNKNOWN
Last Update Posted:
2021-03-16
First Post:
2020-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short and Long-term Effects of Adding Oral L-arginine to Standard Therapy in Patients With COVID-19 (SARS-CoV-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-06-23', 'releaseDate': '2021-06-16'}, {'resetDate': '2021-06-24', 'releaseDate': '2021-06-24'}, {'resetDate': '2021-09-22', 'releaseDate': '2021-09-20'}, {'resetDate': '2021-10-01', 'releaseDate': '2021-09-30'}, {'resetDate': '2023-02-02', 'releaseDate': '2022-05-04'}], 'estimatedResultsFirstSubmitDate': '2021-06-16'}}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 290}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-09-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of P / F normalization times', 'timeFrame': '60 days', 'description': 'Alveolar pressure of oxygen / inspiratory fraction of oxygen'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '34522871', 'type': 'DERIVED', 'citation': 'Fiorentino G, Coppola A, Izzo R, Annunziata A, Bernardo M, Lombardi A, Trimarco V, Santulli G, Trimarco B. Effects of adding L-arginine orally to standard therapy in patients with COVID-19: A randomized, double-blind, placebo-controlled, parallel-group trial. Results of the first interim analysis. EClinicalMedicine. 2021 Oct;40:101125. doi: 10.1016/j.eclinm.2021.101125. Epub 2021 Sep 9.'}]}, 'descriptionModule': {'briefSummary': "Single-center study with a parallel group scheme, double-blind, randomized, placebo-controlled, to evaluate whether the addition to the investigator's hospital standard therapy of two vials of Bioarginina® per day in subjects with SARS-CoV-2 is useful for treatment of this pathology.", 'detailedDescription': 'Preliminary experiences conducted in patients affected by SARS-CoV-2 infection by adding the daily oral administration of two vials of Bioarginina® to the standard therapy have shown favorable effects on discharge times, on the recovery of the number of lymphocytes and on the P \\\\ F ratio between arterial pO2 and FiO2 breathed. In particular, for the latter parameter there is almost a doubling of the recovery speed.\n\nThe investigators therefore, decided to undertake the present spontaneous, single-center study with a parallel group scheme, double-blind randomized, placebo-controlled to evaluate whether the addition to the standard therapy of two vials per day of Bioarginina® in subjects of our hospital suffering from SARS-CoV-2 is useful for the treatment of this pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\> 18 years\n* Diagnosis of COVID 19, confirmed by RT-PCR on a nasopharyngeal swab\n* COVID 19 pneumonia with the following clinical characteristics: SpO2 in ambient air \\<93% and Alveolar pressure of oxygen / inspiratory fraction of oxygen (PaO2 / FiO2 - P / F \\<300 mmHg.\n* Lymphocytopenia defined as lymphocytes \\<1500 / mcL or \\<20% of white blood cells\n\nExclusion Criteria:\n\n* History of intolerance to L-arginine\n* Severe chronic pulmonary disease\n* Pregnancy or breastfeeding\n* Neutropenia due to neoplasms of the haematopoietic system or other organs with invasion of the bone marrow\n* Use of immunosuppressive drugs or cytotoxic chemotherapies within the previous three weeks\n* Refusal to give consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT04637906', 'briefTitle': 'Short and Long-term Effects of Adding Oral L-arginine to Standard Therapy in Patients With COVID-19 (SARS-CoV-2)', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Short and Long-term Effects of Adding Oral L-arginine to Standard Therapy in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Randomized, Parallel Group, Double-blind Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Bioarginina'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-arginine', 'description': 'Bioarginina®, 2 orally administered vials per day', 'interventionNames': ['Dietary Supplement: Bioarginina®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 orally administered vials per day of Bioarginina® without L-arginine', 'interventionNames': ['Dietary Supplement: Bioarginina®']}], 'interventions': [{'name': 'Bioarginina®', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Food supplement based on 1,66 grams of L-arginine', 'armGroupLabels': ['L-arginine', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80123', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'barbara maglione', 'role': 'CONTACT', 'email': 'bmaglione@hotmail.com', 'phone': '3343293357'}], 'facility': 'Azienda Ospedaliera Specialistica Dei Colli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'centralContacts': [{'name': 'barbara maglione', 'role': 'CONTACT', 'email': 'bmaglione@hotmail.com', 'phone': '3343293357', 'phoneExt': '3343293357'}], 'overallOfficials': [{'name': 'Giuseppe Fiorentino', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Campania Luigi Vanvitelli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'giuseppe fiorentino', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-06-16', 'type': 'RELEASE'}, {'date': '2021-06-23', 'type': 'RESET'}, {'date': '2021-06-24', 'type': 'RELEASE'}, {'date': '2021-06-24', 'type': 'RESET'}, {'date': '2021-09-20', 'type': 'RELEASE'}, {'date': '2021-09-22', 'type': 'RESET'}, {'date': '2021-09-30', 'type': 'RELEASE'}, {'date': '2021-10-01', 'type': 'RESET'}, {'date': '2022-05-04', 'type': 'RELEASE'}, {'date': '2023-02-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'giuseppe fiorentino, PROFESSOR, University of Campania Luigi Vanvitelli'}}}}