Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 12:04 AM
Study NCT ID:
NCT04343768
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2020-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D000068556', 'term': 'Interferon beta-1a'}, {'id': 'D000068576', 'term': 'Interferon beta-1b'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study.\n\nPatients will be allocated to three therapeutic arms (Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a group and Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b group and the Base Therapeutic Regiment Group, i.e., Hydropinchloroquine + / Ritonavir. For this purpose, we will use the method of Balance Block Randomization for three groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-02', 'studyFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to clinical improvement', 'timeFrame': 'From date of randomization until 14 days later.', 'description': 'Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R\\&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'From date of randomization until 14 days later.', 'description': 'If the patient dies, we have reached an outcome.'}, {'measure': 'SpO2 Improvement', 'timeFrame': 'Days 1, 2, 3, 4, 5, 6, 7 and 14.', 'description': 'Pulse-oxymetry'}, {'measure': 'Incidence of new mechanical ventilation use', 'timeFrame': 'From date of randomization until 14 days later.', 'description': 'Incidence of new mechanical ventilation use'}, {'measure': 'Duration of hospitalization', 'timeFrame': 'From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.', 'description': 'Duration of hospitalization (days)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Novel Coronavirus', 'Interferon Beta 1a', 'Interferon Beta 1b'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32083985', 'type': 'BACKGROUND', 'citation': 'Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Aug;296(2):E15-E25. doi: 10.1148/radiol.2020200490. Epub 2020 Feb 21.'}, {'pmid': '32007145', 'type': 'BACKGROUND', 'citation': 'Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.'}, {'pmid': '31967327', 'type': 'BACKGROUND', 'citation': 'Chen Y, Liu Q, Guo D. Emerging coronaviruses: Genome structure, replication, and pathogenesis. J Med Virol. 2020 Apr;92(4):418-423. doi: 10.1002/jmv.25681. Epub 2020 Feb 7.'}, {'pmid': '15135736', 'type': 'BACKGROUND', 'citation': 'Spiegel M, Pichlmair A, Muhlberger E, Haller O, Weber F. The antiviral effect of interferon-beta against SARS-coronavirus is not mediated by MxA protein. J Clin Virol. 2004 Jul;30(3):211-3. doi: 10.1016/j.jcv.2003.11.013.'}, {'pmid': '28466096', 'type': 'BACKGROUND', 'citation': 'Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.'}, {'pmid': '12892961', 'type': 'BACKGROUND', 'citation': 'Cinatl J, Morgenstern B, Bauer G, Chandra P, Rabenau H, Doerr HW. Treatment of SARS with human interferons. Lancet. 2003 Jul 26;362(9380):293-4. doi: 10.1016/s0140-6736(03)13973-6.'}, {'pmid': '15030704', 'type': 'BACKGROUND', 'citation': 'Hensley LE, Fritz LE, Jahrling PB, Karp CL, Huggins JW, Geisbert TW. Interferon-beta 1a and SARS coronavirus replication. Emerg Infect Dis. 2004 Feb;10(2):317-9. doi: 10.3201/eid1002.030482.'}, {'pmid': '32149772', 'type': 'BACKGROUND', 'citation': 'Zeng YM, Xu XL, He XQ, Tang SQ, Li Y, Huang YQ, Harypursat V, Chen YK. Comparative effectiveness and safety of ribavirin plus interferon-alpha, lopinavir/ritonavir plus interferon-alpha, and ribavirin plus lopinavir/ritonavir plus interferon-alpha in patients with mild to moderate novel coronavirus disease 2019: study protocol. Chin Med J (Engl). 2020 May 5;133(9):1132-1134. doi: 10.1097/CM9.0000000000000790. No abstract available.'}, {'pmid': '33850184', 'type': 'DERIVED', 'citation': 'Alavi Darazam I, Shokouhi S, Pourhoseingholi MA, Naghibi Irvani SS, Mokhtari M, Shabani M, Amirdosara M, Torabinavid P, Golmohammadi M, Hashemi S, Azimi A, Jafarazadeh Maivan MH, Rezaei O, Zali A, Hajiesmaeili M, Shabanpour Dehbsneh H, Hoseyni Kusha A, Taleb Shoushtari M, Khalili N, Soleymaninia A, Gachkar L, Khoshkar A. Role of interferon therapy in severe COVID-19: the COVIFERON randomized controlled trial. Sci Rep. 2021 Apr 13;11(1):8059. doi: 10.1038/s41598-021-86859-y.'}, {'pmid': '32493468', 'type': 'DERIVED', 'citation': 'Irvani SSN, Golmohammadi M, Pourhoseingholi MA, Shokouhi S, Darazam IA. Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Jun 3;21(1):473. doi: 10.1186/s13063-020-04382-3.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1101/2020.02.03.20020263', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.', 'detailedDescription': 'According to previous studies, IFN-β has strong antiviral activity and also has an acceptable safety profile. Based on possible therapeutic effects, We decided to lead An Investigation into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19. In a 2003 study, SARS was treated with different human interferons and found that IFN-β was 5 to 10 times more effective than other types of interferons and the strongest antiviral drug possible against SARS-CoV.\n\nThe present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran.\n\nPatients will be allocated to three therapeutic arms (Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a group and Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b group and the Base Therapeutic Regiment Group, i.e., Hydropinchloroquine + / Ritonavir. For this purpose, we will use the method of Balance Block Randomization for three groups.\n\nAfter completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* COVID-19 Confirmed Cases By Means of RT-PCR\n* Oxygen saturation (SPO2) ≤ 93% OR respiratory rate ≥ 24\n* At least one of the following: Calibrated contactless infrared forehead thermometry temperature of ≥37.8, cough, sputum production, nasal discharge, myalgia, headache or fatigue on admission.\n* Time of onset of the symptoms should be acute ( Days ≤ 14)\n\nExclusion Criteria:\n\n* Refusal to participate expressed by patient or legally authorized representative if they are present\n* Patients with prolonged QT or PR intervals, Second or Third Degree heart block, Arrhythmias including torsade de pointes\n* Patients using drugs with potential interaction with Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a، Interferon-β 1b.\n* Pregnant or lactating women.\n* History of alcohol or drug addiction in the past 5 years.\n* Blood ALT/AST levels \\> 5 times the upper limit of normal on laboratory results.'}, 'identificationModule': {'nctId': 'NCT04343768', 'acronym': 'COVIFERON', 'briefTitle': 'An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Different Interferons in COVID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a', 'interventionNames': ['Drug: Hydroxychloroquine', 'Drug: Lopinavir / Ritonavir', 'Drug: Interferon Beta-1A']}, {'type': 'EXPERIMENTAL', 'label': 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b', 'interventionNames': ['Drug: Hydroxychloroquine', 'Drug: Lopinavir / Ritonavir', 'Drug: Interferon Beta-1B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group: hydroxychloroquine + Lopinavir / Ritonavir', 'interventionNames': ['Drug: Hydroxychloroquine', 'Drug: Lopinavir / Ritonavir']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'This Drug will be used in all arms.', 'armGroupLabels': ['Control group: hydroxychloroquine + Lopinavir / Ritonavir', 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a', 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b']}, {'name': 'Lopinavir / Ritonavir', 'type': 'DRUG', 'description': 'This Drug will be used in all arms.', 'armGroupLabels': ['Control group: hydroxychloroquine + Lopinavir / Ritonavir', 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a', 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b']}, {'name': 'Interferon Beta-1A', 'type': 'DRUG', 'description': 'This drug will be only used in Arm 1.', 'armGroupLabels': ['Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a']}, {'name': 'Interferon Beta-1B', 'type': 'DRUG', 'description': 'This drug will be only used in Arm 2.', 'armGroupLabels': ['Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Ilad Alavi Darazam, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}, {'name': 'Shervin Shokouhi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}, {'name': 'Minoosh Shabani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}, {'name': 'Mohammadreza Haji Esmaelie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}, {'name': 'Seyed Sina Naghibi Irvani, MD, MPH, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'One year after the publication of the results in a journal.', 'ipdSharing': 'YES', 'description': 'One year after the publication of the results in a journal, Qualifying researchers who reach out to Dr. Seyed Sina Naghibi Irvani at "sina.irvani@sbmu.ac.ir" or "sina.irvani@gmail.com" and submit a proposal with a valuable research question can have access to data and supporting information.', 'accessCriteria': 'Qualifying researchers who reach out to Dr. Seyed Sina Naghibi Irvani at "sina.irvani@sbmu.ac.ir" or "sina.irvani@gmail.com" and submit a proposal with a valuable research question.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Seyed Sina Naghibi Irvani, MD, MPH, MBA, Senior Researcher.', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}