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
NCT ID: NCT04343768
Last Updated: 2020-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2020-04-09
2020-04-27
Brief Summary
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Detailed Description
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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 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.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Patients 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.
TREATMENT
NONE
Study Groups
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Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a
Hydroxychloroquine
This Drug will be used in all arms.
Lopinavir / Ritonavir
This Drug will be used in all arms.
Interferon Beta-1A
This drug will be only used in Arm 1.
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b
Hydroxychloroquine
This Drug will be used in all arms.
Lopinavir / Ritonavir
This Drug will be used in all arms.
Interferon Beta-1B
This drug will be only used in Arm 2.
Control group: hydroxychloroquine + Lopinavir / Ritonavir
Hydroxychloroquine
This Drug will be used in all arms.
Lopinavir / Ritonavir
This Drug will be used in all arms.
Interventions
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Hydroxychloroquine
This Drug will be used in all arms.
Lopinavir / Ritonavir
This Drug will be used in all arms.
Interferon Beta-1A
This drug will be only used in Arm 1.
Interferon Beta-1B
This drug will be only used in Arm 2.
Eligibility Criteria
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Inclusion Criteria
* COVID-19 Confirmed Cases By Means of RT-PCR
* Oxygen saturation (SPO2) ≤ 93% OR respiratory rate ≥ 24
* 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.
* Time of onset of the symptoms should be acute ( Days ≤ 14)
Exclusion Criteria
* Patients with prolonged QT or PR intervals, Second or Third Degree heart block, Arrhythmias including torsade de pointes
* Patients using drugs with potential interaction with Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a، Interferon-β 1b.
* Pregnant or lactating women.
* History of alcohol or drug addiction in the past 5 years.
* Blood ALT/AST levels \> 5 times the upper limit of normal on laboratory results.
18 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Seyed Sina Naghibi Irvani, MD, MPH, MBA, Senior Researcher.
Dr.
Principal Investigators
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Ilad Alavi Darazam, MD
Role: STUDY_CHAIR
Shahid Beheshti University of Medical Sciences
Shervin Shokouhi, MD
Role: STUDY_DIRECTOR
Shahid Beheshti University of Medical Sciences
Minoosh Shabani, MD
Role: PRINCIPAL_INVESTIGATOR
Shahid Beheshti University of Medical Sciences
Mohammadreza Haji Esmaelie, MD
Role: PRINCIPAL_INVESTIGATOR
Shahid Beheshti University of Medical Sciences
Seyed Sina Naghibi Irvani, MD, MPH, MBA
Role: PRINCIPAL_INVESTIGATOR
Shahid Beheshti University of Medical Sciences
Locations
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Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services
Tehran, , Iran
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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Different Interferons in COVID
Identifier Type: -
Identifier Source: org_study_id
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