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

NCT04343768 | Completed Phase 2 DMC

• 1 other identifier: Different Interferons in COVID
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19; Novel Coronavirus; Interferon Beta 1a; Interferon Beta 1b

Outcome Measures

Primary Outcomes (1)

• Time to clinical improvement

  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.

  From date of randomization until 14 days later.

Secondary Outcomes (4)

• Mortality

  From date of randomization until 14 days later.

• SpO2 Improvement

  Days 1, 2, 3, 4, 5, 6, 7 and 14.

• Incidence of new mechanical ventilation use

  From date of randomization until 14 days later.

• Duration of hospitalization

  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.

Study Arms (3)

Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a

EXPERIMENTAL

Drug: Hydroxychloroquine; Drug: Lopinavir / Ritonavir; Drug: Interferon Beta-1A

Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b

EXPERIMENTAL

Drug: Hydroxychloroquine; Drug: Lopinavir / Ritonavir; Drug: Interferon Beta-1B

Control group: hydroxychloroquine + Lopinavir / Ritonavir

ACTIVE COMPARATOR

Drug: Hydroxychloroquine; Drug: Lopinavir / Ritonavir

Interventions

Hydroxychloroquine DRUG

This Drug will be used in all arms.

Control group: hydroxychloroquine + Lopinavir / Ritonavir; Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a; Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b

Lopinavir / Ritonavir DRUG

This Drug will be used in all arms.

Control group: hydroxychloroquine + Lopinavir / Ritonavir; Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a; Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b

Interferon Beta-1A DRUG

This drug will be only used in Arm 1.

Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a

Interferon Beta-1B DRUG

This drug will be only used in Arm 2.

Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• 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)

You may not qualify if:

• Refusal to participate expressed by patient or legally authorized representative if they are present
• 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.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services

Tehran, Iran

Location

Related Publications (10)

• 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: 32083985 BACKGROUND

• 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: 32007145 BACKGROUND

• 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: 31967327 BACKGROUND

• 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: 15135736 BACKGROUND

• 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: 28466096 BACKGROUND

• 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: 12892961 BACKGROUND

• 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: 15030704 BACKGROUND

• 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: 32149772 BACKGROUND

• 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: 33850184 DERIVED

• 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.

  PMID: 32493468 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Lopinavir; Interferon beta-1a; Interferon beta-1b

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ilad Alavi Darazam, MD

  Shahid Beheshti University of Medical Sciences

  STUDY CHAIR

• Shervin Shokouhi, MD

  Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

• Minoosh Shabani, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mohammadreza Haji Esmaelie, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Seyed Sina Naghibi Irvani, MD, MPH, MBA

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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. 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.

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: April 9, 2020
• Primary Completion: April 27, 2020
• Study Completion: April 27, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One year after the publication of the results in a journal.
• Access Criteria: 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.

Locations

IR (1)