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

COVID-19 Clinical Trial

— COVIFERON  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343768
• Other study ID #: Different Interferons in COVID
• Status: Completed
• Phase: Phase 2
• Start date: April 9, 2020
• Est. completion date: April 27, 2020

Study information

• Verified date: May 2020
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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-ß 1a? Interferon-ß 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (8)

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. Review. — View 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. Review. — View 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. Erratum in: Lancet. 2003 Aug 30;362(9385):748. — View 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. — View 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. — View Citation

Spiegel M, Pichlmair A, Mühlberger 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. — View 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. — View 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 Feb 21:200490. doi: 10.1148/radiol.2020200490. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	If the patient dies, we have reached an outcome.	From date of randomization until 14 days later.
Secondary	SpO2 Improvement	Pulse-oxymetry	Days 1, 2, 3, 4, 5, 6, 7 and 14.
Secondary	Incidence of new mechanical ventilation use	Incidence of new mechanical ventilation use	From date of randomization until 14 days later.
Secondary	Duration of hospitalization	Duration of hospitalization (days)	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.

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