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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 randomly assigned to the two 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.
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 high-dose Interferon Beta 1a, Compared to low-dose Interferon Beta 1a (the base therapeutic regimen) in Moderate to Severe COVID-19.
Previous studies demonstrate that IFN-β 1a could be used against some coronaviruses including avium infectious, bronchitis virus, murine hepatitis virus, and SARS- CoV because they are susceptible in vitro or in vivo. In a current study, the efficacy of IFN-β 1a in COVID-19 patients were evaluated, and they found than IFN-β 1a reduced the disease symptoms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 | Experimental | Lopinavir /Ritonavir +high dose Interferon-β 1a |
|
| Arm2 | Experimental | Lopinavir /Ritonavir + Low dose Interferon-β 1a |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose Interferon-beta 1a | Drug | High dose IFN-β1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | If the patient dies, we have reached an outcome | From date of randomization until 14 days later |
| SpO2 Improvement | Pulse-oxymetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilad Alavi Darazam, MD | Contact | +98-914-149-1958 | ilad13@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ilad Alavi Darazam, M.D | Shahid Beheshti University of Medical Sciences | Study Chair |
| Firouze Hatami, M.D | Shahid Beheshti University of Medical Sciences | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32132184 | Background | Yan R, Zhang Y, Li Y, Xia L, Guo Y, Zhou Q. Structural basis for the recognition of SARS-CoV-2 by full-length human ACE2. Science. 2020 Mar 27;367(6485):1444-1448. doi: 10.1126/science.abb2762. Epub 2020 Mar 4. | |
| 32221306 | Background | Ou X, Liu Y, Lei X, Li P, Mi D, Ren L, Guo L, Guo R, Chen T, Hu J, Xiang Z, Mu Z, Chen X, Chen J, Hu K, Jin Q, Wang J, Qian Z. Characterization of spike glycoprotein of SARS-CoV-2 on virus entry and its immune cross-reactivity with SARS-CoV. Nat Commun. 2020 Mar 27;11(1):1620. doi: 10.1038/s41467-020-15562-9. |
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| Lopinavir/Ritonavir | Drug | Lopinavir/Ritonavir (Kaletra) [IFN-β1a group] (400mg/100 mg twice a day for 10 days |
|
| Low dose Interferon-beta 1a | Drug | Low doseIFN-β1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6) |
|
| 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 |
| Cumulative incidence of serious adverse events | With the incidence of any serious adverse effects, the outcome has happened | Days 1, 2, 3, 4, 5, 6, 7 and 14 |
| Mohammad Mahdi Rabiei, M.D |
| Shahid Beheshti University of Medical Sciences |
| Principal Investigator |
| Omid Moradi | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Behnam Rahimi, M.D | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Shervin Shokouhi, M.D | Shahid Beheshti University of Medical Sciences | Study Director |
| Mohammad Reza Hajesmaeili, M.D | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Minoosh Shabani, M.D | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Seyed Sina Naghibi Irvani, M.D | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| 32203186 | Background | Zheng HY, Zhang M, Yang CX, Zhang N, Wang XC, Yang XP, Dong XQ, Zheng YT. Elevated exhaustion levels and reduced functional diversity of T cells in peripheral blood may predict severe progression in COVID-19 patients. Cell Mol Immunol. 2020 May;17(5):541-543. doi: 10.1038/s41423-020-0401-3. Epub 2020 Mar 17. No abstract available. |
| 31771760 | Background | Wang BX, Fish EN. Global virus outbreaks: Interferons as 1st responders. Semin Immunol. 2019 Jun;43:101300. doi: 10.1016/j.smim.2019.101300. |
| 32401715 | Background | Hung IF, Lung KC, Tso EY, Liu R, Chung TW, Chu MY, Ng YY, Lo J, Chan J, Tam AR, Shum HP, Chan V, Wu AK, Sin KM, Leung WS, Law WL, Lung DC, Sin S, Yeung P, Yip CC, Zhang RR, Fung AY, Yan EY, Leung KH, Ip JD, Chu AW, Chan WM, Ng AC, Lee R, Fung K, Yeung A, Wu TC, Chan JW, Yan WW, Chan WM, Chan JF, Lie AK, Tsang OT, Cheng VC, Que TL, Lau CS, Chan KH, To KK, Yuen KY. Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial. Lancet. 2020 May 30;395(10238):1695-1704. doi: 10.1016/S0140-6736(20)31042-4. Epub 2020 May 10. |
| 15030704 | 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. |
| 32544867 | Background | Dastan F, Nadji SA, Saffaei A, Marjani M, Moniri A, Jamaati H, Hashemian SM, Baghaei P, Abedini A, Varahram M, Yousefian S, Tabarsi P. Subcutaneous administration of interferon beta-1a for COVID-19: A non-controlled prospective trial. Int Immunopharmacol. 2020 Aug;85:106688. doi: 10.1016/j.intimp.2020.106688. Epub 2020 Jun 7. |
| 34224994 | Derived | Alavi Darazam I, Hatami F, Mahdi Rabiei M, Amin Pourhoseingholi M, Shabani M, Shokouhi S, Mardani M, Moradi O, Javandoust Gharehbagh F, Mirtalaee N, Negahban H, Amirdosara M, Zangi M, Hajiesmaeili M, Kazempour M, Shafigh N. An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a in severe COVID-19: The COVIFERON II randomized controlled trial. Int Immunopharmacol. 2021 Oct;99:107916. doi: 10.1016/j.intimp.2021.107916. Epub 2021 Jun 29. |
| 33106183 | Derived | Alavi Darazam I, Hatami F, Rabiei MM, Pourhoseingholi MA, Moradi O, Shokouhi S, Hajesmaeili MR, Shabani M, Irvani SSN. An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a (the base therapeutic regimen) in moderate to severe COVID-19: A structured summary of a study protocol for a randomized controlled l trial. Trials. 2020 Oct 26;21(1):880. doi: 10.1186/s13063-020-04812-2. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| D061466 | Lopinavir |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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