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A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19.
Antimicrob Agents Chemother. 2020 Aug 20; 64(9)AA

Abstract

To the best of our knowledge, there is no published study on the use of interferon β-1a (IFN β-1a) in the treatment of severe COVID-19. In this randomized clinical trial, the efficacy and safety of IFN β-1a were evaluated in patients with severe COVID-19. Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir-ritonavir or atazanavir-ritonavir). Each 44-μg/ml (12 million IU/ml) dose of interferon β-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group consisted of 39 patients who received only the national protocol medications. The primary outcome of the study was time to reach clinical response. Secondary outcomes were duration of hospital stay, length of intensive care unit stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects, and complications during the hospitalization. Between 29 February and 3 April 2020, 92 patients were recruited, and a total of 42 patients in the IFN group and 39 patients in the control group completed the study. As the primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 ± 5.8 versus 8.3 ± 4.9 days, respectively, P = 0.95). On day 14, 66.7% versus 43.6% of patients in the IFN group and the control group, respectively, were discharged (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.05 to 6.37). The 28-day overall mortality was significantly lower in the IFN than the control group (19% versus 43.6%, respectively, P = 0.015). Early administration significantly reduced mortality (OR, 13.5; 95% CI, 1.5 to 118). Although IFN did not change the time to reach the clinical response, adding it to the national protocol significantly increased discharge rate on day 14 and decreased 28-day mortality. (This study is in the Iranian Registry of Clinical Trials under identifier IRCT20100228003449N28.).

Authors+Show Affiliations

Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran Khalilih@sina.tums.ac.ir.Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.Advanced Thoracic Research Center, Occupational Sleep Research Center, Tehran University of Medical Sciences, Tehran, Iran.Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

32661006

Citation

Davoudi-Monfared, Effat, et al. "A Randomized Clinical Trial of the Efficacy and Safety of Interferon Β-1a in Treatment of Severe COVID-19." Antimicrobial Agents and Chemotherapy, vol. 64, no. 9, 2020.
Davoudi-Monfared E, Rahmani H, Khalili H, et al. A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19. Antimicrob Agents Chemother. 2020;64(9).
Davoudi-Monfared, E., Rahmani, H., Khalili, H., Hajiabdolbaghi, M., Salehi, M., Abbasian, L., Kazemzadeh, H., & Yekaninejad, M. S. (2020). A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19. Antimicrobial Agents and Chemotherapy, 64(9). https://doi.org/10.1128/AAC.01061-20
Davoudi-Monfared E, et al. A Randomized Clinical Trial of the Efficacy and Safety of Interferon Β-1a in Treatment of Severe COVID-19. Antimicrob Agents Chemother. 2020 Aug 20;64(9) PubMed PMID: 32661006.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19. AU - Davoudi-Monfared,Effat, AU - Rahmani,Hamid, AU - Khalili,Hossein, AU - Hajiabdolbaghi,Mahboubeh, AU - Salehi,Mohamadreza, AU - Abbasian,Ladan, AU - Kazemzadeh,Hossein, AU - Yekaninejad,Mir Saeed, Y1 - 2020/08/20/ PY - 2020/5/25/received PY - 2020/7/10/accepted PY - 2020/7/15/pubmed PY - 2020/9/4/medline PY - 2020/7/15/entrez KW - COVID-19 KW - clinical response KW - interferon KW - mortality JF - Antimicrobial agents and chemotherapy JO - Antimicrob Agents Chemother VL - 64 IS - 9 N2 - To the best of our knowledge, there is no published study on the use of interferon β-1a (IFN β-1a) in the treatment of severe COVID-19. In this randomized clinical trial, the efficacy and safety of IFN β-1a were evaluated in patients with severe COVID-19. Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir-ritonavir or atazanavir-ritonavir). Each 44-μg/ml (12 million IU/ml) dose of interferon β-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group consisted of 39 patients who received only the national protocol medications. The primary outcome of the study was time to reach clinical response. Secondary outcomes were duration of hospital stay, length of intensive care unit stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects, and complications during the hospitalization. Between 29 February and 3 April 2020, 92 patients were recruited, and a total of 42 patients in the IFN group and 39 patients in the control group completed the study. As the primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 ± 5.8 versus 8.3 ± 4.9 days, respectively, P = 0.95). On day 14, 66.7% versus 43.6% of patients in the IFN group and the control group, respectively, were discharged (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.05 to 6.37). The 28-day overall mortality was significantly lower in the IFN than the control group (19% versus 43.6%, respectively, P = 0.015). Early administration significantly reduced mortality (OR, 13.5; 95% CI, 1.5 to 118). Although IFN did not change the time to reach the clinical response, adding it to the national protocol significantly increased discharge rate on day 14 and decreased 28-day mortality. (This study is in the Iranian Registry of Clinical Trials under identifier IRCT20100228003449N28.). SN - 1098-6596 UR - https://www.unboundmedicine.com/medline/citation/32661006/A_Randomized_Clinical_Trial_of_the_Efficacy_and_Safety_of_Interferon_β_1a_in_Treatment_of_Severe_COVID_19_ DB - PRIME DP - Unbound Medicine ER -