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A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19.
- Source :
-
Antimicrobial agents and chemotherapy [Antimicrob Agents Chemother] 2020 Aug 20; Vol. 64 (9). Date of Electronic Publication: 2020 Aug 20 (Print Publication: 2020). - Publication Year :
- 2020
-
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.).<br /> (Copyright © 2020 American Society for Microbiology.)
- Subjects :
- Adult
Aged
Betacoronavirus immunology
Betacoronavirus pathogenicity
COVID-19
Cardiovascular Diseases drug therapy
Cardiovascular Diseases immunology
Cardiovascular Diseases mortality
Cardiovascular Diseases virology
Comorbidity
Coronavirus Infections immunology
Coronavirus Infections mortality
Coronavirus Infections virology
Diabetes Mellitus drug therapy
Diabetes Mellitus immunology
Diabetes Mellitus mortality
Diabetes Mellitus virology
Drug Administration Schedule
Drug Combinations
Drug Therapy, Combination
Dyslipidemias drug therapy
Dyslipidemias immunology
Dyslipidemias mortality
Dyslipidemias virology
Female
Humans
Hydroxychloroquine therapeutic use
Intensive Care Units
Length of Stay
Male
Middle Aged
Neoplasms drug therapy
Neoplasms immunology
Neoplasms mortality
Neoplasms virology
Pandemics
Patient Safety
Pneumonia, Viral immunology
Pneumonia, Viral mortality
Pneumonia, Viral virology
SARS-CoV-2
Survival Analysis
Treatment Outcome
Antiviral Agents therapeutic use
Atazanavir Sulfate therapeutic use
Betacoronavirus drug effects
Coronavirus Infections drug therapy
Interferon beta-1a therapeutic use
Lopinavir therapeutic use
Pneumonia, Viral drug therapy
Ritonavir therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1098-6596
- Volume :
- 64
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Antimicrobial agents and chemotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 32661006
- Full Text :
- https://doi.org/10.1128/AAC.01061-20