A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19

Autor: Mir Saeed Yekaninejad, Mahboubeh Hajiabdolbaghi, Mohamadreza Salehi, Ladan Abbasian, Effat Davoudi-Monfared, Hamid Rahmani, Hossein Kazemzadeh, Hossein Khalili
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
Comorbidity
clinical response
Lopinavir
law.invention
0302 clinical medicine
Randomized controlled trial
law
Neoplasms
Pharmacology (medical)
030212 general & internal medicine
interferon beta
Letter to the Editor
0303 health sciences
virus diseases
interferon
Middle Aged
Intensive care unit
Drug Combinations
Intensive Care Units
Treatment Outcome
Infectious Diseases
Cardiovascular Diseases
Drug Therapy
Combination
Female
Patient Safety
Coronavirus Infections
Interferon beta-1a
Hydroxychloroquine
medicine.drug
Adult
medicine.medical_specialty
Atazanavir Sulfate
Pneumonia
Viral
Antiviral Agents
Drug Administration Schedule
Betacoronavirus
03 medical and health sciences
Internal medicine
Diabetes Mellitus
medicine
Humans
Adverse effect
Pandemics
Survival analysis
Aged
Dyslipidemias
030304 developmental biology
Pharmacology
Ritonavir
SARS-CoV-2
business.industry
COVID-19
Odds ratio
Length of Stay
Editor's Pick
Survival Analysis
mortality
Clinical trial
biotherapy
business
Zdroj: Antimicrobial Agents and Chemotherapy
ISSN: 1098-6596
0066-4804
DOI: 10.1128/aac.01061-20
Popis: 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.
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.)
Databáze: OpenAIRE
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