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):e01061-20. doi: 10.1128/AAC.01061-20. Print 2020 Aug 20.

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.).

Keywords: COVID-19; clinical response; interferon; mortality.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antiviral Agents / therapeutic use*
  • Atazanavir Sulfate / therapeutic use*
  • Betacoronavirus / drug effects*
  • Betacoronavirus / immunology
  • Betacoronavirus / pathogenicity
  • Cardiovascular Diseases / drug therapy
  • Cardiovascular Diseases / immunology
  • Cardiovascular Diseases / mortality
  • Cardiovascular Diseases / virology
  • Comorbidity
  • Coronavirus Infections / drug therapy*
  • 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
  • Interferon beta-1a / therapeutic use*
  • Length of Stay
  • Lopinavir / therapeutic use*
  • Male
  • Middle Aged
  • Neoplasms / drug therapy
  • Neoplasms / immunology
  • Neoplasms / mortality
  • Neoplasms / virology
  • Pandemics
  • Patient Safety
  • Pneumonia, Viral / drug therapy*
  • Pneumonia, Viral / immunology
  • Pneumonia, Viral / mortality
  • Pneumonia, Viral / virology
  • Ritonavir / therapeutic use*
  • Survival Analysis
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Drug Combinations
  • lopinavir-ritonavir drug combination
  • Lopinavir
  • Atazanavir Sulfate
  • Hydroxychloroquine
  • Ritonavir
  • Interferon beta-1a

Supplementary concepts

  • COVID-19
  • severe acute respiratory syndrome coronavirus 2