COVID-19 Evidence Alerts
from McMaster PLUSTM

Current best evidence for clinical care (more info)

Treatment Rahmani H, Davoudi-Monfared E, Nourian A, et al. Interferon beta-1b in treatment of severe COVID-19: A randomized clinical trial. Int Immunopharmacol. 2020 Aug 24;88:106903. doi: 10.1016/j.intimp.2020.106903.
Abstract

In this study, efficacy and safety of interferon (IFN) ß-1b in the treatment of patients with severe COVID-19 were evaluated. Among an open-label, randomized clinical trial, adult patients (=18 years old) with severe COVID-19 were randomly assigned (1:1) to the IFN group or the control group. Patients in the IFN group received IFN ß-1b (250 mcg subcutaneously every other day for two consecutive weeks) along with the national protocol medications while in the control group, patients received only the national protocol medications (lopinavir/ritonavir or atazanavir/ritonavir plus hydroxychloroquine for 7-10 days). The primary outcome of the study was time to clinical improvement. Secondary outcomes were in-hospital complications and 28-daymortality. Between April 20 and May 20, 2020, 80 patients were enrolled and finally 33 patients in each group completed the study. Time to clinical improvment in the IFN group was significantly shorter than the control group ([9(6-10) vs. 11(9-15) days respectively, p = 0.002, HR = 2.30; 95% CI: 1.33-3.39]). At day 14, the percentage of discharged patients was 78.79% and 54.55% in the IFN and control groups respectively (OR = 3.09; 95% CI: 1.05-9.11, p = 0.03). ICU admission rate in the control group was significantly higher than the IFN group (66.66% vs. 42.42%, p = 0.04). The duration of hospitalization and ICU stay were not significantly different between the groups All-cause 28-day mortality was 6.06% and 18.18% in the IFN and control groups respectively (p = 0.12). IFN ß-1b was effective in shortening the time to clinical improvement without serious adverse events in patients with severe COVID-19. Furthermore, admission in ICU and need for invasive mechanical ventilation decreased following administration of IFN ß-1b. Although 28-day mortality was lower in the IFN group, further randomized clinical trials with large sample size are needed for exact estimation of survival benefit of IFN ß-1b.

Ratings
Discipline / Specialty Area Score
Hospital Doctor/Hospitalists
Internal Medicine
Intensivist/Critical Care
Respirology/Pulmonology
Infectious Disease
Comments from MORE raters

Hospital Doctor/Hospitalists rater

The study warrants replication.

Internal Medicine rater

I am doubtful of the clinical relevance of the main outcome: Clinical improvement was defined as improvement of at least two points from the baseline status on the six-category ordinal scale [18]. Also, the ordinal nature of the scale is not taken into account by the analysis. https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30483-7/fulltext#seccestitle80

Respirology/Pulmonology rater

This is a study that evaluated the utility of Interferon B1b in severe COVID 19. While it showed benefit for this drug, it has several major limitations including the sample size and the use of other medications that are unproven (antivirals) or detrimental (HCQ) in COVID. Moreover, there was a significant difference in the rate of steroid use between groups. Overall, the conclusions need to be validated. I do not think the results are sufficient to influence clinical practice.

Respirology/Pulmonology rater

This is interesting and potentially important. It's probably underpowered to show difference in mortality. It is slightly behind the curve regarding other supportive treatments as neither this particular antiviral combination nor hydroxychloroquine have now been shown to be effective; whereas, the treatment that DOES work (dexamethasone) was sparsely used and any subsequent trial would have to include this for all participants.