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Randomized Controlled Trial
. 2021 Dec;53(1):391-401.
doi: 10.1080/07853890.2021.1890329.

Effect of a genetically engineered interferon-alpha versus traditional interferon-alpha in the treatment of moderate-to-severe COVID-19: a randomised clinical trial

Chuan Li  1 , Fengming Luo  2 , Chengwu Liu  1 , Nian Xiong  3   4 , Zhihua Xu  5 , Wei Zhang  6   7 , Ming Yang  8 , Ye Wang  2 , Dan Liu  2 , Chao Yu  7   9 , Jia Zeng  7   10 , Li Zhang  11 , Duo Li  12 , Yanbin Liu  13 , Mei Feng  2 , Ruoyang Liu  14 , Jiandong Mei  1 , Senyi Deng  1 , Zhen Zeng  1 , Yuanhong He  15 , Haiyan Liu  16 , Zhengyu Shi  16 , Meng Duan  17 , Deying Kang  18 , Jiayu Liao  19   20 , Weimin Li  2 , Lunxu Liu  1
Affiliations
Randomized Controlled Trial

Effect of a genetically engineered interferon-alpha versus traditional interferon-alpha in the treatment of moderate-to-severe COVID-19: a randomised clinical trial

Chuan Li et al. Ann Med. 2021 Dec.

Abstract

Background: There are few effective therapies for coronavirus disease 2019 (COVID-19) upon the outbreak of the pandemic. To compare the effectiveness of a novel genetically engineered recombinant super-compound interferon (rSIFN-co) with traditional interferon-alpha added to baseline antiviral agents (lopinavir-ritonavir or umifenovir) for the treatment of moderate-to-severe COVID-19.

Method: In this multicenter randomized (1:1) trial, patients hospitalized with moderate-to-severe COVID-19 received either rSIFN-co nebulization or interferon-alpha nebulization added to baseline antiviral agents for no more than 28 days. The primary endpoint was the time to clinical improvement. Secondary endpoints included the overall rate of clinical improvement assessed on day 28, the time to radiological improvement and virus nucleic acid negative conversion.

Results: A total of 94 patients were included in the safety set (46 patients assigned to rSIFN-co group, 48 to interferon-alpha group). The time to clinical improvement was 11.5 days versus 14.0 days (95% CI 1.10 to 2.81, p = .019); the overall rate of clinical improvement on day 28 was 93.5% versus 77.1% (difference, 16.4%; 95% CI 3% to 30%); the time to radiological improvement was 8.0 days versus 10.0 days (p = .002), the time to virus nucleic acid negative conversion was 7.0 days versus 10.0 days (p = .018) in the rSIFN-co and interferon alpha arms, respectively. Adverse events were balanced with no deaths among groups.

Conclusions and relevance: rSIFN-co was associated with a shorter time of clinical improvement than traditional interferon-alpha in the treatment of moderate-to-severe COVID-19 when combined with baseline antiviral agents. rSIFN-co therapy alone or combined with other antiviral therapy is worth to be further studied.Key messagesThere are few effective therapies for coronavirus disease 2019 (COVID-19) upon the outbreak of the pandemic. Interferon alphas, by inducing both innate and adaptive immune responses, have shown clinical efficacy in treating severe acute respiratory syndrome coronavirus and Middle East respiratory syndrome coronavirus.In this multicenter, head-to-head, randomized, clinical trial which included 94 participants with moderate-to-severe COVID-19, the rSIFN-co plus antiviral agents (lopinavir-ritonavir or umifenovir) was associated with a shorter time of clinical improvement than interferon-alpha plus antiviral agents.

Keywords: COVID-19; SARS-CoV-2; interferon-alpha; recombinant super-compound interferon; treatment.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1.
Figure 1.
Trial profile.
Figure 2.
Figure 2.
Outcomes over time. (A) Time to clinical improvement; (B) Time to radiological improvement on chest CT scans; (C) Time to virus negative conversion. Analysis was performed by log-rank (Mantel-Cox) test.
See this image and copyright information in PMC

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