The Effect of Recombinant Human Interferon Alpha Nasal Drops to Prevent COVID-19 Pneumonia for Medical Staff in an Epidemic Area

  1. Zhongji Meng
  2. Tongyu Wang
  3. Li Chen
  4. Xinhe Chen
  5. Longti Li
  6. Xueqin Qin
  7. Hai Li
  8. Jie Luo

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Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), known as Coronavirus disease-2019 (COVID-19), has caused the sixth world’s public health emergency. Healthcare staff, as the frontline population fighting the pandemic, are exposed to a high risk of infection. Therefore, developing a protective intervention for medical staff is of significant importance.

Objective:

The aim of the study was to explore the effectiveness and safety of recombinant human interferon alpha (rhIFN-α) nasal drops for the prevention of coronavirus disease 2019 (COVID-19) through administering it to medical staff.

Methods:

This was a prospective open-label clinical trial with parallel intervention assignment conducted on 2944 medical staff including both doctors and nurses from Taihe Hospital, Shiyan City, Hubei Province, China from January 21, 2020 to July 30, 2020. The participants were bifurcated into two groups of low risk and high risk groups according to the level of direct exposure to COVID-19 patients. The individuals of the low-risk group received rhIFN-α nasal drops for one month in addition to first level protection, and the high-risk group received a combination of rhIFN-α nasal drops coupled with thymosin-α1 with either second or third-level protection protocol. Moreover, the new-outset of COVID-19 pneumonia diagnosed by chest computed tomography (CT), after thirty days, was the primary outcome. The adverse reactions were recorded in all participants.

Results:

2415 of 2944 individuals belonged to the low-risk group, while 529 to the high-risk group. There was no COVID-19 pneumonia in either of the group after thirty days. The pulmonary CT scans were negative for COVID-19 pneumonia in both the groups with no new clinical symptoms. No serious adverse event was observed during the course of the intervention.

Conclusion:

The rhIFN-α nasal drops along with augmented safeguards based on standard physical isolation could effectively protect medical staff against COVID-19 pneumonia.

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  1. Version published to 10.2174/1568026621666210429083050
  2. ScreenIT

    SciScore for 10.1101/2020.04.11.20061473: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was approved by the Medical Ethics Committee of Taihe Hospital, Shiyan City.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variableExclusion criteria: Participants who met the following conditions were excluded: pregnant women, those with severe chronic illnesses who were unable to participate in normal health care work, those with acute fever (>37.2 centigrade) and/or respiratory symptoms who were unwilling to receive IFN-α nasal drops or thymosin-α1.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Our study also has limitations. The study was not clustered, randomized designed with the control group from other epidemic area during the same period reported in the literature, rather than a strictly parallel, placebo-controlled group. Nevertheless, our study represents a real-world effort initiated by researchers in an emergent medical situation to prevent and control nosocomial infection in our medical staff. The results lay a good foundation for subsequent high-quality randomized, parallel, placebo-controlled studies. Secondly, SARS-CoV-2 nucleic acid tests and serum antibodies tests were not performed for the subjects in this study, so it was impossible to determine whether IFN-α has prevents infection with SARS-CoV-2; instead, the development of COVID-19 pneumonia was the main evaluation indicator. The main reason for using this outcome was that no COVID-19 diagnostic kits had been approved at the beginning of the study. Subsequent high-quality studies should use combined nucleic acid and serum antibody testing to diagnose SARS-CoV-2 infection. In summary, in more than 2,000 health care workers at large tertiary hospitals who were at high or low risk of exposure to SARS-CoV-2 in Shiyan City, Hubei Province, a COVID-19 epidemic area, a real-world study of the use of IFN-α nasal drops with or without thymosin-α1 as a 28-day intervention shows that low-risk subjects treated with IFN-α nasal drops alone and high-risk subjects treated with IFN-α nasal drops combined with t...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04320238RecruitingExperimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCO…

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

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  3. Version published to 10.1101/2020.04.11.20061473 on medRxiv