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Study Protocol of a Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in COVID-19 Patients with Comorbidities

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Abstract

Introduction

Ropeginterferon alfa-2b represents a new-generation PEGylated interferon. It is approved for the treatment of polycythemia vera and shows promising anti-SARS-CoV-2 activities.

Objective

This clinical study aims to evaluate the efficacy and safety of ropeginterferon alfa-2b in patients with coronavirus disease 2019 (COVID-19) and comorbidities.

Methods

The randomized controlled study is designed to enroll adult patients with COVID-19 infection and comorbidities. Patients are non-responders to anti-SARS-CoV-2 drugs or not suitable to receive them. Comorbidities include hematologic cancer, solid tumor, and well-controlled autoimmune disease. Non-responders to anti-SARS-CoV-2 drugs are defined as having received treatment but have a Ct value < 30 at 14 days after symptom onset. Patients are randomized in a 1:1 ratio to receive ropeginterferon alfa-2b at 250 μg plus standard of care (SOC) or SOC alone. SARS-CoV-2 antigen test will be conducted at day 15 and day 29 visits to determine whether to administer additional ropeginterferon alfa-2b doses. Patients who are positive on the antigen test on days 15 and 29 will receive the second and third doses of ropeginterferon alfa-2b at 350 μg and 500 μg, respectively. Patients with a negative antigen test but a Ct value < 30 by reverse transcription polymerase chain reaction (RT-PCR) at days 15 and 29 are also administered the second (350 μg) and third (500 μg) doses. Patients at high risk of COVID-19 rebound/relapse, e.g., immunocompromised patients, will be given additional ropeginterferon alfa-2b doses even if the Ct is ≥ 30. Approximately 60 patients will be enrolled.

Planned Outcomes

The primary outcome is to compare the time from randomization to the achievement of Ct value ≥ 30 by RT-PCR between ropeginterferon alfa-2b and control groups. Our previous studies have shown safety and promising anti-SARS-CoV-2 activities in patients with moderate or severe COVID-19. This study will provide valuable data in patients with COVID-19 and comorbidities, for whom safe and effective treatment is urgently needed.

Trial Registration Number

This trial is registered at ClinicalTrials.gov (Identifier NCT05808322).

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Data Availability

Data will be available to external researchers upon reasonable request from the investigator and PharmaEssentia.

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Acknowledgements

We would like to thank study coordinators and nurses, and all other investigators and study participants in the study. We are grateful to the patients and their families.

Medical Writing/Editorial Assistance

The authors completed the writing and edition of the manuscript without any medical writing/editorial assistance.

Funding

This study, the journal’s Rapid Service Fee, and the Open Access Fee are sponsored by PharmaEssentia Corporation.

Author information

Authors and Affiliations

  1. Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital, No. 7, Chung-Shan South Road, Taipei, 10002, Taiwan

    Wang-Da Liu & Wang-Huei Sheng

  2. Department of Medicine, National Taiwan University Cancer Center, Taipei, Taiwan

    Wang-Da Liu & Wang-Huei Sheng

  3. Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

    Hsin-An Hou

  4. Division of Rheumatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

    Ko-Jen Li

  5. Medical Research and Clinical Operations, PharmaEssentia Corporation, Taipei, Taiwan

    Albert Qin & Chan-Yen Tsai

  6. School of Medicine, National Taiwan University College of Medicine, No. 1, Jen Ai Road, Section 1, Taipei, 10051, Taiwan

    Wang-Huei Sheng

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Contributions

All authors (W-DL, H-AH, K-JL, AQ, C-YT, and W-HS) contributed to the study conception and design. The first draft of the manuscript was written by W-HS, AQ and C-YT. All authors commented on previous versions of the manuscript and have read and approved the final manuscript.

Corresponding author

Correspondence to Wang-Huei Sheng.

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Conflict of Interest

Wang-Huei Sheng, Wang-Da Liu, and Ko-Jen Li declare no conflict of interest. Hsin-An Hou declares the honorarium, travel and research support from PharmaEssentia Corporation. Albert Qin and Chan-Yen Tsai work for PharmaEssentia Corporation.

Ethical Approval

The study is approved by the institutional review board of NTUH IRB (approval number 202302136MIPD) and follows the principles of the Declaration of Helsinki for all human experimental investigations. Informed consent will be obtained from all participating patients.

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Liu, WD., Hou, HA., Li, KJ. et al. Study Protocol of a Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in COVID-19 Patients with Comorbidities. Adv Ther 41, 847–856 (2024). https://doi.org/10.1007/s12325-023-02715-7

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  • DOI: https://doi.org/10.1007/s12325-023-02715-7

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